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Actively Recruiting

Every year, about 40,000 people in the Netherlands experience a stroke, and many survivors face challenges with upper limb function, which is important for daily activities. This trial evaluates the effectiveness and cost-effectiveness of continuous theta burst stimulation (cTBS) treatment to improve upper limb recovery in stroke patients admitted to rehabilitation centers. This phase III, multi-center, double-blind, randomized, and sham-controlled clinical trial aims to build on promising phase II results showing significant improvement in arm function and reduced rehabilitation stay. Participants will receive either 10 daily sessions of active cTBS or sham cTBS delivered to the contralesional primary motor cortex within 3 weeks after stroke onset. These sessions are administered over 2 weeks and are given immediately before the patients' regular physical therapy for the affected upper limb. Two groups will be compared: one receiving active cTBS and the other receiving sham cTBS. During the study, researchers will assess upper limb recovery using the Fugl-Meyer Assessment at 90 days post-stroke as the primary outcome. Additional outcomes include arm function tests, stroke impact measures, quality of life, and disability scales at 90 days and one year after stroke. Participants will be closely monitored throughout the study to track their progress and safety, with total participation lasting up to one year after stroke.

Age: 18Years +All GendersPhase Not Applicable
16 locations
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Actively Recruiting

Researchers are evaluating the (cost)effectiveness of the Occupational Therapy at Home E-Rehabilitation (OTHER) intervention compared to usual occupational therapy care in older adults recovering from stroke. The study focuses on community-dwelling persons aged 60 and older in geriatric rehabilitation, aiming to improve self-perceived performance in daily activities, satisfaction with performance, physical activity, and self-management over 26 weeks. It also explores participant and therapist experiences with the intervention and investigates factors affecting its delivery and benefits. The OTHER intervention involves occupational therapists using activity monitoring, coaching, and videoconferencing to support the transition from clinical care to home. Participants receive this treatment over a 24-week period, with assessments at weeks 4, 13, and 26. The study compares this approach to standard occupational therapy to determine differences in outcomes such as daily functioning and quality-adjusted life years. Participants will be involved in regular evaluations including the Canadian Occupational Performance measure at three time points to track changes in daily activity performance. Researchers will monitor treatment fidelity, barriers, facilitators, and cost-effectiveness. The study includes qualitative assessments to understand experiences of stroke survivors and therapists and their reflections on the intervention. Total participation lasts for about 26 weeks with ongoing monitoring.

Age: 60Years +All GendersPhase Not Applicable
9 locations
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