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Methods for additional analyses (e.g. subgroup analyses) {20b} | stroke, haemorrhagic | STROKE | Subgroup analyses, e.g. based on age (< 65 years, 65–80 years and > 80 years), sex (male and female), stroke severity (NIHSS score; mild, 0–8 moderate, 9–15 and severe, > 15), stroke type (ischaemic vs. haemorrhagic), treatment with tissue plasminogen activator and/or thrombectomy (yes or no) and geographical region, will be conducted as complementary analyses. | PMC10559468 |
Methods in analysis to handle protocol nonadherence and any statistical methods to handle missing data {20c} | All analyses will be conducted in accordance with the intention-to-treat principle. Multiple imputation of missing data will be employed in the primary analysis using multiple imputation by chained equation (MICE) [ | PMC10559468 | ||
Plans to give access to the full protocol, participant-level data and statistical code {31c} | The study protocol, including statistical analyses, will be available in conjunction with the scientific publication. Upon study completion, anonymized data will also be available to the scientific community at large through publications. Moreover, any party may apply to the Chief Investigator for access to the full protocol, deidentified participant-level data and the statistical code for academic research purposes by a study collaboration request. The steering committee will govern data access. | PMC10559468 | ||
Oversight and monitoring | PMC10559468 | |||
Composition of the coordinating centre and trial steering committee {5d} | stroke, TSC | STROKE | The University Hospital of Umeå is the coordinating centre where the Chief Investigator (the first author) and a trial management group (TMG) work. The coordinating centre oversees the fiscal management of the study, ethics approvals, subcontracts with other participating clinics and other financial and oversight responsibilities. The TMG consists of two research nurses, two medical engineers, two RCT coordinators and the Chief Investigator. The TMG provides daily support and troubleshooting to the local participating clinics and has a brief meeting once a week to discuss actual issues.A trial steering committee (TSC) is composed of a national collaboration among four universities and regions in Sweden. The TSC includes an independent chairperson (the last author) and multiple independent members (coauthors), including statisticians, persons with biomedical engineering degrees, rehabilitation and trial experience and patient representatives (nonauthors). TSC responsibilities include clinical setup of the study, ongoing management, study promotion and planning for the interpretation and dissemination of results. TSC meetings were held monthly during the trial planning phase. TSC meetings will take place annually at a minimum to monitor study progress and provide public, clinical information during the active phase. Moreover, professional advice to TMG members will be provided in a timely manner via e-mail or telephone when needed. The TSC will be responsible for reviewing issues and any concerns warranting modification or termination of the study.An advisory board consisting of three professors within the stroke field will provide supervision and feedback on the project annually to the TSC. Together with TSC, this board will ensure that the interpretation of findings is applicable to current practice. | PMC10559468 |
Composition of the data monitoring committee, its role and reporting structure {21a} | The data monitoring committee (DMC) comprises two RCT process controllers who are independent of the study sponsor and funder. The DMC will monitor clinical trial compliance, the completeness of the study data and data safety twice a year, in accordance with the Standard Operating Procedure (SOPs) and Consolidated Standards of Reporting Trials (CONSORT) statement. | PMC10559468 | ||
Adverse event reporting and harms {22} | TSC | ADVERSE EVENTS, ADVERSE EVENT, EVENTS | Even though they are unlikely in this study, adverse events will be immediately reported to the TSC if classified as Related and Unsuspected Serious Adverse Events (RUSAEs), i.e. events that are unexpected in severity and seriousness and suspected to be related to the study intervention. The TSC will then report the case to the DMC with a tailored action plan. | PMC10559468 |
Frequency and plans for auditing trial conduct {23} | To increase the fidelity of the study, the DMC members who are independent of the sponsor will regularly (4 times while participating in the study) notify the participating clinics if there is a breach of protocol or GCP principles that is likely to significantly affect participant safety, health and wellbeing as well as the scientific value of the research. | PMC10559468 | ||
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} | Important protocol amendments will be made by the Chief Investigator following consultation with the TMG and the TSC. All changes to the protocol will be reviewed and approved by the Swedish Ethical Review Authority prior to their implementation. Amendments will then be communicated to research staff and participants by the PI. The major protocol changes will be updated by the Chef Investigator in the clinicaltrials.gov and ISRCTN registry protocol registration within 14 days. | PMC10559468 | ||
Dissemination plans {31a} | Annual trial meetings will be organized for all unit-allied health professionals for exchanging experiences and spreading knowledge. Monthly newsletters and ongoing e-mail contact will also be used to update the study progress and facilitate communication during the study.Upon completion of the trial, investigators will report results, regardless of the direction or magnitude of the effect, through peer-reviewed journal articles, scientific presentations, patient education websites, public media, ClinicalTrials.gov and ISRCTN registry. We endeavour to facilitate knowledge transfer and exchange among different stakeholders. | PMC10559468 | ||
