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Main outcome | REGRESSION | To assess the effect of actual exposure to the POINCARE-2 strategy on vital status at Day60, two different analyses were carried out: (1) a “naive” logistic regression model adjusted for potential confounders (model 1); and (2) a logistic regression model with the addition of an instrumental variable using the two-stage residual inclusion (2SRI) method [To identify potential confounders in the association between exposure to the strategy and outcomes, we compared patients’ characteristics at admission according to the exposure to the strategy, using logistic regression models adjusted for both ICU and group. Patients’ characteristics that were associated with both the outcome of interest and the score of exposure to POINCARE-2 strategy with a Hypotheses of log-linearity and absence of multiple colinearity were verified before implementation of the regression models, using the Hosmer–Lemeshow test [In order to meet the assumptions of relevance, independence, and exclusion restriction, we chose the group (strategy Finally, we used the Durbin-Wu-Hausman [We handled missing data using multiple imputation (MI), with the number of imputation datasets defined according to the rule of the percentage of missing observations [ | PMC10626740 | |
Subgroup analyses | REGRESSION, ACUTE RESPIRATORY DISTRESS SYNDROME, SEPTIC SHOCK | We added an interaction term to the naive logistic regression model (model 1) to test for a possible subgroup effect of the POINCARE-2 strategy according to the main cause of admission (septic shock, Acute Respiratory Distress Syndrome (ADRS), Central Nervous System (CNS) injury, or other). | PMC10626740 | |
Sensitivity analyses | We conducted sensitivity analyses for the main outcome in the subsample of complete cases. | PMC10626740 | ||
Secondary outcomes | renal damage, RIFLE, VFDs | REGRESSION, EVENT, END STAGE RENAL DISEASE, SECONDARY | We used zero-inflated negative binomial (or zero-inflated Poisson) mixed models to assess the effect of exposure to the POINCARE-2 strategy on the cumulative number of MVFDs and VFDs. Logistic regression models adjusted for potential confounders were computed to examine the effect of the strategy on the occurrence of at least one unexpected harmful event or renal damage. We conducted all secondary analyses on complete cases only. We excluded from the RRTFDs analysis patients who were already at the worst stage of the RIFLE classification (i.e., “end stage renal disease”) at Day2.We used SAS 9.4 (SAS Institute, Inc) and R v4.0.3, with a level of significance set at 0.05. | PMC10626740 |
Ethics | Because the POINCARE-2 strategy focused on health care organization, written informed consent was waived in accordance with French law (Bill number 2012–300 on March 5, 2012 about research involving humans). | PMC10626740 | ||
Results | PMC10626740 | |||
Patients’ characteristics at admission | critically ill | CRITICALLY ILL | A total of 1361 patients were included in the present study, i.e. 718 in the control group and 643 in the strategy group (Fig. Flowchart of critically ill patients recruited and followed up in the POINCARE-2 trial | PMC10626740 |
Exposure to the POINCARE-2 strategy | Mean (SD) score of exposure to the strategy was 80.5 (19.3) in the strategy group vs. 55.2 (24.6) in the control group (overall, 67.1 (25.6)). Overall, 446 (69.4%) patients in the strategy group vs. 178 patients (24.8%) in the control group, had a score of exposure to the strategy ≥ 75 and were further considered as exposed to the strategy. Accordingly, despite higher scores of exposure, implementation of the strategy was not optimal in the strategy group, and a significant proportion of patients from the control group received at least some part of the strategy.Implementation of the various components of the POINCARE-2 strategy are described in Table Characteristics of patients’ stays and implementation of the POINCARE-2 strategyPatients exposed to POINCARE-2 strategy were more likely to be older ( | PMC10626740 | ||
Mortality and safety during follow-up | myocardial infarction | HYPERNATREMIA, SECONDARY, MYOCARDIAL INFARCTION | Vital status at Day 60 and safety outcomes are described in Table Occurrence of primary and secondary outcomes(#) RRT: Renal-replacement therapyForty-five (3.3%) patients presented at least one episode of hypernatremia > 155 mmol/L, and 14 (1.0%) had an episode of mesenteric or myocardial infarction during follow-up. | PMC10626740 |
Effect of the exposure to the POINCARE-2 strategy on 60-day mortality | PMC10626740 | |||
Results from instrumental variable analysis | Exposure to the POINCARE-2 strategy was not associated with 60-day mortality both in the MI dataset (OR | PMC10626740 | ||
Results according to cause of admission: subgroup analyses | ACUTE RESPIRATORY DISTRESS SYNDROME | Results of the subgroup analyses are presented in Table Effect of the exposure to the POINCARE-2 strategy on vital status at Day60 according to the main cause of admission*ARDS: Acute respiratory distress syndrome ~ CNS: Central nervous system | PMC10626740 | |
Effect of exposure to the POINCARE-2 strategy on secondary outcomes | SECONDARY | Results for secondary outcomes are presented in Additional file | PMC10626740 | |
MVFDs | After adjustment for potential confounders, we found a negative association between exposure to the strategy and MVFDs, both on the imputed and on the complete case datasets (Additional file | PMC10626740 | ||
VFDs | VFDs | We found no significant association of the exposure to the POINCARE-2 strategy with the cumulative number of VFDs between Day0 and Day28 (Additional file | PMC10626740 | |
Unexpected harmful events | hypernatremia, hypokalemia, hypotension | HYPERNATREMIA, EVENT, EVENTS | We found no significant association between exposure to the POINCARE-2 strategy and occurrence of at least one unexpected harmful event (i.e., arterial hypotension between Day2 and Day14, hypernatremia between Day2 and Day14, hypokalemia between Day2 and Day14, and acute ischemic events between Day3 and discharge) (Additional file | PMC10626740 |
Renal damage | RIFLE | We found no significant association between exposure to the POINCARE-2 strategy and worsening in the RIFLE criteria between Day3 and Day14 (Additional file | PMC10626740 | |
Discussion | critically ill | CRITICALLY ILL, FLUID OVERLOAD | Similarly to the intention-to-treat analyses [These results are in line with previous findings. While the deleterious effect of fluid overload on mortality has been repeatedly reported in observational studies in critically ill patients [The highest evidence derived from randomized controlled trials (RCT) comes from intention-to-treat analyses of individual RCT [Having a closer look at the components of POINCARE-2 strategy, our results suggest that the proportion of daily weighing performed, as well as the total dose of diuretics, increased with an increasing exposure to the strategy. The daily average fluid intake, however, did not vary in the same way with the score of exposure to the strategy. This suggests that intensivists were more adherent to components of the strategy favoring fluid depletion than those favoring water and salt restriction to control fluid balance. They might also not be aware enough of how much creep fluid accounts for daily fluid intake. These findings are in line with the ones of a cross-sectional study among 524 critical care specialists showing that diuretics were the most frequently prescribed treatment to prevent fluid overload (66%). In this study, most intensivists reported using diuretics to