title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Funding | POLAND | The study was funded by the National Science Centre in Poland under the grant no. 2019/35/N/HS6/04310. | PMC10115883 | |
Data availability | OSF | The data set used in analyses is available at OSF at | PMC10115883 | |
Competing interests | The authors declare no competing interests. | PMC10115883 | ||
References | PMC10115883 | |||
Introduction | acute stroke | ACUTE STROKE | Practicality of implementation and dosing of supplemental gait training in an acute stroke inpatient rehabilitation setting are not well studied but can have positive impact on outcomes. | PMC10552424 |
Objectives | stroke | STROKE | To determine the feasibility of early, intense supplemental gait training in inpatient stroke rehabilitation, compare functional outcomes and the specific mode of delivery. | PMC10552424 |
Design and setting | Assessor blinded, randomized controlled trial in a tertiary Inpatient Rehabilitation Facility. | PMC10552424 | ||
Participants | acute post-stroke, unilateral hemiparesis | Thirty acute post-stroke patients with unilateral hemiparesis (≥ 18 years of age with a lower limb MAS ≤ 3). | PMC10552424 | |
Intervention | Lokomat, ® | Lokomat® or conventional gait training (CGT) in addition to standard mandated therapy time. | PMC10552424 | |
Main outcome measures | PROM | ADVERSE EVENTS | Number of therapy sessions; adverse events; functional independence measure (FIM motor); functional ambulation category (FAC); passive range of motion (PROM); modified Ashworth scale (MAS); 5 times sit-to-stand (5x-STS); 10-m walk test (10MWT); 2-min walk test (2MWT) were assessed before (pre) and after training (post)... | PMC10552424 |
Results | The desired supplemental therapy was implemented during normal care delivery hours and the patients generally tolerated the sessions well. Both groups improved markedly on several measures; the CGT group obtained nearly 45% more | PMC10552424 | ||
Conclusions | With careful planning, supplemental therapy was possible with minimal intrusion to schedules and was well tolerated. Participants showed meaningful functional improvement with relatively little supplemental therapy over a relatively short time in study. | PMC10552424 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12984-023-01243-3. | PMC10552424 | ||
Keywords | PMC10552424 | |||
Introduction | impaired trunk control and gait disability, Stroke | STROKE | Stroke is a major cause of impaired trunk control and gait disability. [It is well established by both animal [ | PMC10552424 |
Methods | PMC10552424 | |||
Study design and randomization | BLIND | This assessor blind, randomized feasibility and pilot study was conducted in a tertiary IRF. The study protocol was approved by the local Institutional Review Board (IRB). Figure Study design overview. Abbreviations used were | PMC10552424 | |
Participants | seizures, stroke, neurological injury or disorder, vascular disorders, fractures, cognitive deficits, lower limb peripheral nerve injury, skin lesions, osteoporosis | STROKE, VASCULAR DISORDERS, PULMONARY DISEASE, SKIN LESIONS, OSTEOPOROSIS | Patients with a recent stroke (on average, less than three weeks post-injury), admitted to an IRF were assessed for eligibility by their treating clinical team (physiatrist and/or physical therapist) between April 2017 and July 2019. Inclusion criteria were: (1) Adult (≥ 18 years of age) after first stroke; (2) able to... | PMC10552424 |
Interventions | Lokomat, ® | Lokomat® or conventional gait training (CGT) was provided in addition to the mandated three hours of conventional IRF therapy. Both groups received up to four 45-min individual gait training sessions per week. Treatment was well defined and standardized at the top level to the degree possible given the individualized n... | PMC10552424 | |
Lokomat® | Lokomat, BWS | The Lokomat® exoskeleton is comprised of two actuated hip and knee leg orthoses that are attached to the participant’s limbs and torso by cuffs and straps. Spring assisted ankle dorsiflexion is implemented via a strap over the shoe. The orthoses, size and position of leg cuffs were measured and adjusted to the particip... | PMC10552424 | |
Conventional | Lokomat® | The conventional gait training (CGT) consisted of therapist assisted and/or use of assistive device (walker) for supported walking, if participants were able, or pre-walking exercises (trunk balance, sitting/standing balance, leg movements, etc.) if participants were not able to walk. In general, therapy was progressed... | PMC10552424 | |
Outcomes | PMC10552424 | |||
Primary outcome measures | ADVERSE EVENTS | Feasibility of implementation, tolerability, number of training sessions completed, serious adverse events (SAEs). | PMC10552424 | |
Secondary outcome measures | PROM | Functional independence measure (FIM) and FIM efficiency, functional ambulatory category (FAC), passive range of motion (PROM), Modified Ashworth Scale (MAS), 10-meter walk test (10MWT), 2-minute walk test (2MWT), 5 Times Sit to Stand (5x-STS) and the Modified Borg Scale were collected to compare outcomes between the t... | PMC10552424 | |