Discussion | ®, Stroke, ’, stroke, Rehabkompassen®, disability | ADVERSE EFFECTS, STROKE, RECRUITMENT, STROKE | Stroke is a leading cause of disability among adults worldwide, with a heavy burden for patients and their families as well as society [To meet these challenges, Rehabkompassen® was recently created and developed as a novel and unique digital follow-up tool to identify and graphically visualize a panoramic view of stroke patients’ heterogeneous rehabilitation needs based on 6 well-validated and reliable PROMs [This two-arm pragmatic multisite study will be able to provide unequivocal results of the eventual effectiveness of the Rehabkompassen tool since both the intervention and control are used in normal practice. Moreover, this trial provides substantial flexibility concerning the adaptation of the Rehabkompassen tool into everyday clinical practice, such as stroke units, early support discharge units and stroke rehabilitation units, in the post-acute continuum of care after stroke in Sweden. A multicentre study also means extra attention should be given to ensure the minimization of the differences and variations among clinics. This is why we will collect baseline data concerning usual care and provide the study information and a training program on the usage of Rehabkompassen® and REDCap prior to patient recruitment. In addition, much information about implementation will be collected from medical practitioners in the participating clinics in the proposed study. Together with the high generalizability of the pragmatic trial [Despite the potential usefulness of the tool, there are various practical and operational issues to consider in this study. We are certainly aware of the major challenge of recruiting more than 1000 patients, which is required for the power analysis. Our pilot study demonstrated a recruitment rate of 28% with a retention rate of 86% at the 12-month follow-up without any severe adverse effects during the heavy pandemic period [We are also aware of the challenge of running such a large multicentre study, especially concerning data collection and management, which is why a separate data management plan has been established and kept at Umeå University. Another issue is technical obstacles for the participants, who are often elderly since the mean age of stroke patients is 73 years old [This study will provide strong evidence on the effectiveness and cost-effectiveness of a novel digital follow-up tool, Rehabkompassen®, in persons discharged from acute care settings after stroke. In addition to improving the tool to be more user -riendly, we envisage finding a cost-effective solution to carry out standard follow-up visits and to facilitate patient-tailored rehabilitation in persons with stroke in current clinical practice. This tool has the potential to improve everyday life for many stroke patients and to reduce the health, social and economic burdens after stroke for patients and their families as well as society. The outcomes of this trial will inform clinical practice and health care policy on the role of the digital follow-up tool Rehabkompassen® in the post-acute continuum of care after stroke. | PMC10559468 |
Trial status | ® | The Rehabkompassen® trial is currently being conducted under version 5.0 of the protocol (2023–06-26. We enrolled our first participant on 2022–02-07. The final participant is scheduled to be enrolled in December 2025 and will complete the study by the end of 2026. | PMC10559468 | |
Acknowledgements | Not applicable. | PMC10559468 | ||
Authors’ contributions {31b} | XH is the Chief Investigator; she conceived the study, led the proposal and protocol development and wrote the first draft of the protocol. XH, KSS, EL, FN, OL, PL and KB contributed to the study design, development of the proposal and securing trial funding. PL is responsible for the statistical analysis, and FN is responsible for the health economic analysis. All the authors have read and approved the final manuscript. | PMC10559468 | ||
Funding {4} | ALF, Stroke | HEART, LUNG, STROKE | Open access funding provided by Umea University. This study is supported by the Swedish Research Council (Grant for clinical studies within therapy research 2022–00316 and Project funding within medicine and health 2022–00746), Forte (2020–00136), the Heart–Lung Foundation (2020676), Västerbotten County Council and Umeå University (ALF Foundation 2022–967513), VINNOVA Medtech4Health (2019–01389) and the Swedish Stroke Foundation (Strokeförbundet). | PMC10559468 |
Availability of data and materials {29} | Key study investigators will have access to the final trial dataset. Trial data will be made available to nonstudy investigators following the approval of a study collaboration request by TSC. | PMC10559468 | ||
Declarations | PMC10559468 | |||
Ethics approval and consent to participate {24} | -20 | The proposed research is a multicentre pragmatic clinical study that includes humans and the handling of personal data. The entire study will be carried out in Sweden. Written, informed consent to participate will be obtained from all participants.Ethical approval and completion of the ethical approval for the proposed multicentre RCT were approved by the Swedish Ethical Review Authority on 2021–04-26 with Dnr 2021–01880 and on 2022–01-26 with Dnr 2021–07010-02. Further ethical approval was granted on 2022–03-26 with Dnr 2022–01503-02, on 2023–01-18 with Dnr 023–00021-02 and on 2023–07-20 with Dnr 2023–03925-02.Clinical trial registration was prospectively performed on 2021–06-04, with the ClinicalTrials.gov identifier NCT04915027. | PMC10559468 | |
Consent for publication {32} | Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request. | PMC10559468 | ||
Competing interests {28} | ® | As the corresponding author, author XH has created the paper version of the tool Rehabkompassen® and owns the registered trademark Rehabkompassen®. Author XH as the main applicant has obtained several Swedish national grants as stated in the Funding {4} above for the development and assessment of the tool.Together with other non-author colleagues, authors XH and OL have developed the tool from the paper version to the digital version and tested the tool in the feasibility study as the basis for this protocol. Authors XH and OL have no financial competing interests.Other authors declare that they have no competing interests. | PMC10559468 | |
References | PMC10559468 | |||
Background | depression | There is increasing evidence that depression can be prevented; however, universal approaches have had limited success. Appropriate targeting of interventions to at-risk populations has been shown to have potential, but how to selectively determine at-risk individuals remains unclear. Workplace stress is a risk factor for depression and a target for intervention, but few interventions exist to prevent depression among workers at risk due to heightened stress. | PMC10485707 | |
Objective | depression | This trial aimed to evaluate the efficacy of a smartphone-based intervention in reducing the onset of depression and improving related outcomes in workers experiencing at least moderate levels of stress. | PMC10485707 | |
Methods | depression | A randomized controlled trial was conducted with participants who were currently employed and reported no clinically significant depression and at least moderate stress. The intervention group (n=1053) were assigned | PMC10485707 | |
Results | depression caseness | There was no significant between-group difference in new depression caseness ( | PMC10485707 | |
Trial Registration | Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000178943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378592 | PMC10485707 | ||
Introduction | PMC10485707 | |||