treat fluid overload on at least 50% of days working in ICU [Our study suffers from some limitations. First, although experts agreed to rank the patients with a score of exposure to the strategy > 75 as most exposed, their agreement on exposure to the strategy in patients with lower score of exposure was less consensual. Accordingly, the defined unexposed group mixed unexposed patients and somewhat exposed patients, without us being able to separate the last ones from the first ones. This might have biased our results towards the null. In addition, the highest 60-day mortality was observed both in the lowest ([0–25[) and in the highest ([75–100]) score of exposure categories, which either corroborates a potential bias on measurement of exposure to the strategy in the lowest score category or suggests that the effect of exposure to the strategy on mortality is J-shaped. This would mean that rather than discrediting conservative strategies, we might consider applying them using restrictive therapeutic targets and/or during a limited time window. Second, the participating ICUs were equipped with different weigh scales. Despite our recommendation to tare each scale before each weigh assessment, this might have led to measurement bias. Third, we did not size the trial sample to handle adjustment for multiple confounders or to use an instrumental variable without loss of power. This might have resulted in our inability to detect a significant effect of the strategy.Our study further highlights the difficulty of demonstrating an effect of a conservative strategy in critical care practice, despite evidence of the deleterious effect of fluid overload. Given the dynamic nature of the POINCARE-2 strategy, and because of the constant need to adapt this strategy to patients’ clinical status, which varies over time, alternative statistical methods might be required in future studies. Especially, the target trial emulation approach, by simulating the various possible intervention regimens over time, could help compare the various treatment sequences and determine the most appropriate time to start fluid balance control after ICU admission [Furthermore, the POINCARE-2 strategy relied on multiple components and involved multiple health professionals (i.e., nurses and assistant nurses for weighing and administration of prescribed medications, and intensivists for prescriptions). As thus, it can be considered as a complex intervention, as defined by the Medical Research Council [ | PMC10626740 |
Conclusions | critically ill | CRITICALLY ILL | As-treated analyses did not show a significant effect of the POINCARE-2 fluid balance control strategy on mortality in a broad population of critically ill patients. Further research, such as target trial emulation or a complete process evaluation, might help understand the conditions required for conservative strategies to be effective. | PMC10626740 |
Acknowledgements | Gilles | Data safety management board: Jean-François Timsit, MD PhD, Hôpital Bichat, Paris, Yves Le Tulzo, MD PhD, CHU de Rennes, Gilles Hilbert, MD PhD, CHU de Bordeaux. | PMC10626740 | |
Author contributions | POINCARE-2 trial was designed jointly by NA and PEB. CHRU Nancy, Inserm, Université de Lorraine, CIC, Epidémiologie Clinique was in charge of data collection, management, analyses, and interpretation in collaboration with the authors. Randomization and data management were supervised by JMV, and statistical analyses conducted by AM, CA, and MS. AM and NA first drafted the manuscript. All authors revised the manuscript critically for important intellectual content. All authors vouch for completeness and accuracy of clinical data and analyses and for adherence to the trial protocol. | PMC10626740 | ||
Funding | POINCARE-2 trial was supported by a grant from the French Ministry of Health, | PMC10626740 | ||
Availability of data and materials | Due to restrictions pertaining to French laws, the datasets generated and/or analyzed during POINCARE-2 trial are not publicly available. However, data transfer agreement remains possible and data can be made available upon reasonable request to the corresponding author. | PMC10626740 | ||
Declarations | PMC10626740 | |||
Ethics approval and consent to participate | The Comité de Protection des Personnes Est III, Grand-Est, North-East France, has reviewed and approved POINCARE-2 trial (ID-RCB: 2015-A00662-47).Patients and their kin were informed about the trial protocol and their right to refuse to participate. Written informed consent was waived in accordance with the French law (Bill number 2012-300 on March 5, 2012 about research involving humans). | PMC10626740 | ||
Consent for publication | Not applicable. | PMC10626740 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10626740 | ||
References | PMC10626740 | |||
Key Points | PMC10448373 | |||
Question | microvascular disease | How does coronary venous pressure influence myocardial resistances in patients with microvascular disease? | PMC10448373 | |
Findings | microvascular disease | In this blinded, physiology end point, sham-controlled randomized clinical trial that included 20 adults with microvascular disease, an increase in coronary venous pressure led to significantly decreased resting and hyperemic microvascular resistances. | PMC10448373 | |
Meaning | MICROVASCULAR ANGINA | In patients with microvascular angina, the coronary venous circulation may be a novel therapy target. | PMC10448373 | |
Importance | microvascular angina | MICROVASCULAR ANGINA | The role of the coronary venous circulation in regulating myocardial perfusion and its potential in treating microvascular angina is unexplored. | PMC10448373 |
Objective | MICROVASCULAR ANGINA | To evaluate whether an increase in coronary venous pressure modifies microvascular resistance in patients with microvascular angina. | PMC10448373 | |
Design, Setting, and Participants | epicardial coronary disease, microvascular dysfunction, pulmonary or kidney disease, angina pectoris | ATRIOVENTRICULAR BLOCK, VALVULAR HEART DISEASE, CARDIOMYOPATHY | This was a blinded, sham-controlled, crossover, randomized clinical trial that enrolled participants between November 2021 and January 2023. Participants for this physiology end point study were recruited from the Cardiology Center of the University of Medicine in Mainz, Germany. Patients with moderate/severe angina pectoris (Canadian Cardiovascular Society class 2-4) due to microvascular dysfunction (as defined by the thermodilution-based index of microvascular resistance >25 mm Hg × s). Exclusion criteria were epicardial coronary disease, second- and third-degree atrioventricular block, severe valvular heart disease, cardiomyopathy, and pulmonary or kidney disease. | PMC10448373 |
Intervention | cardiac coronary sinus | Inflation of an undersized balloon placed in the cardiac coronary sinus (CS), hereafter referred to as | PMC10448373 | |
Main Outcomes and Measures | Hemodynamic parameters, including aortic (Pa) and distal (Pd) coronary pressure, coronary sinus pressure (Pcs), right atrial pressure (Pra), and the mean transit time (inverse of blood flow [Tmn]), were measured. | PMC10448373 | ||
Results | hyperemia, diabetes | HYPERTENSION, HYPERCHOLESTEROLEMIA, HYPEREMIA, DIABETES | A total of 20 patients (median [IQR] age, 69 [64-75] years; 11 female [55.0%]) were included in the study. Two patients (10%) had diabetes, 6 (30%) had hypercholesterolemia, 15 (75%) had hypertension, and 3 (15%) were active smokers. The inflation of the CS balloon caused a significant increase in CS pressure at rest and during hyperemia (300% and 317% increase, respectively, compared with sham, both | PMC10448373 |
