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A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial.

ABSTRACT: Background:Family carepartner management and support can improve stroke survivor recovery, yet research has placed little emphasis on how to integrate families into the rehabilitation process without increasing negative carepartner outcomes. Our group has developed creative approaches for engaging family carepartners in rehabilitation activities to improve physical and psychosocial health for both the carepartner and stroke survivor. The purpose of this study is to explore a novel, web-based intervention (Carepartner and Constraint-Induced Therapy; CARE-CITE) designed to facilitate positive carepartner involvement during a home-based application of constraint-induced movement therapy (CIMT) for the upper extremity. Methods:The primary aim of the study is to determine feasibility of CARE-CITE for both stroke survivors and their carepartners. Carepartner mental health, family conflict surrounding stroke recovery, and stroke survivor upper extremity function will be evaluated using an evaluator blinded, two-group experimental design (blocked randomization protocol according to a 2:1 randomization schema) with 32 intervention dyads and 16 control dyads (who will receive CIMT without structured carepartner involvement). CARE-CITE consists of online education modules for the carepartner to review in parallel to the 30-h CIMT that the stroke survivor receives. The intent of CARE-CITE is to enhance the home-based intervention of CIMT, by helping the carepartner support the therapy and create a therapeutic home environment encouraging practice of the weaker arm in functional tasks. Discussion:The CARE-CITE study is testing the feasibility of a family-integrated rehabilitation approach applied in the home environment, and results will provide the foundation for larger clinical studies. The overall significance of this research plan is to increase the understanding and further development of interventions that may serve as models to promote family involvement in the rehabilitation process. Trial registration:ClinicalTrials.gov, NCT02703532. Registered 9 March 2016.

SUBMITTER: Blanton S

PROVIDER: S-EPMC6485162 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial.

Blanton Sarah S Clark Patricia C PC Lyles Robert H RH Cotsonis George G Jones Brian D BD Reiss Aimee A Wolf Steven L SL Dunbar Sandra S

Pilot and feasibility studies 20190425

<h4>Background</h4>Family carepartner management and support can improve stroke survivor recovery, yet research has placed little emphasis on how to integrate families into the rehabilitation process without increasing negative carepartner outcomes. Our group has developed creative approaches for engaging family carepartners in rehabilitation activities to improve physical and psychosocial health for both the carepartner and stroke survivor. The purpose of this study is to explore a novel, web-b ...[more]

PMID: 31057807

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Project description:BackgroundDespite family carepartners of individuals post-stroke experiencing high levels of strain and reduced quality of life, stroke rehabilitation interventions rarely address carepartner well-being or offer training to support their engagement in therapeutic activities. Our group has developed creative intervention approaches to support families during stroke recovery, thereby improving physical and psychosocial outcomes for both carepartners and stroke survivors. The purpose of this study is to test the feasibility of an adapted, home-based intervention (Carepartner Collaborative Integrative Therapy for Gait-CARE-CITE-Gait) designed to facilitate positive carepartner involvement during home-based training targeting gait and mobility.MethodsThis two-phased design will determine the feasibility of CARE-CITE-Gait, a novel intervention that leverages principles from our previous carepartner-focused upper extremity intervention. During the 4-week CARE-CITE-Gait intervention, carepartners review online video-based modules designed to illustrate strategies for an autonomy-supportive environment during functional mobility task practice, and the study team completes two 2-h home visits for dyad collaborative goal setting. In phase I, content validity, usability, and acceptability of the CARE-CITE-Gait modules will be evaluated by stroke rehabilitation content experts and carepartners. In phase II, feasibility (based on measures of recruitment, retention, intervention adherence, and safety) will be measured. Preliminary effects of the CARE-CITE-Gait will be gathered using a single-group, quasi-experimental design with repeated measures (two baseline visits 1 week apart, posttest, and 1-month follow-up) with 15 carepartner and stroke survivor dyads. Outcome data collectors will be blinded. Outcomes include psychosocial variables (family conflict surrounding stroke recovery, strain, autonomy support, and quality of life) collected from carepartners and measures of functional mobility, gait speed, stepping activity, and health-related quality of life collected from stroke survivors.DiscussionThe findings of the feasibility testing and preliminary data on the effects of CARE-CITE-Gait will provide justification and information to guide a future definitive randomized clinical trial. The knowledge gained from this study will enhance our understanding of and aid the development of rehabilitation approaches that address both carepartner and stroke survivor needs during the stroke recovery process.Trial registrationClinicalTrials.gov, NCT05257928. Registered 25 February 2022.Trial statusThis trial was registered on ClinicalTrials.gov (NCT05257928) on March 25, 2022. Recruitment of participants was initiated on May 18, 2022.

Project description:BackgroundUniversity students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support.ObjectiveThe aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students.MethodsThis is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program.ResultsThe trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes.ConclusionsThe acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students.Trial registrationAustralian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291.International registered report identifier (irrid)DERR1-10.2196/21307.