Background | depressive disorder, MDD, psychiatric | DISEASE, DISORDERS | Major depressive disorder (MDD) is one of the most common psychiatric disorders worldwide and a leading cause of disease burden [To date, most responses to mental health problems, especially work-based interventions, have been reactive, focusing on individuals who are symptomatic or on sick leave [Determining how to target prevention programs is a key consideration. Three types of prevention are commonly encountered: universal, selective, and indicated [Stress has been consistently described as one of the defining health issues of the 21st century [ | PMC10485707 |
Objective | depression | Consequently, we sought to test whether a scalable selective prevention approach to address depression in those affected by workplace stress would be effective. This trial aimed to evaluate the efficacy of a new smartphone app–based intervention in reducing rates of new depression onset, symptomology, and related outcomes compared with an attention-control website condition, in a large sample of workers experiencing elevated levels of stress. To the best of the authors’ knowledge, this is the first time an app-based selective depression prevention program has been evaluated among workers experiencing elevated levels of stress. | PMC10485707 | |
Methods | PMC10485707 | |||
Study Design | A randomized controlled trial was conducted nationally in Australia, with 2 parallel arms comparing an app-based prevention intervention ( | PMC10485707 | ||
Participants | depressed | Participants were required to be aged ≥18 years, currently employed, and an Australian resident. Participants were excluded if they did not own a smartphone or could not understand English. Given the overall aim of this study, it was necessary to recruit a sample of workers who were feeling stressed but not clinically depressed. Therefore, participants were excluded from this study if they reported low stress levels (score <3) on the Single Item Stress Question (SISQ) [ | PMC10485707 | |
Procedures | PMC10485707 | |||
Overview | RECRUITMENT | Participants were recruited using social media advertisements that ran for 27 days from March 2020 to April 2020. Separate recruitment via industry partners had to be abandoned owing to the COVID-19–related economic restrictions. Individuals who clicked a link on the advertisements were taken to a brief study description page on the research institute website and the After consenting, the participants were administered the SISQ as a screening measure. This item measures current stress on a 5-point Likert scale, ranging from 1 (“not at all”) to 5 (“very much”) and has been validated for screening stress levels in a working population [Eligible trial participants created a study account (using email and password) and completed the web-based baseline assessment within their account. Randomization occurred immediately after completion of the assessment. The allocation of participants to the intervention or control condition was concealed using automated procedures integrated into the trial management software. Computer-generated block randomization was used, with a block size of 4, to ensure that equal numbers of participants were assigned to each condition.The intervention group was provided with links to download Participants completed web-based follow-up assessments at 1 month, 3 months, and 6 months after baseline assessment. Web-based assessment platforms were accessed through a unique link provided via text messages and email, with up to 2 reminders per occasion. Participants were allowed up to 2 weeks to complete each assessment. | PMC10485707 | |
Ethics Approval | Ethics approval for this study was obtained from the University of New South Wales Human Research Ethics Committee (HC190914). | PMC10485707 | ||
Informed Consent and Compensation | Participants provided informed consent after being presented with a web-based participant information statement detailing the aspects of data collection, storage, and use; study procedures; benefits and risks of participation; dissemination of results; confidentiality; and withdrawal of consent. Data were deidentified upon collection. Participants were entered into a prize draw to win a gift voucher valued at A$200 (US $140), A$300 (US $210), and A$500 (US $350) on the completion of the 1-, 3-, and 6-month assessments, respectively. | PMC10485707 | ||
Control | The attention-control condition was a health and psychoeducation website ( | PMC10485707 | ||
Outcome Measures | At baseline, demographic information was collected, including age, sex, occupational position and industry, previous help seeking, and prior experience of poor mental health. All outcome measures were administered at baseline and at 1-, 3-, and 6-month postbaseline time points. | PMC10485707 | ||
Primary Outcome | MDD | The primary outcome measure was the incidence of probable MDD aggregated across the follow-up time points. This was measured using the diagnostic algorithm from the PHQ-9 [ | PMC10485707 | |
Secondary Outcomes | Depressive, Anxiety, Work-related burnout, depressive symptoms | Depressive symptoms were measured using the PHQ-9 continuous scoring method, with scores ranging from 0 to 27 and cutoff points of 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe depressive symptoms, respectively [Anxiety symptoms were measured using the General Anxiety Disorder–7 (GAD-7) [Stress was measured using the Perceived Stress Scale [Well-being was measured using the 5-item World Health Organization Well-being Index (WHO-5) [Resilience was measured using the Brief Resilience Scale (BRS), a 6-item measure designed to assess the ability to recover from stress. The BRS has been shown to have good internal consistency and test-retest reliability [Daily life functioning was measured using the Assessment of Quality of Life 4-dimension version (AQoL-4D) [Work-related burnout was assessed using part 2 of the Copenhagen Burnout Inventory (CBI) [Work performance was assessed using the Health and Work Performance Questionnaire [At the 1-month follow-up, a range of questions were administered to elicit participant feedback on the app. Control participants answered the same questions, with wording changed to refer to the study “website” instead of “app.” Several of these questions were adapted from the Mobile Application Rating Scale [App use was measured by collecting the total app use data (combining challenge and toolbox activities). Intervention adherence was recorded as the number of unique challenges completed. | PMC10485707 | |
Data Analysis and Statistical Power | PMC10485707 | |||
Statistical Analyses | Data coding and analyses were carried out by the authors using available software packages including STATA (version 14.2; StataCorp) and SPSS Statistics (version 25.0; IBM Corp). Data on screening, refusals, and dropout were coded and reported according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines (CONSORT (Consolidated Standards of Reporting Trials) flow diagram. | PMC10485707 | ||
Sample Size | As a population-based selective prevention intervention, the effect size of the intervention was anticipated to be relatively small. Analysis of previous | PMC10485707 | ||
Results | PMC10485707 | |||