Statistical analysis | The Wilcoxon signed-rank (WSR) test and effect size (Cohen’s d) were used to compare the within group differences in pre- and post-training on the outcome measures. A Bonferroni correction | PMC10552424 | ||
Discussion | Lokomat, stroke | STROKE, STS | It was feasible and well-tolerated to incorporate an additional three hours per week of gait training therapy into all participants’ schedules over a large portion of their inpatient stay. On average, study participants received 11.3 supplemental therapy sessions (12.8 CGT, 9.8 Lokomat®). It has been noted that other a... | PMC10552424 |
Limitations | Study participants were inpatients and subject to many constraints, not the least of which is how long they were able to remain on the inpatient unit. As such, some factors could not be controlled as closely as would have been ideal. The sample size was small but appropriate to determine feasibility of providing supple... | PMC10552424 | ||
Conclusions | PROM, spasticity, stroke, Lokomat, acute stroke | STROKE, ACUTE STROKE | Providing acute stroke patients with additional walking-focused locomotor training is feasible in an IRF environment without undue strain on patient or staff when effort is placed in scheduling such intervention to supplement mandated therapy time. Participants in both intervention groups showed meaningful improvements... | PMC10552424 |
Acknowledgements | We are grateful to all the therapist and participants who carried out the efforts to conduct this study. Stella Lee helped with some data organization, an alternate version of statistical analysis and an initial draft of the manuscript. | PMC10552424 | ||
Author contributions | MT performed statistical analyses, wrote the core version of the manuscript and prepared the manuscript for submission; AE conceived the study, oversaw the implementation of the trial and data collection and assisted with editing the manuscript; both reviewed the final manuscript. | PMC10552424 | ||
Funding | None. | PMC10552424 | ||
Availability of data and materials | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10552424 | ||
Declarations | PMC10552424 | |||
Ethics approval and consent to participate | ALBERT | All study participants freely provided informed consent prior to engaging in any study activities; the IRB of Albert Einstein Healthcare Network approved this study (Reference#4949). | PMC10552424 | |
Consent for publication | Not applicable. | PMC10552424 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10552424 | ||
References | PMC10552424 | |||
Background | disability, LBP, Low back pain | Low back pain (LBP) is the leading cause of years lived with disability worldwide. Public safety workers are highly exposed to physically demanding activities and inappropriate postures, increasing the risk of experiencing LBP. Smartphone app-based self-managed interventions may be an alternative for chronic non-specif... | PMC10693081 | |
Methods | disability, pain | This is a parallel, two-armed, blinded evaluator randomized clinical trial. Police officers and firefighters (from public safety institutions in the Rio Grande do Sul state, Brazil) will be randomly assigned to a m-health self-managed exercise program (twice a week) plus health education or health education alone. Self... | PMC10693081 | |
Discussion | SECONDARY | We hypothesize that the effects of a smartphone app-based self-managed exercise program on co-primary and secondary outcomes will be superior, compared to the health education only in public safety workers with CNSLBP. | PMC10693081 | |
Trial registration | The study was prospectively registered at ClinicalTrials.gov (NCT05481996. Registered on August 01, 2022). | PMC10693081 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07833-9. | PMC10693081 | ||
Keywords | PMC10693081 | |||
Background | LBP, pain, Low back pain, depression, disability | SECONDARY | Low back pain (LBP) is the leading cause of years lived with disability [Several factors can increase the risk of experiencing LBP, including physical (e.g., regular lifting), psychological (e.g., depression), and poor general health (e.g., sleep problems) [The association between subjective (i.e., pain) and objective ... | PMC10693081 |
Methods | PMC10693081 | |||
Protocol elaboration and registration | This study protocol follows the recommendations of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement [ | PMC10693081 | ||
Study design | This study is a prospectively registered, parallel, two-armed, assessor-blinded, superiority randomized controlled trial. Three assessment points were performed (baseline, 8 weeks post-intervention, and 16 weeks follow-up) with probability sampling with randomization in an allocation ratio 1:1. The planned flow diagram... | PMC10693081 | ||