Project description:Objective: It was the aim to assess feasibility, safety, and potential efficacy of a new intensive, focused arm-hand BOOST program and to investigate whether there is a difference between early vs. late delivery of the program in the sub-acute phase post stroke. Methods: In this pilot RCT, patients with stroke were randomized to the immediate group (IG): 4 weeks (4 w) BOOST +4 w CONTROL or the delayed group (DG): 4 w CONTROL +4 w BOOST, on top of their usual inpatient care program. The focused arm-hand BOOST program (1 h/day, 5x/week, 4 weeks) consisted of group exercises with focus on scapula-setting, core-stability, manipulation and complex ADL tasks. Additionally, 1 h per week the Armeo®Power (Hocoma AG, Switzerland) was used. The CONTROL intervention comprised a dose-matched program (24 one-hour sessions in 4 w) of lower limb strengthening exercises and general reconditioning. At baseline, after 4 and 8 weeks of training, the Fugl-Meyer assessment upper extremity (FMA-UE), action research arm test (ARAT), and stroke upper limb capacity scale (SULCS) were administered. Results: Eighteen participants (IG: n = 10, DG: n = 8) were included, with a median (IQR) time post stroke of 8.6 weeks (5-12). No adverse events were experienced. After 4 weeks of training, significant between-group differences were found for FMA-UE (p = 0.003) and SULCS (p = 0.033) and a trend for ARAT (p = 0.075) with median (IQR) change scores for the IG of 9 (7-16), 2 (1-3), and 12.5 (1-18), respectively, and for the DG of 0.5 (-3 to 3), 1 (0-1), and 1.5 (-1 to 9), respectively. In the IG, 80% of patients improved beyond the minimal clinical important difference of FMA-UE after 4 weeks, compared to none of the DG patients. Between 4 and 8 weeks of training, patients in the DG tend to show larger improvements when compared to the IG, however, between-group comparisons did not reach significance. Conclusions: Results of this pilot RCT showed that an intensive, specific arm-hand BOOST program, on top of usual care, is feasible and safe in the sub-acute phase post stroke and suggests positive, clinical meaningful effects on upper limb function, especially when delivered in the early sub-acute phase post stroke. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT04584177.

Project description:IntroductionThe Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.Methods and analysisA 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9 months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.Ethics and disseminationNational Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases.Trial registration numberNCT02429180; Pre-results.

Project description:BackgroundAlmost half of the stroke patients admitted to geriatric rehabilitation has persisting problems after discharge. Currently, there is no evidence based geriatric rehabilitation programme available for older stroke patients, combining inpatient rehabilitation with adequate ambulatory aftercare in the community. Therefore, we developed an integrated multidisciplinary rehabilitation programme that includes aftercare for older persons with stroke. We evaluated the effectiveness of this newly developed rehabilitation programme in comparison to usual care.MethodsA multicentre randomised controlled trial was conducted in eight geriatric rehabilitation stroke units and their collaborating partners in primary care. The study population involved stroke patients and their informal caregivers who were aged 65 or over, living in the community before admission to geriatric rehabilitation, and expected to be able to return home after discharge. The programme consisted of three modules: inpatient neurorehabilitation, home-based self-management training, and stroke education. For patients, daily activity (FAI) was assessed as primary outcome and functional dependence (Katz-15), perceived quality of life (SSQoL) and social participation (IPA) as secondary outcomes. Additionally, among informal caregivers perceived care burden (self-rated burden VAS), objective care burden (Erasmus iBMG), and quality of life (CarerQol), were assessed as secondary outcomes.ResultsIn total 190 patients and 172 informal caregivers were included. Mean age of the patients in the intervention group was 78.9 years (SD = 7.0) and in the usual care group 79.0 years (SD = 6.5). Significant favourable effects for the programme were observed for the subscale autonomy outdoors of the IPA (- 2.15, P = .047, and for the informal caregivers perceived care burden (1.23, P = .048. For the primary outcome daily activity and the other secondary outcomes, no significant effects were observed.ConclusionThe integrated multidisciplinary programme had no effect on daily activity of older stroke patients. However, patients participating in the programme had a higher level of perceived autonomy of outdoor activities and their informal caregivers perceived a lower care burden. The programme might be promising in providing adequate (after) care, although adaptation of the programme is recommended to increase its feasibility and improve its effects.Trial registrationCurrent Controlled Trials ISRCTN62286281 . Registered 19-3-2010.

Project description:Background: Stroke is a leading cause of disability. Nonetheless, the care pathway for stroke rehabilitation takes partially into account the needs of chronic patients. This is due in part to the lack of evidence about the mechanisms of recovery after stroke, together with the poor knowledge of related and influencing factors. Here we report on the study protocol "Rehabilitation and Biomarkers of Stroke Recovery," which consists of 7 work-packages and mainly aim to investigate the effects of long-term neurorehabilitation on stroke patients and to define a related profile of (clinical-biological, imaging, neurophysiological, and genetic-molecular) biomarkers of long-term recovery after stroke. The work-package 1 will represent the main part of this protocol and aims to compare the long-term effects of intensive self-rehabilitation vs. usual (rehabilitation) care for stroke. Methods: We planned to include a total of 134 adult subacute stroke patients (no more than 3 months since onset) suffering from multidomain disability as a consequence of first-ever unilateral ischemic stroke. Eligible participants will be randomly assigned to one of the following groups: intensive self-rehabilitation (based on the principles of "Guided Self-Rehabilitation Contract") vs. usual care (routine practice). Treatment will last 1 year, and patients will be evaluated every 3 months according to their clinical presentation. The following outcomes will be considered in the main work-package: Fugl-Meyer assessment, Cognitive Oxford Screen Barthel Index, structural and functional neuroimaging, cortical excitability, and motor and somatosensory evoked potentials. Discussion: This trial will deal with the effects of an intensive self-management rehabilitation protocol and a related set of biomarkers. It will also investigate the role of training intensity on long-term recovery after stroke. In addition, it will define a set of biomarkers related to post-stroke recovery and neurorehabilitation outcome in order to detect patients with greater potential and define long-term individualized rehabilitation programs. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04323501.

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A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial.

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A web-based carepartner-integrated rehabilitation program for persons with stroke: study protocol for a pilot randomized controlled trial.

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