Primary Outcome—New Depression Caseness | MDD, caseness | REGRESSION | Given the exclusion criteria, no participants met the established PHQ-9 algorithm criteria for a probable diagnosis of MDD at baseline. Mixed effects logistic regression of caseness with postbaseline occasions of measurement and group as crossed factors and a random participant intercept found no overall difference in predicted prevalence of caseness (control: 9.01%, 95% CI 7.11%-10.92%; intervention: 9.95%, 95% CI 8.06%-11.84%; | PMC10485707 |
Secondary Outcomes | PMC10485707 | |||
Other Secondary Outcomes | anxiety | REGRESSION, SECONDARY | There were statistically significant time effects across all time points for most secondary outcomes, showing a regression to the mean. For anxiety symptoms, a significant group-by-time interaction was found at 1-month follow-up ( | PMC10485707 |
App Use | On average, users completed 7.68 (SD 9.26) unique challenges. Although a large portion of the intervention group (518/1053, 49.19%) completed ≤3 challenges, with rates continuing to decline over the full course of the 30-day challenge, 4.84% (51/1053) of the users completed the content in its entirety.Total app use (challenge plus toolbox activities) was notably higher. On average, users completed 10.83 (SD 12.61; range 0-104) activities, with 9.5% (100/1053) completing >30 activities. This indicates that users chose to repeat some challenge activities via the toolbox section. | PMC10485707 | ||
App Feedback | App feedback was received from 468 users: 179 (38.2%) low engagers, 162 (34.6%) medium engagers, and 93 (27.1%) high engagers. The app was well received by respondents, with 81% (379/468) claiming that it had at least moderately improved their mental fitness and only 10.7% (50/468) claiming that they felt no improvement. The majority of the respondents (396/468, 84.6%) claimed that they understood the app content either very well or completely, whereas 91% (426/468) stated that they would recommend the app. Most users found the app design to be at least somewhat interesting or engaging (419/468, 89.5%) and the content at least somewhat interesting or engaging (432/468, 92.3%). Additionally, 77.4% (362/468) found it very or extremely easy to use. Most respondents (321/468, 68.6%) gave the app a 4- or 5-star overall rating.Participants rated cognitive-focused activities (eg, thought challenging) as the most useful (147/466, 31.5%), followed by mindfulness (135/466, 29%), and behavioral activation or goal setting (112/466, 24%). Psychoeducational videos (39/466, 8.4%) and general coping skills activities (eg, exercise, sleep, and socializing; 33/466, 7.1%) had the lowest usefulness ratings. Of those who provided feedback, 43.5% (203/467) claimed to be continuing to use the app, whereas the most common reasons for stopping app use were lack of time (101/467, 21.6%) and lost interest (63/467, 13.5%). A common theme among those who did not complete the intervention was forgetting to use the app. | PMC10485707 | ||
Discussion | PMC10485707 | |||
Principal Findings and Comparison With Prior Work | depression, depressive symptoms | This study evaluated the efficacy of a smartphone app to prevent depression in workers reporting elevated levels of stress. The app did not reduce the incidence of depression, defined as a “case,” but users showed small comparative reductions in depressive symptoms at 1- and 6-month follow-ups. Program adherence was relatively low, with users completing, on average, a quarter of the intervention content. This was potentially impacted by the timing of the study, which occurred during the onset of the COVID-19 crisis in Australia, which may have affected users’ level of commitment. However, when adherence was high, the outcomes showed significant positive changes.A prior uncontrolled pilot study of The ability of the The promising moderation effects of engagement and the significant impact on work performance provide further support for the real-world utility of the app and support findings elsewhere of the small functional impacts of mobile health interventions [ | PMC10485707 | |
Limitations | SECONDARY | The findings of this trial are hampered by low rates of app engagement. The issue of engagement is crucial to digital interventions broadly, presenting a barrier to optimal implementation and necessitating further research. Previous work in this area has highlighted a number of elements that might enhance engagement with workplace digital interventions [A further study limitation was the high dropout rate. Although app feedback was generally positive, it was only received from those completing the postintervention assessment, so it cannot be considered representative of the entire sample. The intervention components seen as most useful were the core CBT elements (thought challenging and behavioral activation), along with mindfulness, whereas the content that focused on improving coping skills through lifestyle change (eg, sleep, alcohol use, relationships, and exercise) was less well received. Encouragingly, this suggests that the formal elements of CBT are viewed by app users as critical even within a prevention framework. An additional limitation was that although the work performance metric was derived from an existing measure and has been used in prior studies, it has not been psychometrically validated; therefore, some caution is recommended in interpreting this secondary outcome.Finally, although the focus was an “at-risk” stressed population, there were high rates of self-reported previous mental ill health, which suggests that the observed evidence of a preventative effect may in fact be—for many users—prevention of relapse. However, as recruiting a sample of working adults with elevated levels of stress with no previously reported mental health concerns would be both impractical and lack real work validity, this is not entirely a shortcoming, and it does not diminish the potential utility of the app, but rather highlights where the interest in such an intervention is likely to reside. Similarly, as with any trial of this kind, there is the potential for a self-selection bias, and thus, the findings may not be representative of all workers. Nevertheless, these tools represent important sources of support for these motivated workers. | PMC10485707 | |
