Dataset Information

Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial.

ABSTRACT: Importance:Many patients receive suboptimal rehabilitation therapy doses after stroke owing to limited access to therapists and difficulty with transportation, and their knowledge about stroke is often limited. Telehealth can potentially address these issues. Objectives:To determine whether treatment targeting arm movement delivered via a home-based telerehabilitation (TR) system has comparable efficacy with dose-matched, intensity-matched therapy delivered in a traditional in-clinic (IC) setting, and to examine whether this system has comparable efficacy for providing stroke education. Design, Setting, and Participants:In this randomized, assessor-blinded, noninferiority trial across 11 US sites, 124 patients who had experienced stroke 4 to 36 weeks prior and had arm motor deficits (Fugl-Meyer [FM] score, 22-56 of 66) were enrolled between September 18, 2015, and December 28, 2017, to receive telerehabilitation therapy in the home (TR group) or therapy at an outpatient rehabilitation therapy clinic (IC group). Primary efficacy analysis used the intent-to-treat population. Interventions:Participants received 36 sessions (70 minutes each) of arm motor therapy plus stroke education, with therapy intensity, duration, and frequency matched across groups. Main Outcomes and Measures:Change in FM score from baseline to 4 weeks after end of therapy and change in stroke knowledge from baseline to end of therapy. Results:A total of 124 participants (34 women and 90 men) had a mean (SD) age of 61 (14) years, a mean (SD) baseline FM score of 43 (8) points, and were enrolled a mean (SD) of 18.7 (8.9) weeks after experiencing a stroke. Among those treated, patients in the IC group were adherent to 33.6 of the 36 therapy sessions (93.3%) and patients in the TR group were adherent to 35.4 of the 36 assigned therapy sessions (98.3%). Patients in the IC group had a mean (SD) FM score change of 8.36 (7.04) points from baseline to 30 days after therapy (P?

SUBMITTER: Cramer SC

PROVIDER: S-EPMC6593624 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial.

Cramer Steven C SC Dodakian Lucy L Le Vu V See Jill J Augsburger Renee R McKenzie Alison A Zhou Robert J RJ Chiu Nina L NL Heckhausen Jutta J Cassidy Jessica M JM Scacchi Walt W Smith Megan Therese MT Barrett A M AM Knutson Jayme J Edwards Dylan D Putrino David D Agrawal Kunal K Ngo Kenneth K Roth Elliot J EJ Tirschwell David L DL Woodbury Michelle L ML Zafonte Ross R Zhao Wenle W Spilker Judith J Wolf Steven L SL Broderick Joseph P JP Janis Scott S

JAMA neurology 20190901 9

<h4>Importance</h4>Many patients receive suboptimal rehabilitation therapy doses after stroke owing to limited access to therapists and difficulty with transportation, and their knowledge about stroke is often limited. Telehealth can potentially address these issues.<h4>Objectives</h4>To determine whether treatment targeting arm movement delivered via a home-based telerehabilitation (TR) system has comparable efficacy with dose-matched, intensity-matched therapy delivered in a traditional in-cli ...[more]

PMID: 31233135

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Project description:BackgroundMulticomponent physical exercise programs are a viable strategy for treating physical decline resulting from the aging process in older populations and can be applied in supervised and home-based modalities. However, the magnitude of the intervention effects in terms of physical function development may vary according to the modalities application due to different supervision degrees.ObjectiveThis study aims to compare the effects of supervision in a multicomponent exercise program in different application modalities (supervised vs. home vs. supervised+home) in neuromuscular adaptations, muscle strength, gait, physical function, and quality of life, analyzing the differences between intensity, volume, and density of home and supervised sessions in community older adults.MethodsThis protocol is a randomized controlled clinical trial with a sample of 66 older adults divided into three groups: supervised exercise (SUP = 22), home-based exercise (HB = 22), and supervised plus home-based exercise (SUP+HB = 22). The multicomponent exercise program will last 12 weeks, three times per week, for 60 min per session and include warm-up, balance, muscle-strengthening, gait, and flexibility exercises. The study's primary outcomes will be neuromuscular function, composed of the assessment of muscle isokinetic strength, muscle architecture, and neuromuscular electrical activation. The secondary outcome will be physical function, usual and maximum gait speed with and without dual-task, and quality of life. All outcomes will be assessed at baseline and post-intervention (week 12).ConclusionThis study will be the first clinical trial to examine the effects of different supervision levels on home-based exercises compared to supervised protocols. The results of this study will be essentials for planning coherent and viable home-based programs for older adults.Trial registrationBrazilian Registry of Clinical Trials. Number RBR- 7MZ2KR. https://apps.who.int/trialsearch/Trial2.aspx?TrialID=RBR-7mz2kr.