Conclusion and Relevance | reduction of microvascular resistances | DISEASE, MICROVASCULAR ANGINA | Increased coronary venous pressure led to a reduction of microvascular resistances in patients with microvascular angina, a mechanism with potential implications for the therapy of this complex disease. | PMC10448373 |
Trial Registration | ClinicalTrials.gov Identifier: | PMC10448373 | ||
Introduction | microvascular dysfunction, Microvascular angina pectoris | Microvascular angina pectoris (MVA) is a complex clinical condition in which functional and/or structural changes in the coronary microcirculation determine an increase in vascular tone compromising myocardial perfusion.Empirical observations suggest that implantation of a coronary sinus reducer may improve myocardial perfusion and decrease symptoms in patients with microvascular anginaThe study presented here aimed to investigate whether an increase in coronary sinus pressure may lead to a measurable change in coronary microvascular resistance in patients with microvascular dysfunction, which may pave the way for an interventional approach. | PMC10448373 | |
Methods | PMC10448373 | |||
Study Design | This study was a sham-controlled, crossover, randomized clinical trial to investigate the effect of changes in coronary venous pressure on microvascular resistances. The protocol (described in detail elsewhere; | PMC10448373 | ||
Study Population | epicardial stenosis, chronic angina, ischemia, pulmonary or kidney disease, microvascular dysfunction | ATRIOVENTRICULAR BLOCK, ISCHEMIA, VALVULAR HEART DISEASE, CARDIOMYOPATHY | Patients had chronic angina (Canadian Cardiovascular Society 2-4) without epicardial stenosis, reversible ischemia on noninvasive testing, and evidence of microvascular dysfunction (index of microvascular resistance [IMR] ≥25 mm Hg × s). Main exclusion criteria were second- or third-degree atrioventricular block, any valvular heart disease, any cardiomyopathy, and pulmonary or kidney disease. | PMC10448373 |
Procedures | PMC10448373 | |||
Randomization and Intervention | hyperemia | HYPEREMIA | Vasoactive therapies were suspended for more than 12 hours before measurements were taken. Patients were randomly assigned 1:1 to 1 of 2 arms (sham/balloon or balloon/sham), with each patient undergoing invasive measurements at rest and during hyperemia in both conditions ( | PMC10448373 |
Study Protocol | microvascular angina | MICROVASCULAR ANGINA | A total of 20 patients with microvascular angina were randomly assigned to treatment in this crossover, sham-controlled trial to assess the effect of inflation of a coronary sinus balloon on myocardial hemodynamic. IMR indicates index of microvascular resistance. | PMC10448373 |
Hemodynamic Measurements | myocardial ischemia | MYOCARDIAL ISCHEMIA | Coronary microvascular function assessments were performed with a wire-based thermodilution method using Pressure Wire X (Abbott Vascular) as per instructions for use; the same hyperemic agent was used for the 2 sets of measurements in each patient (sham and balloon). The mean transit time (Tmn), coronary flow reserve (CFR), and IMR were measured. The absence of drift was confirmed at the end of the measurements. Patients were blinded to the randomization sequence, and hemodynamic data were encoded in the CoroFlow software (Coroventis) and collected by blinded assessors. Coronary flow capacity was measured to identify 4 different regions of myocardial ischemia (eMethods in | PMC10448373 |
Trial End Points | The study’s primary end point was the (hyperemic) IMR during the inflation of the CS balloon as compared with sham. IMR was calculated as [( | PMC10448373 | ||
Statistical Analysis | Randomization was performed by a computer-generated random sequence with permuted blocks. The power calculation was based on previous articles investigating the effect of acute administration of fasudil and enalaprilat on IMR.The primary analysis was performed as a within-participant comparison of the primary parameter using a linear mixed-regression model with a patient random intercept, condition, and period as well as their interaction as fixed factors and age and sex as covariates. Secondary end points were analyzed using the Wilcoxon test. Data are presented as median (IQR). All | PMC10448373 | ||
Results | A total of 20 patients (median [IQR] age, 69 [64-75] years; 11 female [55.0%]; 9 male [45%]) were enrolled in this physiology end point study (eTable in Hemodynamic data are presented in the | PMC10448373 | ||
Hemodynamic Variables and Effects of Balloon Inflation at Rest and During Hyperemia | Abbreviations: CFR, coronary flow reserve; FFR, fractional flow reserve; IMR, index of microvascular resistance; MRR, microvascular resistance reserve; Pa, mean aortic pressure; Pcs, mean pressure in the coronary sinus; Pd, mean distal coronary pressure; Pra, mean pressure in the right atrium; Tmn, mean transit time.The estimated adjusted between-conditions difference (sham-balloon) was 21 (95% CI, 14-28) mm Hg × s (All Randomization sequence, resting resistances, sex, and age did not affect the change in IMR caused by balloon inflation. The decrease in IMR after balloon inflation was largest in patients with the highest sham IMR (Coronary flow capacity was improved by balloon inflation ( | PMC10448373 | ||
The Primary End Point of the Trial | Balloon inflation caused a decrease in resting and hyperemic microvascular resistances. IMR indicates index of microvascular resistance. | PMC10448373 | ||
Discussion | microvascular disease, hyperemia, angina | HYPEREMIA | Many patients undergoing diagnostic coronary angiography for angina have microvascular disease.Animal models in the peripheral circulation show that total vascular resistance within the coronary circulation is determined by vascular resistance and viscosity, with the latter playing a multiplicative role during hyperemia when the capillary bed determines up to 75% of the total myocardial vascular resistance. | PMC10448373 |
Limitations | microvascular dysfunction | DISEASE | This study has some limitations. Of note, a mechanistic study is not designed or powered to assess clinical benefit, and we only studied the effect of a single acute increase in CS pressure in patients with microvascular dysfunction. Whether similar effects occur over chronic periods and in patients with epicardial (as compared with microvascular) disease will have to be investigated. Also, the mechanisms hypothesized are based on evidence from animal models or human in vivo models of the extracardiac circulation. | PMC10448373 |
Conclusions | In this crossover randomized clinical trial, the current findings that an acute increase in CS pressure led to a decrease in microvascular resistance and an increase in blood flow allow hypothesizing that the venous vasculature may be leveraged to improve coronary resistances in patients with MVA. This may have implications for therapy with a coronary sinus reducer. | PMC10448373 | ||
Objective | stroke | STROKE | Investigate feasibility and acceptability of prism adaptation training for
people with inattention (spatial neglect), early after stroke, during usual
care. | PMC9912302 |
Design | Phase II feasibility randomised controlled trial with 3:1 stratified
allocation to standard occupational therapy with or without intervention,
and nested process evaluation. | PMC9912302 | ||
Setting | stroke | STROKE | Ten hospital sites providing in-patient stroke services. | PMC9912302 |
Participants | post-stroke | Screened positive for inattention more than one-week post-stroke; informal