Conclusions | Overall, workers experiencing at least moderate levels of stress who had used the This study was supported by funding from the Australian Government Department of Health through the Prevention Hub. SBH, DAJC, and MD were supported by funding from the iCare Foundation and New South Wales Health. SBH was supported by a National Health and Medical Research Council investigator grant (grant 1178666). The funders of the study had no role in the study design, data collection, data analysis, data interpretation, or writing of the manuscript. The authors would like to acknowledge and thank all the study participants as well as the Black Dog Institute IT and UX Teams for their invaluable contributions to the development and design of the Anchored app. The authors also thank the Centre for Work Health and Safety and other members of the project steering committee for their project guidance. The authors would also like to acknowledge Ms Sophia Mobbs for assisting with this project.Authors' Contributions: SBH and MD conceptualized and designed the study. IL and DAJC contributed to data curation. AM, DAJC, IL, and MD analyzed and interpreted the data. IL, DAJC, and MD contributed to project administration. SBH, NG, RB, HC, and MD supervised the project. MD and DAJC drafted the manuscript. SBH, NG, RB, HC, AM, DAJC, and MD reviewed and edited the manuscript. The corresponding author (MD) had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors have read and approved the final manuscript.Conflicts of Interest: SBH, DAJC, and MD developed the Anchored app but received no financial benefit from it. SBH, DAJC, IL, AM, HC, and MD are employed by the Black Dog Institute, which provides a variety of e-mental health services to various populations.CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) checklist (version 1.6.1). | PMC10485707 | ||
Abbreviations | depressive, Anxiety | Assessment of Quality of Life 4-Dimension VersionBrief Resilience ScaleCopenhagen Burnout Inventorycognitive behavioral therapyConsolidated Standards of Reporting TrialsGeneral Anxiety Disorder-7intention-to-treatmajor depressive disorderPatient Health Questionnaire-9Single Item Stress Question5-item World Health Organization Well-being Index | PMC10485707 | |
Data Availability | The authors confirm that the data supporting the findings of this study are available within the article. If further data are required, reasonable requests in line with ethics approval can be made to the corresponding author (MD). | PMC10485707 | ||
Objective: | stroke | STROKE | To examine the effect of low-frequency acupoint electrical stimulation (LFES) on the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery after stroke. | PMC10681496 |
Methods: | Acupuncture, Stroke | STROKE, DEFICIT | Sixty patients who met the inclusion criteria were randomly assigned to a LFES group or an electroacupuncture (EA) group, with 30 patients in each group. Both groups received conventional treatment, and the EA group was treated with acupoints from the book of Acupuncture and Moxibustion, while the LFES group was treated with acupoints from a previous study. The sEMG characteristic values (maximum value and RMS), Chinese Stroke Clinical Neurological Deficit Scale (CSS), Brunnstrom Motor Function Evaluation, Modified Ashworth Scale (MAS), Lindmark Hand Function Score and Lovett Muscle Strength Classification were measured before and after treatment. | PMC10681496 |
Results: | After treatment, both groups showed improvement in sEMG characteristic values, Brunnstrom motor function score, Lindmark hand function score, and Lovett muscle strength classification compared with before treatment, and the improvement in the LFES group was significantly better than that in the EA group ( | PMC10681496 | ||
Conclusion: | stroke | STROKE | Both LFES and EA were effective in restoring thumb-to-finger movement function after stroke, as evidenced by the increased maximum value and root mean square values of the first dorsal interosseous muscle and the extensor pollicis brevis muscle, the decreased CSS score, the increased Brunnstrom motor function score, the decreased MAS classification, the increased Lindmark hand function score, and the increased Lovett muscle strength classification. However, LFES showed more obvious improvement and better efficacy than EA, which is worthy of clinical promotion. | PMC10681496 |
1. Introduction | neurological deficits, rupture, Stroke, necrosis | HYPOXIC, STROKE, NECROSIS | Stroke is a lesion caused by blockage or rupture of a blood vessel in the brain, resulting in ischemic and hypoxic necrosis of brain tissue, corresponding neurological deficits and consequent symptoms in the dominant area.Thumb-to-finger is one of the basic movements that the hand can complete, and clinically rehabilitate through the opponent’s thumb-to-finger movement to restore certain hand functions. The thumb-to-finger process is actually the pinching process, during which the muscles involved are mainly the first interosseous dorsal muscle and the short thumb extensors, which move in concert to complete the above action. FLES is the application of low-frequency electrical currents to traditional acupuncture points, both to improve the internal state of nerve cells through electrical currents and to regulate the balance of yin and yang, unblock meridians, and promote the flow of qi and blood through acupoint stimulation. | PMC10681496 |
2. Research methodology | PMC10681496 | |||
2.2. Treatment protocol | Acupuncture, cerebrovascular disease, Stroke, → five-finger flexion → wrist dorsal extension | DISEASE, CEREBROVASCULAR DISEASE, STROKE | Patients in both groups received conventional treatment in the acupuncture department, and the Chinese guidelines for primary prevention of cerebrovascular disease in the 2021 edition of the Chinese Multidisciplinary Expert Consensus on Stroke Disease MonitoringEA group treatment: refer to the 13th Five-Year Plan textbook “Acupuncture and Moxibustion”Low frequency group treatment: selected points: Group 1: Shousanli (LI10), Waiguan (SJ5); Group 2: Neiguan (PC6), Ximen (PC4); Group 3: Yuji (LU10), Hegu (LI4). Operation: The patient is seated with the shoulder joint slightly abducted, the elbow joint flexed, the forearm standing sideways on the table, and the hand slightly clenched in a fist. SZR-LF-2A low frequency stimulator and nonwoven electrode patch with the specification of 4 * 4 cm were selected. Routine sterilization of the application site before operation, low-frequency stimulation instrument and electrode patch connected, each group of wires connected to 2 patches, a total of 3 groups, respectively, placed on the selected acupuncture point, the first group of Shousanli, Waiguan, the second group of Neiguan, Ximen, the third group of Yuji, Hegu. The treatment frequency is selected as 50Hz, pulse width 0.3ms, waveform is intermittent waveform, stimulation intensity is tolerated by the patient, the instrument program is set to stimulate the first group of acupoints → second group → first group → third group, forming a set of programmed movements, cyclic operation, appearing alternate movements of flexor and extensor muscles, namely: wrist dorsal extension, five-finger extension → five-finger flexion → wrist dorsal extension, five-finger extension → thumb-index finger pair pinching, simulating fine movements Grasp of the hand, thumb-index finger pair pinch. The treatment course was the same as that of the EA group. The low-frequency treatment process can be seen in Figure Treatment chart of low frequency group. | PMC10681496 |
2.3. Observed indicators | The following subjective and objective indicators were measured before and after treatment in both groups. | PMC10681496 | ||