Study setting and eligibility criteria | tumor, Pain, fracture, pain, LBP, NRS | CARDIAC INSUFFICIENCY, TUMOR, CORONARY HEART DISEASE, DISEASES | This trial was conducted until August 2023 at the Inclusion criteria:Aged between 18 and 60 yearsCLBP (defined as pain lasting more than 12 weeks);CLBP of at least three points in a 0 to 10 Pain Numerical Rating Scale (NRS) [Having a smartphone with internet access and an e-mail account;Police officer (federal, federal... | PMC10693081 |
Data collection and management procedures | PMC10693081 | |||
Pre-intervention assessment | After initial contact with researchers, volunteers were scheduled an interview (through a video call) with one of the assessors where the eligibility criteria for participation in the study was checked. Eligible participants received the online consent form via email (see Additional file The baseline, 8-week, and 16-we... | PMC10693081 | ||
Outcome measures | Anxiety, Pain, Isometric muscular endurance, pain, Depression, disability | SECONDARY, CONTRACTION, DECUBITUS | The co-primary outcomes will be pain intensity and disability at 8 weeks (post-treatment). Pain intensity was measured using the 11-point Pain NRS, a numerical scale where 0 indicates no pain and 10 indicates maximum pain intensity, presenting good levels of test–retest reliability intraclass correlation coefficient (I... | PMC10693081 |
Blinding | Due to the intervention’s characteristics, blinding of participants and intervention providers was not possible. The outcome assessors were blinded to the treatment groups. Participants are asked to omit their assigned group and not discuss their interventions during the outcome assessments. In unblinding cases, the pr... | PMC10693081 | ||
Interventions | Intervention descriptions followed the TIDieR (Template for the Intervention Description and Replication) checklist recommendations for telehealth interventions used in clinical trials [ | PMC10693081 | ||
Intervention group: m-health-based pain education and exercise | chronic pain, pain | CHRONIC PAIN | Patients allocated to the experimental group received a login and password for individual access to the smartphone app (The exercise component (app “training” function) included 8 weeks of training, with two sessions per week (non-consecutive days) of core strengthening exercises. The exercise program was developed by ... | PMC10693081 |
Control group: m-health-booklet and pain education | pain | Patients allocated to the control group received a login and password for individual access to the smartphone app designed for the study. The app content for this group included two components: (1) an online booklet and (2) weekly messages. The online booklet contained general information about self-management of CLBP,... | PMC10693081 | |
Strategies for trial retention | Participants allocated to both groups received, in week 4, WhatsApp messages to reinforce the use of the app. There are prohibited concomitant interventions including any systematic or supervised physical exercise to strengthen core (e. g., Pilates, Yoga). Any exercise should be reported by the participants and documen... | PMC10693081 | ||
Statistical methods | PMC10693081 | |||
Sample size calculation | Sample size estimation was performed a priori through G-Power’s statistical software (version 3) [ | PMC10693081 | ||
Data analysis | The baseline characteristics of the participants were calculated using descriptive statistics. The between-group differences and 95% confidence interval (95%IC) for the post-treatment outcomes at 8 weeks and 16 weeks follow-up were calculated using linear mixed models using interaction terms of treatment group versus t... | PMC10693081 | ||
Monitoring | PMC10693081 | |||
Data monitoring and auditing | The study does not have a data monitoring committee either planned auditing trial conduct due to limited resources. We believe this committee would not be mandatory due to the characteristics of interventions and outcomes despite its high value for the overall trial quality. Interim analyses will not be conducted in th... | PMC10693081 | ||
Harms, ancillary, and post-trial care | ADVERSE EVENTS | The adverse events were collected by weekly recording the number of adverse events throughout the intervention period. A closed-ended question with two options (yes or no) sent by the app at the end of each week: “During the last week of the study, did you present any different symptoms or worsening of the initial cond... | PMC10693081 | |
Dissemination policy | EVENT | After completing the study, we aim to disseminate the results to as many stakeholders as possible. First, participants will receive their reports with their measurements and interpretations in language adapted to the lay public’s understanding. The main findings, whether positive, negative, or inconclusive, will be dis... | PMC10693081 | |
Discussion | pain | This randomized control trial will investigate a new model of care to treat a highly prevalent and disabling problem in public safety workers, such as police and firefighters. We hypothesize that the m-health-based telerehabilitation program will benefit public safety workers with CLBP by reducing pain intensity and im... | PMC10693081 | |