Project description:Introduction: High doses of activity-based rehabilitation therapy improve outcomes after stroke, but many patients do not receive this for various reasons such as poor access, transportation difficulties, and low compliance. Home-based telerehabilitation (TR) can address these issues. The current study evaluated the feasibility of an expanded TR program. Methods: Under the supervision of a licensed therapist, adults with stroke and limb weakness received home-based TR (1 h/day, 6 days/week) delivered using games and exercises. New features examined include extending therapy to 12 weeks duration, treating both arm and leg motor deficits, patient assessments performed with no therapist supervision, adding sensors to real objects, ingesting a daily experimental (placebo) pill, and generating automated actionable reports. Results: Enrollees (n = 13) were median age 61 (IQR 52-65.5), and 129 (52-486) days post-stroke. Patients initiated therapy on 79.9% of assigned days and completed therapy on 65.7% of days; median therapy dose was 50.4 (33.3-56.7) h. Non-compliance doubled during weeks 7-12. Modified Rankin scores improved in 6/13 patients, 3 of whom were >3 months post-stroke. Fugl-Meyer motor scores increased by 6 (2.5-12.5) points in the arm and 1 (-0.5 to 5) point in the leg. Assessments spanning numerous dimensions of stroke outcomes were successfully implemented; some, including a weekly measure that documented a decline in fatigue (p = 0.004), were successfully scored without therapist supervision. Using data from an attached sensor, real objects could be used to drive game play. The experimental pill was taken on 90.9% of therapy days. Automatic actionable reports reliably notified study personnel when critical values were reached. Conclusions: Several new features performed well, and useful insights were obtained for those that did not. A home-based telehealth system supports a holistic approach to rehabilitation care, including intensive rehabilitation therapy, secondary stroke prevention, screening for complications of stroke, and daily ingestion of a pill. This feasibility study informs future efforts to expand stroke TR. Clinical Trial Registration: Clinicaltrials.gov, # NCT03460587.

Project description:BackgroundThe Tele- Exercise and Multiple Sclerosis (TEAMS) study, funded by the Patient Centered Outcome Research Institute (PCORI), is a pragmatic, cluster randomized controlled trial aimed at comparing the effectiveness of a 12-week complementary and alternative medicine (CAM) program for people with multiple sclerosis (MS) delivered by a therapist at a clinic and the same program initiated by the participant at home using a tablet and pre-recorded videos. The 20-session CAM program consists of yoga, Pilates and dual tasking exercises. The study aimed to enroll 820 participants with MS living in Alabama, Mississippi and Tennessee.Main bodyThe information provided in this paper describes the strategies that led to the largest randomized controlled exercise trial ever conducted for people with multiple sclerosis. Specifically, the paper presents the result of incorporating stakeholder engagement, a novel participant recruitment method, to produce a successful recruitment outcome for a comparative effectiveness randomized controlled trial. This study used three tiers of engagement: panel members (9 members), clinical partners (88 occupational and physical therapists), and community organizations (6 non-profits).ConclusionEngagement of the stakeholder panel, clinical partners and community organizations led to interest of over 1700 people with MS across three states in the Deep South (final enrollment was n = 837). The diversity of our stakeholder groups and their extensive reach into various communities were a critical aspect for achieving our target sample size. The recruitment numbers reflect the importance of involving multiple stakeholder groups at project inception, developing relationships over time, utilizing member strengths, and monitoring their engagement on a regular basis to ensure a meaningful experience for all involved.Trial registrationNCT03117881. Registered 18 April 2017, https://clinicaltrials.gov/ct2/show/NCT03117881?term=tele+rehabilitation&cond=Multiple+Sclerosis&cntry=US&state=US%3AAL&draw=2&rank=1 .