2.3.1. Objective index measurement. | CONTRACTION | Surface electromyographic eigenvalues: 2 main aspects, maximum value (MAX), and root mean square value (RMS). MAX reflects the maximum contraction strength of the measured muscle. RMS is the root mean square of the EMG transient amplitude over time, which reflects the average change in EMG signal and is therefore used as an evaluation of muscle contraction performance. Surface EMG acquisition is shown in Figure Surface EMG collection. | PMC10681496 | |
2.3.2. Subjective scale collection. | muscle contraction, muscle paralysis | CONTRACTION | ① ② ③ ④ Lindmark hand function score: 0 points: gripping action cannot be completed; 1 point: gripping action can be completed, but cannot resist tiny resistance; 2 points: can hold an object for 5s, but cannot resist medium resistance, or grip is not standard, uncoordinated; 3 points: grip is normal, can hold an object against larger resistance for 5 seconds, and can release the hand like normal people, the total score is 24 points, the higher the score, the The higher the score, the better the hand function.⑤ Lovett muscle strength classification: Grade 0: complete muscle paralysis, palpation muscle completely no contraction; Grade I: slight muscle contraction, but cannot cause joint movement; Grade II: can drive the joint horizontal activity, but cannot fight gravity; Grade III: can fight gravity to do active joint activity, but cannot fight resistance; Grade IV: can fight a larger resistance, but weaker than normal; Grade V: normal muscle strength. | PMC10681496 |
2.4. Clinical efficacy evaluation | Clinical efficacy was assessed using the nimodipine method as a percentage reduction in CSS score: [(pretreatment score − posttreatment score)/pretreatment score] × 100%. Basic healing: reduction rate ≥ 90%; significant improvement: 46%≤ minus rate < 90%; progress: 18% ≤ minus rate < 46%; The ratio of the sum of basic healing, obvious progress, and progress to the sample size of a single group is the total effective rate of the group. | PMC10681496 | ||
2.5. Statistical analysis | ± | SPSS26.0 software was adopted for statistical analysis of the collected data. Count data were tested by 2, and measurement data were expressed as mean ± standard deviation ( | PMC10681496 | |
3. Research results | PMC10681496 | |||
3.1. General information statistics | DISEASE | There were no significant differences between the 2 groups in terms of gender, age and disease duration, which were not statistically significant and comparable. The comparison of gender, age, and course of disease between the 2 groups is shown in Table Comparison of gender age, and duration of disease. | PMC10681496 | |
3.2. Comparison of surface electromyographic characteristic values before and after treatment between 2 groups of patients | PMC10681496 | |||
4. Discussion | upper limb spasm, stroke, hand motor function | STROKE, DISEASE, SEQUELAE, DYSFUNCTION | Thumb-to-finger dysfunction is a difficult point in the treatment of stroke sequelae, affecting upper limb function and grasping ability. In this study, thumb-to-finger dysfunction was mainly due to decreased activation of the extensor and flexor muscles of the fingersThe results showed that the 2 therapies improved the pinching function between the thumb and 2 fingers, the flexion exercise of the interphalangeal joint extension exercise of the thumb, the neurological function defect after stroke, the grading of hand motor function, the degree of upper limb spasm, the muscle strength of the hand, muscle tone, the coordination function between each other and the muscle strength classification of patients after stroke, and the efficacy of the low-frequency group was significantly better than that of the EA group (This study explores the clinical effect of LFES therapy in the treatment of this disease, but there are some shortcomings and prospects. The main problems are: failure to compare and follow up the efficacy of cycles, and the inability to determine the optimal treatment cycle and long-term efficacy; The mechanism was not explored, only clinical efficacy was proved, and the mechanism of action and evaluation of safety and scope of adaptation could not be explained; Trials were conducted only in a single center, with small sample sizes, possible selection bias and regional variation, affecting our confidence in the results. It is recommended to improve the following in the future: regular follow-up of patients to clarify long-term clinical efficacy; Increase the comparison of clinical efficacy of cycles and clarify the optimal treatment cycle; Conduct animal experiments to prove scientific and normative nature, and conduct mechanism discussions; Adopt multi-center, large-sample clinical trials to improve rigor and objectivity; Studies were conducted in different regions and populations to analyze applicability and effectiveness, and to explore differentiation and individualization. | PMC10681496 |
5. Conclusion | Both FLES and EA showed efficacy in the reconstruction of motor function of the thumb-index finger movements, as evidenced by the increase in MAX and RMS values of the first interosseous dorsal muscle and thumb short extensor muscle, the decrease in CSS score, the increase in Brunnstrom motor function score, the decrease in MAS classification, the increase in Lindmark hand function score, and the increase in Lovett muscle strength classification, and the improvement of FLES therapy was more obvious and the efficacy was better than that of EA therapy, which is worthy of clinical promotion. | PMC10681496 | ||
Abbreviations: | stroke, Stroke | STROKE, STROKE | Chinese Stroke Clinical Neurological Deficit Scaleelectroacupuncturelow-frequency acupoint electrical stimulationModified Ashworth Scalemaximum valueroot mean square valueThe authors have no funding and conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.How to cite this article: Xia X, Dong X, Huo H, Zhang Y, Song J, Wang D. Clinical study of low-frequency acupoint electrical stimulation to improve thumb-to-finger movements after stroke: A randomized controlled trial. Medicine 2023;102:47(e35755). | PMC10681496 |
References | PMC10681496 | |||
Background | ATRIAL FIBRILLATION (AF) | Radiofrequency catheter ablation (RFCA) for patients with atrial fibrillation (AF) can generate considerable physical and psychological discomfort under conscious sedation. App-based mindfulness meditation combined with an electroencephalography (EEG)-based brain-computer interface (BCI) shows promise as effective and accessible adjuncts in medical practice. | PMC10193217 | |
Objective | This study aimed to investigate the effectiveness of a BCI-based mindfulness meditation app in improving the experience of patients with AF during RFCA. | PMC10193217 | ||