carers. Occupational therapists participated in qualitative interviews. | PMC9912302 | |
Intervention | Adjunctive prism adaptation training at the start of standard occupational
therapy sessions for three weeks. | PMC9912302 | ||
Main measures | RECRUITMENT | Feasibility measures included recruitment and retention rates, intervention
fidelity and attrition. Outcomes collected at baseline, 3 weeks and 12 weeks
tested measures including Nottingham Extended Activities of Daily Living
Scale. Acceptability was explored through qualitative interviews and
structured questions. | PMC9912302 | |
Results | ADVERSE EVENTS | Eighty (31%) patients were eligible, 57 (71%) consented, 54 randomised
(40:13, +1 exclusion) and 39 (74%) completed 12-week outcomes. Treatment
fidelity was good: participants received median eight intervention sessions
(IQR: 5, 12) lasting 4.7 min (IQR: 4.1, 5.0). All six serious adverse events
were unrelated. There was no signal that patients allocated to intervention
did better than controls. Twenty five of 35 recruited carers provided
outcomes with excellent data completeness. Therapists, patients and carers
found prism adaptation training acceptable. | PMC9912302 | |
Conclusions | stroke | STROKE | It is feasible and acceptable to conduct a high-quality definitive trial of
prism adaptation training within occupational therapy early after stroke in
usual care setting, but difficult to justify given no sign of benefit over
standard occupational therapy. | PMC9912302 |
Introduction | stroke, cognitive syndrome | STROKE, RECRUITMENT | There is no robust evidence that any therapy reduces the disabling effects of spatial
inattention (also known as spatial neglect), a cognitive syndrome affecting
awareness towards one side of the body or environment.Prism adaptation training is purported to show short-term relief of spatial deficits
but clinical effectiveness has not been evaluated within adequately powered
trials.Determine the feasibility of a future Phase III randomised controlled
trial, for example, recruitment and retention of stroke survivors and
carers Explore the fidelity and acceptability of intervention in the usual care
setting. | PMC9912302 |
Methods | TIA, stroke, post-stroke, Stroke | TRANSIENT ISCHAEMIC ATTACK, STROKE, STROKE, RECRUITMENT, SECONDARY, REGRESSION, EVENTS, TIA | This was a pragmatic, feasibility Phase II multi-centre stratified randomised
controlled trial with nested process evaluation, designed with collaborative level
patient involvement. The study was approved by the Yorkshire and the Humber NHS
Research Ethics Committee (18/YH/048) and entered on the ISRCTN registry, We monitored trial quality and conduct with a Trial Management Group and an external
Trial Steering Committee. ABa, a stroke survivor, worked with the research team in
designing the study and was a co-applicant on the grant. ABa identified and chaired
a dedicated Patient Carer and Public Involvement advisory group of six stroke
survivors, which met ten times during the study. The advisory group provided input
on all research activities, from documentation through to dissemination. ABa also
represented the group on the trial management group. Two stroke survivors,
independent of the advisory group, were members of the trial steering committee.Participants were recruited between March 2019 and January 2020 with phased site
opening. Data collection ended in April 2020. Follow-up assessments took place 3 and
12 weeks after the start of intervention. Reporting follows the CONSORT 2010
statement: extension to randomised pilot and feasibility trials (see We recruited participants from NHS in-patient stroke services (provided across 10
acute hospitals and linked rehabilitation facilities) in England. Patients were
eligible if they were over 18 years old; had a confirmed stroke (ischaemic or
haemorrhagic); positive for spatial inattention at routine screening; had spatial
inattention impacting on functional performance; at least one week post-stroke;
eligible for standard occupational therapy (for at least one session); able to
provide informed consent (or personal/professional consultee available); able to sit
with support and perform brief research intervention (e.g. sufficient vision,
physical mobility and cognition to be able to participate).Initially we only included in-patients who were one to four weeks post-stroke but in
August 2019 obtained approval for an amendment to widen eligibility beyond four
weeks post-stroke. Staff taking consent followed the Mental Capacity Act
(2005)NHS occupational therapists identified in-patients with spatial inattention as part
of routine clinical care, screening patients for inattention on admission as per
each local site practice. NHS research support staff then screened patients for full
trial eligibility and gained consent. We used accessible information sheets and
consent forms designed with our patient advisory group, alongside consultee
declarations for participants deemed unable to give informed consent. NHS research
support staff collected standard demographic and clinical data following recruitment
including National Institutes of Health Scale (NIHSS). Occupational therapists
completed baseline assessments as soon as possible after consent. Occupational
therapists also provided a subjective assessment of the severity of patient's
inattention on a 4-point scale (none, mild, moderate, severe) using a combination of
functional observations and their clinical judgement. Participants no longer
displaying inattention at the baseline assessments were withdrawn prior to
randomisation.Patient participant demographics and baseline clinical data by study arm.NIHSS: National Institutes of Health Stroke Scale; mRS: modified Rankin
score; TIA: transient ischaemic attack; KF-NAP: Kessler Foundation
Neglect Assessment Process.We allocated treatment using a 3:1 ratio stratified by site (3 intervention: 1
control), using an independent, web-based, third-party (For participants in the intervention arm, prism adaptation training was offered once
a day at the start of routine occupational therapy sessions, for up to three weeks,
five days a week. The training lasted no more than 5 min plus set up time (seating
the participants and fitting the glasses). Participants sat at a table in front of a
semi-circular board raised approximately 18–26 cm off the table. Participants wore
25 dioptre (12.5°) wedge prism glasses adjusted for left or right sided inattention
as appropriate. Occupational therapists or therapy assistants presented a target at
the opposite end of the board and asked the participant to reach under the board to
touch the target, concealing all but the terminal part of the patient's arm. The
therapist presented the target in an unpredictable order and participants pointed to
the target for a maximum of 90 movements, or if movements were slow for ≤5 min. The
prisms were removed after the pointing task. Details of the prism adaptation session
were recorded, including location, delivering staff member, number of movements and
length of session.We trained in-patient occupational therapists and therapy assistants in intervention
delivery. We also trained community staff to provide the intervention on discharge
if required. A member of the research team was present for the first prism
adaptation training session for each participant. See Template for Intervention
Description and Replication (TIDieR) checklist (Following prism removal, participants then received standard occupational therapy. In
consultation with therapists, we specified that therapy following prism adaptation
should be patient-facing activities in which inattention would affect participation.