Project description:ImportanceUninterrupted dabigatran therapy reduces stroke risk in patients with nonvalvular atrial fibrillation (NVAF) undergoing ablation and is associated with a lower bleeding risk than uninterrupted warfarin therapy. Minimally interrupted direct oral anticoagulant therapy is widely used, but data from controlled studies are insufficient.ObjectiveTo compare the safety and efficacy of minimally interrupted dabigatran vs uninterrupted warfarin therapy in patients undergoing catheter ablation for NVAF.Design, setting, and participantsThe ABRIDGE-J (ABlation peRIoperative DabiGatran in use Envisioning in Japan) trial is a open-label, randomized clinical trial performed in 28 Japanese treatment centers. A total of 504 patients scheduled for NVAF ablation were enrolled; 500 were randomized to the study treatments; 499 received at least 1 dose of dabigatran etexilate (n = 248) or warfarin potassium (n = 251); and 442 underwent ablation (220 in the dabigatran group and 222 in the warfarin group). Data were collected from May 1, 2014, through September 14, 2015, and analyzed from March 7, 2017, through January 28, 2019.InterventionsAppropriate dose anticoagulation was administered 4 weeks before and at least 3 months after ablation in all patients. Dabigatran therapy was interrupted before catheter ablation (holding of 1-2 doses) and resumed after ablation.Main outcomes and measuresPrimary end points were the incidence of embolism during the perioperative period and atrial thrombus just before the ablation. The main secondary end point was the incidence of major bleeding events until 3 months after ablation.ResultsOf the 442 patients who underwent ablation, 74.9% were men and the median age was 66 years (interquartile range, 59-71 years). Before ablation, 1 cerebral infarction and 1 thrombus in the left atrium occurred in the warfarin group, but no events occurred in the interrupted dabigatran group. After ablation, the mean (SD) incidence of major bleeding events was significantly lower with dabigatran (3 patients [1.4% {0.8%}; 95% CI, 0.4%-4.2%]) vs warfarin (11 patients [5.0% {1.5%}; 95% CI, 2.8%-8.8%]; P = .03). No thromboembolic events occurred after ablation in the dabigatran group; 1 (0.5%) occurred in the warfarin group.Conclusions and relevanceIn patients undergoing ablation for NVAF, anticoagulation with minimally interrupted dabigatran therapy did not increase thromboembolic events and was associated with fewer bleeding complications than uninterrupted warfarin therapy.Trial registrationumin.ac.jp Identifier: UMIN000013129.

Project description:BackgroundStroke survivors constantly feel helpless and unprepared after discharge from hospitals. More flexible and pragmatic support are needed for their optimized recovery. We examined the effects of a virtual multidisciplinary stroke care clinic on survivors' health and self-management outcomes.MethodsA randomized controlled trial was conducted. Survivors were recruited from 10 hospitals and randomized at 1:1 ratio into the intervention or the control groups. Intervention group participants received the Virtual Multidisciplinary Stroke Care Clinic service (monthly online consultations with a nurse, follow-up phone calls, and access to an online platform). Control group participants received the usual care. Outcomes of self-efficacy (stroke self-efficacy questionnaire; primary), self-management behaviors (Stroke Self-Management Behaviors Performance Scale), social participation (reintegration to normal living index), and depression (Geriatric Depression Scale; secondary) were measured at baseline, and 3 and 6 months after commencing the intervention (post-randomization). A generalized estimating equations model was used to compare the differential changes in outcomes at 3 and 6 months with respect to baseline between 2 groups.ResultsBetween July 2019 and June 2022, 335 eligible participants were enrolled in the study. Participants (intervention group; n=166) showed significantly greater improvements in outcomes of self-efficacy (group-by-time interaction regression coefficient, B=4.60 [95% CI, 0.16 to 9.05]), social participation (B=5.07 [95% CI, 0.61 to 9.53]), and depression (B=-2.33 [95% CI, -4.06 to -0.61]), and no significant improvement in performance of self-management behaviors (B=3.45, [95% CI, -0.87 to 7.77]), compared with the control group (n=169) right after the intervention (6 months after its commencement). Hedges' g effect sizes of the intervention on outcomes: 0.19 to 0.36.ConclusionsThe results provide some positive evidence on the usefulness of the Virtual Multidisciplinary Stroke Care Clinic service. The effect sizes are regarded as small to medium, which may not be of clinical relevance. The baseline levels in outcomes were in favor of the control group, the intervention effects might be overestimated. The service must be tested further to determine its effectiveness.RegistrationURL: https://www.chictr.org.cn; Unique identifier: ChiCTR1800016101.

Dataset Information

Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial.

Publications

Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial.

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