Methods | pain, Anxiety, Fatigue | ADVERSE EVENTS | This single-center pilot randomized controlled trial involved 84 eligible patients with AF scheduled for RFCA, who were randomized 1:1 to the intervention and control groups. Both groups received a standardized RFCA procedure and a conscious sedative regimen. Patients in the control group were administered conventional care, while those in the intervention group received BCI-based app–delivered mindfulness meditation from a research nurse. The primary outcomes were the changes in the numeric rating scale, State Anxiety Inventory, and Brief Fatigue Inventory scores. Secondary outcomes were the differences in hemodynamic parameters (heart rate, blood pressure, and peripheral oxygen saturation), adverse events, patient-reported pain, and the doses of sedative drugs used in ablation. | PMC10193217 |
Results | BCI-based app–delivered mindfulness meditation, compared to conventional care, resulted in a significantly lower mean numeric rating scale (mean 4.6, SD 1.7 [app-based mindfulness meditation] vs mean 5.7, SD 2.1 [conventional care]; | PMC10193217 | ||
Conclusions | BCI-based app–delivered mindfulness meditation effectively relieved physical and psychological discomfort and may reduce the doses of sedative medication used in RFCA for patients with AF. | PMC10193217 | ||
Trial Registration | NCT05306015 | ClinicalTrials.gov NCT05306015; https://clinicaltrials.gov/ct2/show/NCT05306015 | PMC10193217 | |
Introduction | fatigue, pain, anxiety, cardiac arrhythmia | ADVERSE EVENTS, ATRIAL FIBRILLATION (AF), COMPLICATIONS, CARDIAC ARRHYTHMIA | Atrial fibrillation (AF) is recognized as the most common cardiac arrhythmia worldwide, with an estimated prevalence of 2%-4% in adults [Considering the longer general anesthesia preparation time, higher economic costs, and potential complications, conscious sedation is used for RFCA at most centers in China [Mindfulness meditation originates from Buddhist teachings and refers to a category of techniques used to pay attention to the present moment and accept all that arises without judgment [A brain-computer interface (BCI) is defined as a technology for establishing external information communication and control pathways between the human brain and computers or other electronic devices [This study aimed to determine the effects of a BCI-based mindfulness meditation app on RFCA for patients with AF. The primary hypothesis was that the intervention group would experience significant improvements in perceived pain, anxiety, and fatigue compared to the control group. We also hypothesized that the intervention might decrease the use of sedative drugs and the incidence of adverse events. | PMC10193217 |
Methods | PMC10193217 | |||
Study Design | This was a single-center, 2-arm, parallel-group, prospective, pilot randomized controlled trial. Patients were randomized 1:1 to the intervention and control groups using a computer-generated randomization list. Due to the nature of the study design, neither program implementers nor patients could be blinded to the intervention. However, the investigators performing the outcome assessments and data analysis were blinded to the group allocation. | PMC10193217 | ||
Participants | PMC10193217 | |||
Overview | cognitive complaints, pain | MALIGNANT TUMORS, SYSTEMIC DISEASE | Patients were eligible for the study if they were (1) diagnosed with AF, (2) at least 18 years old, (3) undergoing their initial RFCA procedure, and (4) willing to participate in the study. Patients were excluded if they had (1) severe systemic diseases such as malignant tumors, (2) a history of mental illness and cognitive complaints, and (3) difficulty understanding the questionnaire and the study aims. They were also excluded if they experienced drastic changes in their condition during RFCA.Sample size calculations were conducted using PASS 2021 (NCSS LLC) software and based on previous studies [All patients underwent a standardized RFCA procedure for AF with a 3D mapping system (CARTO 3, Biosense Webster) and were provided with standardized information about the study and the potential benefits and risks of the interventions. Both groups received the same sedative regimen during RFCA, which was adjusted by the interventional physician based on the patient's response to the medication and reported pain levels. The regimen included a single dose of parecoxib (40 mg), fentanyl (1 mcg/kg/hour), and dexmedetomidine as necessary, with dosing adjustments made in accordance with standard pain management procedures at our institution. The fentanyl maintenance infusion rate ranged from 0 to 2 mcg/kg/hour, while the dexmedetomidine maintenance infusion rate ranged from 0 to 1 mcg/kg/hour. | PMC10193217 |
Intervention Group | Patients in the intervention group received mindfulness meditation guidance delivered through a Chinese-language interface and voice app (Focus Zen, version 2.1.1) along with a BCI-based headband. A mobile phone and a Samsung tablet device with the preinstalled app were prepared in the cardiac catheterization laboratory. Before ablation, study staff briefly introduced the method and meaning of mindfulness meditation to help patients understand the intervention content. Mindfulness meditation represents a practice of awareness in which the person gradually and purposefully focuses on the present without judgement to achieve a state of deep relaxation [Screenshots of the study app. (A) Device connection, (B) background sound setting, and (C) mindfulness meditation course). | PMC10193217 | ||
Control Group | pain | The control group received routine care for their ablation procedure and was informed about the procedure of ablation and characteristics of impending pain in ablation, as in the intervention group. Psychological and supportive care were provided in accordance with the patients' needs. However, patients in the control group wore the headband device without using the earphones and did not receive mindfulness meditation guidance provided by the app. | PMC10193217 | |
Outcome Measurements | anxiety, fatigue, pain | Both the intervention and control groups were administered 2 surveys, one 30 minutes before ablation and one within 30 minutes after ablation, to assess pain intensity, fatigue, and anxiety using specific paper questionnaires. Demographic information and characteristics of participants were collected at baseline. The study staff recorded patients' hemodynamic parameters (heart rate, blood pressure, and peripheral oxygen saturation [SpOThe primary outcomes were pain and anxiety levels during ablation and fatigue severity after ablation. The intensity of pain was measured using the numeric rating scale, with scores that ranged from 0 (no pain) to 10 (the worst possible pain) [Secondary outcomes included mean heart rate, blood pressure, and SpO | PMC10193217 | |
Statistical Analysis | Statistical analysis was performed using SPSS (version 22.0; IBM Corp) and based on the intention-to-treat principle with a 2-sided significance level of .05. Data were analyzed using descriptive statistics and checked for the normality of their distribution. Descriptive continuous variables are presented as mean (SD) values and categorical variables as frequency and percentage values. Differences between study groups were analyzed using an independent 2-sample | PMC10193217 | ||