Trial status | MAY, RECRUITMENT | The recruitment period for this study occurred from October 2022 to May 2023. This is the first version of the manuscript and is accompanied by a description of existing amendments (see Additional file | PMC10693081 | |
Acknowledgements | Not applicable. | PMC10693081 | ||
Authors’ contributions | DM, TTP | TTP | CLA, EFM, and FBDV designed the study and wrote down the specific aspects of patient-reported outcomes. CLA, EFM, ELC, and FBDV conceptualized the study design. CLA, EFM, ELC, FBDV, and TTP reviewed and edited the draft writing. DM, FS, and TTP developed and supported the application that will be used in this trial. CL... | PMC10693081 |
Funding | The authors of this trial declare that they do not have specific assistance for this research from any funding agency in public, commercial, or non-profit sectors. The principal investigator and the study’s assistant investigators will provide the materials used in this clinical trial. Educational support, such as the ... | PMC10693081 | ||
Availability of data and materials | EVENTS | All data will be used only for analysis of the present study and will be protected from unnecessary exposure. According to the Research Ethics Committee of Physical Education School, the authors and patients will sign the consent form. The paper information will be kept in binders and handled only by the researchers re... | PMC10693081 | |
Declarations | PMC10693081 | |||
Ethics approval and consent to participate | This study was approved by the Research Ethics Committee from | PMC10693081 | ||
Consent for publication | Not applicable. | PMC10693081 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10693081 | ||
References | PMC10693081 | |||
Background/aim | Authors widely use pulse oximetry in clinical monitoring of heart rate (HR) and peripheral oxygen saturation (SpO | PMC10388062 | ||
Materials and methods | burns | We designed a prospective comparative study in a training and research hospital. After local ethical committee approval, pediatric male cases eligible for penile and extremity pulse measurements were evaluated during general anesthesia for medical dressing and/or grafting due to severe burns. One probe was attached to ... | PMC10388062 | |
Results | Data of 51 patients (median age, 2.9 years (interquartile range, 2.0–5.0 years)) in whom the duration of dressing was at least 15 min were analyzed. There was no significant difference either in comparisons of hemodynamic measurements (HR and SpO | PMC10388062 | ||
Conclusion | This clinical trial demonstrated that pulse oximetry measurement under nonhypoxic conditions we could perform confidently using penile probes in pediatric male patients whose extremities are unavailable for measurement. | PMC10388062 | ||
1. Introduction | ’ arterial blood, trauma | PENIS | Arterial blood oxygen saturation (SaO2) has clinical and physiological importance. It is a parameter we must closely monitor in many patients as a direct indicator of oxygen supply to the organs and tissues. SaO2 level can be determined noninvasively by pulse oximetry; this measurement, defined as peripheral oxygen sat... | PMC10388062 |
2. Materials and methods | burn injury, cardiovascular diseases, burn injuries, burns, ’ extremities | ONCOLOGY, PENIS, DISEASE, CARDIOVASCULAR DISEASES | Clinical Research Ethics Committee of Ankara Child Health and Disease, Hematology, Oncology Training, and Research Hospital, Ankara, Turkey (Chairperson Prof. Fatma Demirel) on 01 June 2015 (Approval number: 2015–025) approved the present study. The study was conducted in Ankara Child Health and Disease, Hematology, On... | PMC10388062 |
2.1. Statistical analysis | Data analysis was performed using MedCalc version 11.1.1.0 (MedCalc Software, Mariakerke, Belgium). Where appropriate, data were expressed as mean± SD or median (interquartile range [IQR]). The mean differences in hemodynamic measurements (i.e. HR and SpO | PMC10388062 | ||
3. Results | burns | The study included 56 male pediatric patients with severe burns. There were no race or ethnicity differences. As the medical dressing lasted for 5 min in 2 cases and 10 min in 3 cases, these cases were excluded, and thereby data of 51 patients in whom the duration of dressing was at least 15 min were analyzed. These 51... | PMC10388062 | |
4. Discussion | trauma | PENIS, EVENT | In this study, we aimed to evaluate an alternative side of monitoring to follow up oxygen saturation in certain conditions. Having pulse oximetry results on the extremities might be a problem for burned children. Although the possibility of this situation is slight, it is not negligible. There for, we evaluate the peni... | PMC10388062 |
Acknowledgment | ONCOLOGY, DISEASE | This research did not receive any specific grant or funding from funding agencies in the public, commercial, or not-for-profit sectors.