These were either activities focused on reducing inattention or, for example,
functional activities of daily living training in which inattention would affect
performance. Non-patient facing therapy activities (e.g. family meetings) were not
performed following prism adaptation and staff were asked not to perform prism
adaptation prior to standardised or functional assessments where the intervention
could impact performance. The treating occupational therapist recorded the
frequency, amount and content of each occupational therapy session the participant
received during the three-week period using a study-specific data collection
form.The control group received standard occupational therapy (with no prism adaptation
training), using the same type of patient-facing activities as the intervention
group. Therapy staff recorded the sessions in the same way as the intervention group
for the three-week period. In both groups therapy was personalised in line with the
National Clinical Guidelines for Stroke,We collected data on candidate outcome measures at three time points. Occupational
therapists completed the baseline assessment; NHS research support staff or the
study research team collected 3- and 12-week outcomes, either in hospital or at the
participant's residence if transferred from in-patient care. The COVID-19 lockdown
prevented face-to-face collection of the last few outcome measures however it was
possible to collect some by phone. We trained all staff required on baseline and
outcome assessment delivery. Outcomes were collected by staff unaware of the patient
group where possible.We collected the following assessments from patient participants at all three
timepoints, baseline and 3 and 12 weeks from the start of the intervention: Hearts cancellation test: a subtest of the Oxford Cognitive
Screen.Star cancellation: a subtest of the Behavioural Inattention
Test.Reading test: based on the Radner Reading Test.Kessler Foundation Neglect Assessment Process (KF-NAP)At 12 weeks only we also collected the: Nottingham Extended Activities of Daily Living scale (NEADL),Patient Reported Evaluation of Cognitive State (PRECiS),EQ5D5LModified Rankin score (mRS),Adverse events up to 12 weeksWe collected the following outcome data from carer participants at 12 weeks only:
Carer experience scaleModified carer strain indexSelf-reported informal carer health service useWe collected data to support the process evaluation through brief structured verbal
questions with all patient participants receiving prism adaptation training at 3
weeks post-intervention; and a purposive sample of face-to-face qualitative
interviews with seven patient and five carer participants at 12 weeks; and telephone
interviews with a purposive sample of 10 occupational therapists following delivery
of at least one prism adaptation training session.Responses to structured questions were coded by PM and JW to identify key phrases and
frequency of these across the data. We uploaded transcribed qualitative interview
data to NVivo (version 13). Through repeated reading of the transcripts ED and JT
familiarised themselves with the data to identify initial codes. Following initial
coding, a discussion and comparison was undertaken whereby a consensus was reached,
and six themes identified using thematic analysis.As a Phase II feasibility trial, we did not have a predetermined sample size.
Instead, we predicted a recruitment total of 60–80, based on 1–2 participants per
month from each site for 12 months (allowing for phased site opening). We reported
percentages to assess recruitment, fidelity and attrition. We calculated mean
difference and 95% confidence interval for our primary and secondary outcomes on an
intention-to-treat basis. We sought outcome data for all participants regardless of
treatment adherence unless consent to follow-up was explicitly withdrawn. As there
were small numbers of participants, we could not adjust analyses for site
(stratification criteria) and baseline severity as planned. Therefore, we used
unadjusted regression to obtain the mean difference and 95% CI of the difference for
each outcome assessment at T2. We used Stata 14 statistical software. | PMC9912302 |
Discussion | stroke, strokes, post-stroke, Fatigue | STROKE, STROKES, RECRUITMENT, ATTRITION | We demonstrated that it would be feasible and acceptable to conduct a definitive
trial of a rehabilitation intervention for stroke survivors with inattention,
delivered by NHS occupational therapists, beginning very early after stroke in the
inpatient usual care rehabilitation setting. We established realistic estimates of
recruitment (maximum 2 patients per site per month), retention, data completeness
and participant characteristics, and provided data to inform the primary outcome
measure and calculate sample size for future trials in this population.It was not possible for NHS research support staff to complete all outcome
assessments, nor for outcome assessors to remain blinded. Attrition in the study was
low. Treatment fidelity for prism adaptation training was good in terms of duration
and timing of delivery, however recording of the content of occupational therapy
sessions was incomplete and needs some revision. Study procedures and prism
intervention delivery were acceptable to patients, carers and therapists.Although the study was not powered to give a conclusion on the effectiveness of prism
adaptation training, none of the outcome measures showed any sign of benefit from
intervention. Furthermore, a proof-of-concept study (reported separately) did not
find evidence to suggest improved engagement in occupational therapy following one
session of prism adaptation training. Thus, we cannot justify taking prism