Ethical Considerations | NCT05306015 | This study was conducted at the cardiac catheterization laboratory of the First Affiliated Hospital of Nanjing Medical University, Nanjing, China, from April to September 2022. All study patients provided oral or written informed consent. This study was approved by the ethics committee of the First Affiliated Hospital of Nanjing Medical University (2022-SR-086) and registered at ClinicalTrials.gov (NCT05306015). Procedures were conducted in accordance with the tenets of the Declaration of Helsinki. | PMC10193217 | |
Results | PMC10193217 | |||
Secondary Outcomes | SECONDARY | Between the intervention and control groups in ablation, there were no significant differences in the mean heart rate (mean 87.4, SD 15.7 [intervention group] vs mean 91.1, SD 16.4 [control group] beats per minute; There were no significant differences in parecoxib and dexmedetomidine use between the intervention and control groups during ablation. The intervention group had significantly decreased fentanyl use compared to the control group (Hemodynamic parameters of the 2 groups. bpm: beats per minute; DBP: diastolic blood pressure; HR: heart rate; RFCA: radiofrequency catheter ablation; SBP: systolic blood pressure; SpOComparison of secondary outcomes between the intervention and control groups. | PMC10193217 | |
Discussion | PMC10193217 | |||
Principal Findings | fatigue, anxiety, pain | The purpose of this study was to evaluate the effectiveness of a novel BCI-based mindfulness meditation app for patients with AF to improve their physical and psychological status in RFCA. The selected app provides EEG feedback for mindfulness meditation, which may help patients relax and reduce unpleasant experiences without interfering with the ablation process. The key findings showed significantly lower pain, anxiety, and fatigue scores in the intervention group than among those receiving conventional care. No significant differences were found in the mean heart rate, blood pressure, or SpOMobile health, via wireless technologies such as smartphone apps and wearable devices, is currently used for patients with AF mostly for screening, management, and rehabilitation [It is well known that RFCA for AF can be accompanied by considerable pain and anxiety when conscious sedation is used, which, however, has potential side effects [When patients experience physical and mental discomfort in RFCA, the levels of catecholamines, adrenocorticotropic hormone, prolactin, cortisol, and prostaglandins in their blood may increase [ | PMC10193217 | |
Strengths and Limitations | A strength of this study is that it is the first randomized controlled trial, to our knowledge, to explore the effectiveness of a mindfulness meditation app together with a BCI-based wearable device among patients with AF during RFCA, which adds to the evidence base in the areas of meditation and mobile health. This study was designed rigorously. We provided the same care protocol and implemented the use of wearable devices for both groups, and recorded the time, energy, and temperature of ablation to ensure comparable conditions. In addition, this study was performed in a pragmatic setting and no maximum age for participation was stated, which adds to the generalizability of our findings.This study also has some limitations. First, it was not a double-blind trial. Neither study staff nor patients were blinded to the intervention due to the nature of the study design. However, the data analysts were masked to group allocation. Additionally, meditation practice is a long-term process. Even with the help of apps and wearable devices, it takes time to master meditation techniques to reach a meditative state faster. At least one preoperative practice session could be added to the protocol for the intervention group; however, this might affect the comparability of the baseline measures. Lastly, this is a single-center study, thus limiting the generalizability of our findings. | PMC10193217 | ||
Conclusions | fatigue, ZB, anxiety, pain, GS | ADVERSE EVENTS | In conclusion, this study shows that BCI-based app–delivered mindfulness meditation significantly relieved pain, anxiety, fatigue, and may reduce the doses of sedative medication used during RFCA for AF. Although no significant differences in hemodynamic parameters and the incidence of adverse events were observed, there was a decrease in the incidence of adverse events in the intervention group. Smartphone apps and wearable devices could serve as feasible and promising adjuncts to improve patients with AF’s experience in RFCA.This research was supported by the National Natural Science Foundation of China (72074124), Young Scholars Fostering Fund of the First Affiliated Hospital of Nanjing Medical University (PY2022002), and the Clinical Ability Improvement Project of the First Affiliated Hospital of Nanjing Medical University (JSPH-NC-2021-16).Authors' Contributions: YH and ZB contributed to the development and administration of the project. YH, ZB, ZT, CC, and GY assisted with implementing the protocol, collecting data, performing statistical analyses, and writing the manuscript. ZB and GS contributed to the conceptualization, methodology, supervision, and funding acquisition. All authors provided edits to the manuscript.Conflicts of Interest: None declared.CONSORT-eHEALTH checklist (V 1.6.1). | PMC10193217 |
Abbreviations | Anxiety, Fatigue | atrial fibrillationState Anxiety Inventorybrain-computer interfaceBrief Fatigue InventoryConsolidated Standards of Reporting Trialselectroencephalographyradiofrequency catheter ablationperipheral oxygen saturation | PMC10193217 | |
INTRODUCTION: | intraoperative blood oozing | To compare the effectiveness of the novel hemostatic peptide, TDM-621, with that of conventional hemostatic methods in treating intraoperative blood oozing during endoscopic submucosal dissection (ESD). | PMC9889198 | |
METHODS: | ADVERSE EVENTS, EPITHELIAL TUMORS, SECONDARY | This multicenter, open-label, randomized controlled trial involved 227 patients with gastric and rectal epithelial tumors in whom ESD was indicated. Patients in whom the source of blood oozing was difficult to identify with waterjet washing during the procedure and required hemostasis with hemostatic forceps were randomly assigned to the TDM-621 and control groups. The TDM-621 group (in which hemostasis was achieved with TDM-621, followed by coagulation hemostasis with hemostatic forceps, as needed) was compared with the control group (in which hemostasis was achieved with hemostatic forceps). The primary end point was the mean number of coagulations with hemostatic forceps, determined by a blinded independent review committee. The secondary end points were the rate of achievement of hemostasis with only TDM-621, the dosage of TDM-621, and adverse events in the TDM-621 group. | PMC9889198 | |
RESULTS: | The mean number of coagulations with hemostatic forceps was significantly reduced in the TDM-621 group (1.0 ± 1.4) compared with that in the control group (4.9 ± 5.2) ( | PMC9889198 |
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