The authors declare that they have no conflict of interest.
Clinical Research Ethics Committee of Ankara Child Health and Disease, Hematology, Oncology Training, and Research Hospital,... | PMC10388062 | |
References | HEART | Bland-Altman plot showing the magnitude of the difference between heart rate (HR) obtained by penile and finger probes (n = 51). Heart rates unit is beat /minute. Solid lines indicate mean bias and dashed lines indicate the lower and upper limits of agreement. A: 0th (baseline) minute, B: 5th minute, C: 10th minute, an... | PMC10388062 | |
1. Introduction | weight gain, txt4two | txt4two is a multi-modality intervention promoting healthy pregnancy nutrition, physical activity (PA), and gestational weight gain (GWG), which had been previously evaluated in a pilot randomized controlled trial (RCT). This study aimed to evaluate a pragmatic implementation of an adapted version of txt4two in a publi... | PMC9921852 | |
2. Materials and Methods | PMC9921852 | |||
2.1. Study Design | This study followed a consecutive cohort design. It was a prospective, pragmatic implementation and evaluation informed by the RE-AIM framework [ | PMC9921852 | ||
2.2. Participants and Recruitment | RECRUITMENT | This study was delivered through the Brisbane MMH antenatal clinic across 2019–2020. Eligible women were women who entered pregnancy with a BMI ≥ 25 kg/mEligible women were identified through numerous channels, i.e., the MMH online registration form completed by some women attending the publicly-funded antenatal servic... | PMC9921852 | |
2.3. Sample Size | weight gain | Based on detecting the ~2 kg between group difference (+4.3) in weight gain from the pilot RCT [ | PMC9921852 | |
2.4. Intervention—The txt4two Program | The txt4two intervention was delivered from baseline (i.e., between 10 + 0 and 17 + 6 weeks) to 36-weeks’ gestation and consisted of a tailored suite of theoretically grounded, evidence-based intervention strategies focusing on promoting healthy nutrition, physical activity, and GWG. Intervention modalities included: b... | PMC9921852 | ||
2.5. Compensation | Women recruited to the control arm of the study were invited to enter the draw to win one of three Mater Mothers’ product gift packs (AUD 31.98 RRP) at the completion of the baseline and follow-up surveys. Women from the intervention arm were offered the chance to go into the draw to receive one of three AUD 50 departm... | PMC9921852 | ||
2.6. Outcome Measures and Data Analysis | RECRUITMENT | To meet the project aims, a comprehensive evaluation, based on the RE-AIM model, was planned [Implementation/Adoption: Barriers and facilitators to embedding the program into existing services for delivery were interrogated, with examination of study records for timelines and MMH system interactions. Further, senior au... | PMC9921852 | |
2.7. Analysis | Quantitative data were analyzed with IBM SPSS Statistics v28 (Armonk, NY, USA: IBM Corp). Means and standard deviations (normal distributions), medians and interquartile ranges (IQR) (skewed distributions), or frequencies were calculated. The 2009 IOM GWG guidelines [ | PMC9921852 | ||
3. Results | PMC9921852 | |||
3.1. Implementation/Adoption | RECRUITMENT | The program implementation commenced in February 2018 and took two years, as it was impacted by the complexities of navigating the hospital systems and by the COVID-19 pandemic. The adaption and adoption process required many iterations of recruitment processes and program delivery due to extensive consultation and nav... | PMC9921852 | |
3.2. Reach | RECRUITMENT, RECRUITMENT | Recruitment for the prospective control group ran for nine months (29 July 2019–27 April 2020) and for six months for txt4two (8 April 2020–19 October 2020), rather than the planned three months for each. Additional recruitment strategies were added during the study, in response to slow enrolment rates. Women were init... | PMC9921852 | |
3.3. Effectiveness | PMC9921852 | |||
3.3.1. Engagement and Acceptability | Program engagement experiences are outlined in | PMC9921852 | ||
3.3.2. Gestational Weight Gain | As shown in | PMC9921852 |
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