adaptation training, provided as per this study and with this early post-stroke
population, to a definitive trial.There are several potential explanations for our findings. There is no standard
protocol for prism adaptation delivery, for example, some studies delivered 10 or
more sessions per day over two weeksIn addition, time since stroke and physical ability early post-stroke may influence
the effect of prism adaptation. Fatigue early post-stroke may mean a higher
dose/intensity of prism adaptation is not well tolerated, particularly because
people with inattention often have more severe strokes and premorbid
difficulties.Although the sample size of this feasibility study lacks statistical power to
identify small but realistic and potentially worthwhile effects, our conclusions are
underpinned by our adequately powered proof of concept analysis (reported
separately) which ruled out a measurable effect on immediate patient engagement in
occupational therapy. The study targeted a potential sample size of 60–80
participants, which resulted in 53 eligible and consenting people. This demonstrated
it would be feasible to recruit to a definitive study in the post-acute stage with a
slightly longer recruitment window. Whilst our study reflects some existing
findings, most existing randomised controlled trials have small samples, many with
less than 50 participants, and therefore comparisons should be treated with
caution.Our choice of outcome assessments may provide limitations. Many participants assessed
at 12 weeks were still in hospital, limiting the number of activities of daily
living they could report completing on the primary outcome. This also impacted on
the relevance of collecting outcome data from carer participants. Despite training,
some assessments were not carried out in line with standardised instructions,
particularly at baseline (e.g. asking participants to cancel large rather than small
stars).Despite concluding that prism adaptation training, as provided by this study, is not
a candidate intervention for a definitive trial, we stress alternative
rehabilitation interventions for people with inattention early after stroke are
needed. We recommend exploring how patients assessed as physically or cognitively
unable to participate in the intervention might be able to benefit from future
interventions for inattention. We identified several methodological changes for a
future trial, including: choice or timing of most appropriate primary outcome early
post-stroke; facilities such as quiet space away from the bedside to facilitate
effective intervention delivery; and a need for outcome assessors employed as part
of the research team. Blinded assessors are expensive to achieve in rehabilitation
trials and trade-offs are required. | PMC9912302 |
Clinical messages | stroke, post-stroke inattention, post-stroke | STROKE | Patients with post-stroke inattention, carers and therapists are willing
and able to participate in research early post-stroke in a hospital
setting.Although brief prism adaptation training was acceptable to deliver at the
start of occupational therapy sessions, we did not detect any benefit
over and above occupational therapy early after stroke. | PMC9912302 |
Supplemental Material | PMC9912302 | |||
sj-doc-1-cre-10.1177_02692155221134060 - Supplemental material for A
study of prisms and therapy in attention loss after stroke (SPATIAL): A
feasibility randomised controlled trial | stroke, attention loss | STROKE | Click here for additional data file.Supplemental material, sj-doc-1-cre-10.1177_02692155221134060 for A study of
prisms and therapy in attention loss after stroke (SPATIAL): A feasibility
randomised controlled trial by Verity Longley, Kate Woodward-Nutt, Ailie J.
Turton, Katie Stocking, Matthew Checketts, Ann Bamford, Emma Douglass, Julie
Taylor, Julie Woodley, Pam Moule, Andy Vail and Audrey Bowen in Clinical
Rehabilitation | PMC9912302 |
sj-docx-2-cre-10.1177_02692155221134060 - Supplemental material for A
study of prisms and therapy in attention loss after stroke (SPATIAL): A
feasibility randomised controlled trial | stroke, attention loss | STROKE | Click here for additional data file.Supplemental material, sj-docx-2-cre-10.1177_02692155221134060 for A study of
prisms and therapy in attention loss after stroke (SPATIAL): A feasibility
randomised controlled trial by Verity Longley, Kate Woodward-Nutt, Ailie J.
Turton, Katie Stocking, Matthew Checketts, Ann Bamford, Emma Douglass, Julie
Taylor, Julie Woodley, Pam Moule, Andy Vail and Audrey Bowen in Clinical
Rehabilitation | PMC9912302 |
sj-docx-3-cre-10.1177_02692155221134060 - Supplemental material for A
study of prisms and therapy in attention loss after stroke (SPATIAL): A
feasibility randomised controlled trial | stroke, attention loss | STROKE | Click here for additional data file.Supplemental material, sj-docx-3-cre-10.1177_02692155221134060 for A study of
prisms and therapy in attention loss after stroke (SPATIAL): A feasibility
randomised controlled trial by Verity Longley, Kate Woodward-Nutt, Ailie J.
Turton, Katie Stocking, Matthew Checketts, Ann Bamford, Emma Douglass, Julie
Taylor, Julie Woodley, Pam Moule, Andy Vail and Audrey Bowen in Clinical
Rehabilitation | PMC9912302 |
sj-docx-4-cre-10.1177_02692155221134060 - Supplemental material for A
study of prisms and therapy in attention loss after stroke (SPATIAL): A
feasibility randomised controlled trial | stroke, attention loss | STROKE | Click here for additional data file.Supplemental material, sj-docx-4-cre-10.1177_02692155221134060 for A study of
prisms and therapy in attention loss after stroke (SPATIAL): A feasibility
randomised controlled trial by Verity Longley, Kate Woodward-Nutt, Ailie J.
Turton, Katie Stocking, Matthew Checketts, Ann Bamford, Emma Douglass, Julie
Taylor, Julie Woodley, Pam Moule, Andy Vail and Audrey Bowen in Clinical
Rehabilitation | PMC9912302 |
References | PMC9912302 | |||
1. Introduction | fracture, fractures | ADVERSE EVENTS, SECONDARY, RECRUITMENT | Although hip fractures are common and severe, there is insufficient evidence concerning which type of rehabilitation is most beneficial. The primary aim of this three-armed pilot study was to investigate any difference in outcome after hip fractures between and within groups in terms of balance, everyday activities, and health-related quality of life (HRQoL) following different home rehabilitation interventions. Further aims were to study feasibility and to suggest, if necessary, adjustments to the protocol for a future full randomized controlled trial (RCT). In total, 32 persons were included in this study. The intervention groups underwent the HIFE program with or without an inertial measurement unit, while the control group underwent standard rehabilitation. Within- and between-groups differences in outcomes and feasibility outcomes in terms of recruitment and retention rates were analyzed, and the ability to collect primary and secondary outcomes was assessed. Balance, measured as postural sway, showed no significant improvement in any group. All three groups improved in functional balance (By 2050, around 8 million hip fractures are expected to occur per year [A hip fracture increases a person’s fear of falling and, thus, restricts activity [One type of rehabilitation program is the High-Intensity Functional Exercise (HIFE) program, which contains exercises for balance, progressive strength training, and functional exercises. The HIFE program was developed for frail older adults with lower limb problems at different functional levels living in a nursing home. It is designed to help them improve balance, lower-limb strength, and mobility in their own home [In the Medical Research Council (MRC) framework for designing and evaluating complex interventions in health care, feasibility studies constitute important steps to inform further full-scale testing, e.g., by performing an RCT [The primary aim of this pilot and feasibility study was to investigate the feasibility of an RCT in terms of the rates of recruitment, retention, and adverse events, as well as regarding outcome data collection. A further aim was to study outcome differences after hip fractures regarding balance, everyday activities, and health-related quality of life across groups following different home rehabilitation interventions. Furthermore, if found necessary, suggested adjustments to the protocol could be made to conduct a full randomized controlled trial (RCT). | PMC9967499 |
2. Materials and Methods | PMC9967499 | |||
2.1. Study Design | A three-armed pilot study was designed. Two intervention groups were included, namely, (1) participants following the HIFE program and (2) participants following the HIFE program, with the addition of data collection using a wearable device measuring body position and movement, and (3) a control group. The design of this study has been published in a detailed study protocol [ | PMC9967499 | ||
2.2. Study Setting | fracture | The study was performed in Malmö, the third largest city in Sweden, with approximately 330,000 inhabitants. Every year, about 700 individuals are admitted and treated for a hip fracture at Skåne University Hospital in Malmö [ | PMC9967499 | |
2.3. Recruitment and Participant Inclusion/Exclusion | fracture, major neurological diseases, cognitive impairment, cognitive disease | The inclusion criteria were being hospitalized, treated for a hip fracture, and in need of home-based rehabilitation. The exclusion criteria were (1) not being able to read and understand Swedish, (2) having major neurological diseases impacting walking and balance, and (3) having a diagnosed cognitive disease or severe cognitive impairment affecting the ability to perform exercises or use the wearable device, which was assessed by a physiotherapist.Those fulfilling the inclusion criteria were informed about the study after hospital discharge by a physiotherapist (PT). Written informed consent was provided by those agreeing to participate. | PMC9967499 | |
2.4. Randomization | A cluster randomization procedure was applied, a 6-based cluster, thus giving each cluster 2 participants to each intervention arm. Sealed envelopes were used. The numbers were randomly drawn by a person that had no contact with the participants or the researcher. | PMC9967499 | ||
2.5. Intervention | PROGRESSION | All participants received an individually tailored intervention in either one of the intervention groups (HIFE) or the control group (standard rehabilitation). In all three groups, home visits by the physiotherapist were included. At these home visits, exercises were added or adjusted when needed.Intervention group 1: This group followed the HIFE program, and other exercises were added when needed. The HIFE program consists of 5 training categories depending on the individual’s level. In every category, several exercises are included (Intervention group 2: This group followed the HIFE program but was also given feedback by an inertial measurement unit (IMU), which they wore 24 h a day until the end of the rehabilitation period (The equipment used in HIFE was step boards, chair cushions (5 cm height minimum), weighted belts (1 kg), soft pads, mattresses, balls, bean bags, belts with handles, and chairs without arm support; all equipment was portable. Progression for each exercise could, for example, be achieved by providing less assistance or softer surfaces or by increasing the load of the weight belt. Control group: Participants were offered individually tailored standard rehabilitation, which included walking and functional exercises [ | PMC9967499 | |
2.6. Outcomes | Feasibility was the main outcome measure and measured by means of Patient-related outcomes were balance-measured as postural sway, functional balance, functional independence in everyday activities, and health-related quality of life (HRQoL). Measures of postural sway, especially in the medio-lateral direction, have been shown to be indicators of future falls [HRQoL was evaluated using the EQ-5D [ | PMC9967499 | ||
2.7. Measurement | An IMU measures linear acceleration and rotation. The study used 2 different types of IMUs, one for intermittent measurements of postural sway and one for continuous measurements of body positions and movement. The IMU that measured postural sway was used in all 3 groups to measure postural sway in the anterior/posterior and medio/lateral directions at baseline and follow-up. During the measurements, the IMU was attached to the back, and the participant stood still for 30 s. An IMU attached to the back has shown an equally good ability to discriminate between different conditions in postural sway as other placements [ | PMC9967499 | ||
2.8. Procedure | fracture | SECONDARY | Before the data collection, all health care personnel involved in hip fracture rehabilitation in Malmö municipality were trained in the HIFE program and in using the IMU device. Several workshops were held with the participation of leaders from the rehabilitation unit and technicians who developed the IMU device. After the data collection was completed, a final workshop was held to obtain information from the involved physiotherapists regarding the feasibility of the study.Data on primary and secondary outcomes were collected at baseline, together with participant characteristics (age, sex, the method of surgery, and medication), by the PT. Data on outcomes were also collected at the end of the rehabilitation period. The responsible PT also took notes in case there were deviations from the protocol or withdrawal from the study. | PMC9967499 |
2.9. Statistical Methods | SECONDARY | A previous study was used to calculate statistical power [The data were not normally distributed, and due to the small sample sizes, the difference in the primary and secondary outcomes between the 3 groups was analyzed using the Kruskal–Wallis test. To measure within-group differences, the Mann–Whitney U test was used. No adjustment for the number of comparisons was conducted, as all the variables were analyzed independently. Following the CONSORT statement, on-treatment analyses were applied. SPSS version 28.0 was used (SPSS Inc., Chicago, IL, USA). | PMC9967499 | |
3. Results | intramedullary nail fixation, fracture, Pain | A total of 32 participants were included in the study, 25 women and 7 men aged between 56 and 95 years of age (Md 85 years), during the period of January 2021 to June 2022. A total of 10 persons had had a hip arthroplasty, 19 had had intramedullary nail fixation, and 3 had had other surgical treatments. A total of 22 persons used cardiovascular medication, 4 used psychotropic medication, 2 used anticonvulsants, and 22 used other medication. Pain medication in relation to the hip fracture was used by 24 persons.Among the 32 persons included in the study, 11 were randomized to intervention group 1 (HIFE program), 10 were randomized to intervention group 2 (HIFE program + IMU), and 11 were randomized to the control group ( | PMC9967499 | |
3.1. Feasibility Measures | RECRUITMENT | In total, there were 61 qualified participants for the feasibility study. The recruitment rate was 52%, and the retention rate 78% at the primary follow-up assessments. Seven participants dropped out of the study. The reasons for drop out were unknown reasons ( | PMC9967499 | |
3.2. Adverse Events | EVENTS, DYSFUNCTION | No harmful events occurred during the trial period. However, five events were observed during the data collection that negatively influenced the study procedure, namely, problems with the IMU device, such as not being used, having a low battery, or dysfunction. | PMC9967499 | |
3.3. Within-Group Differences | All three groups improved in functional balance (FBG) (intervention group 1 | PMC9967499 | ||
3.4. Between-Group Differences | There were no differences in changes between baseline and follow-up for any measure ( | PMC9967499 | ||
3.5. Adjustments before the Full RCT | RECRUITMENT | Based on the results from this pilot and feasibility study and from the information obtained at the final workshop with the participating physiotherapists, a number of adjustments are necessary before continuing to a full RCT. To improve the recruitment rate, physiotherapists and occupational therapists at the orthopedic department will inform patients about the study and provide a short, written information sheet before the patient is discharged. Before measuring postural sway with the IMU, the procedure needs to be standardized, with clearer, written instructions provided to the physiotherapists. Postural sway also needs to be measured more frequently during the intervention period to obtain improved information on how postural sway changes over time. Moreover, in order for the physiotherapist to give feedback to the patient, information from the IMU needs to be available in time before the next planned home visit. This is to ensure that the participants receive an update on their training and mobilization. Since not reporting adherence in clinical trials can influence the therapeutic validity of the trial, adherence will also need to be measured in the full RCT [ | PMC9967499 | |
4. Discussion | cognitive impairments, fracture, fractures, loss of mobility and high age | EVENTS, SECONDARY, RECRUITMENT | This pilot study shows that the recruitment rate was considered high, while the collection of primary data was considered high, except for postural sway, which was considered low. The collection of secondary outcomes was considered low. No harmful events were reported. The study also shows that there was no gain in terms of balance, everyday activities, and health-related quality of life after hip fracture for the group randomized to HIFE rehabilitation with or without an IMU compared to the control group. A larger RCT was found to be feasible after the adjustment of outcome data.The postural sway measured with the IMU displayed large variations. This might be due to a number of reasons. The IMU device has shown good reliability compared to a force plate [The recruitment rate was satisfactory (52%), but there may be several reasons for it not being higher. Those who experience hip fractures are often frail with multiple comorbidities, e.g., cognitive impairments, which may affect their ability to participate in the study [The retention rate was 78%, which may be due to the individually tailored interventions. Due to loss of mobility and high age, it is important that interventions after hip fracture meet the individual needs and personal prerequisites required to enhance motivation and, therefore, improve outcome [The decision that a full RCT is feasible to perform was made after discussions in the team concerning the possibilities of adjusting the protocol in a way that recruitment and abilities to collect outcomes at follow-up could be more efficient. In particular, the decision to collect data on postural sway more frequently, together with position and mobility data from the body-worn IMU, may improve the ability to truly individualize rehabilitation. | PMC9967499 |
Strengths and Limitations | Firstly, there were some problems when collecting data on postural sway with the IMU device. The device did not show when it was fully charged, and, therefore, it sometimes turned out to be uncharged at the time of data collection. Moreover, the instructions for standardizing the measuring procedure were not clear enough, which limited our results on postural sway. Moreover, due to the lack of data on compliance rate, we did not know if the intervention groups received more training sessions than the control group or the compliance rate. We did not have information regarding the pre-fracture function of the participants.In this study, we lack qualitative information about how the participants and the PT perceived the intervention. The User Satisfaction Evaluation Questionnaire (USEC) is designed to be answered by a user of technology. In our study, the physiotherapists were the users, but the final workshop with the physiotherapists revealed that they considered USEC to be irrelevant, and, thus, they had not filled it in. Therefore, there were no data from USEC to analyze. We consider the RCT design and the individualized but controlled exercise program as strengths of this study since the program was easy to adjust to each individual’s progression. | PMC9967499 | ||
5. Conclusions | fracture | The results of this pilot and feasibility study show that a full RCT is feasible and can be conducted after adjustments to the protocol. The adjustments include changing to a two-armed RCT, adding two measurements and excluding one, and modifying the instructions and handling of the IMU when measuring postural sway. The result also shows no gain in terms of balance, everyday activities, and health-related quality of life after hip fracture for the group randomized to the HIFE rehabilitation with or without an IMU compared to the control group. | PMC9967499 | |
Author Contributions | Conceptualization, E.E.H., A.M.F. and C.R.; methodology, E.E.H., A.M.F. and C.R.; formal analysis, D.F.H.; data curation, D.F.H.; writing—original draft preparation, D.F.H.; writing—review and editing, D.F.H., E.E.H., A.M.F. and C.R.; supervision, E.E.H.; project administration, E.E.H. All authors have read and agreed to the published version of the manuscript. | PMC9967499 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Swedish Ethical Review Authority (2020-00789, approved 10 June 2020). | PMC9967499 | ||
Informed Consent Statement | Informed consent was obtained from all study participants. Participation was voluntary and did not affect the rehabilitation or other health care treatments. The participants could withdraw at any point and did not have to provide a reason for it. | PMC9967499 | ||
Data Availability Statement | The data used in this study contain sensitive information about the study participants, and they did not provide consent for public data sharing. The current approval by the Swedish Ethical Review Authority does not include data sharing. A minimal data set could be shared on request from a qualified academic investigator for the sole purpose of replicating the present study, provided that the data transfer is in agreement with EU legislation on the general data protection regulation and approval by the Swedish Ethical Review Authority. | PMC9967499 | ||
Conflicts of Interest | The authors declare no conflict of interest, and no external funding was received for the study. | PMC9967499 | ||
References | The inertial measurement unit used in intervention group 2.Flow chart of the study. Reasons for drop out were not known (Categories and examples of HIFE exercises.Intensity scales for HIFE exercises.* Exercise performed close to the limit of postural stability.Median and interquartile range (IQR) for baseline measures for the total group and the total group divided into intervention groups 1 and 2 and the control group.* FBG, Functional Balance for Geriatric Patients; BI, Barthel index; EQ5D index, EuroQol 5-Dimension index; EQ5D VAS, EuroQol 5-Dimension Visual Analogue Scale; PSOEAL, postural sway open eyes anterior/posterior; PSOEML, postural sway open eyes medial/lateral; PSCEAP, postural sway closed eyes anterior/posterior; PSCEML, postural sway closed eyes medial/later.On-treatment analysis of differences in change between baseline and follow-up within groups.CI, 95% confidence interval for median change; On-treatment analysis of differences in changes between baseline and follow-up between groups. Median change and CI between intervention 1 and intervention 2, intervention 1 and control, and intervention 2 and control.CI, 95% confidence interval for median change; | PMC9967499 |
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