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Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy

Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy

Recruiting
20-80 years
All
Phase N/A

Phase I: Multi-mode stroke rehabilitation (MSR) System Development & Usability Testing

Ten patients with stroke and 4 certified occupational therapists were recruited in this phase I study. During the pilot testing, each stroke patient will try to use each training mode of digital AOT and MT by the assistance of the therapist. At the end of the pilot testing, the patients and the therapists will be asked to complete the System Usability Scale and a self-designed questionnaire to assess the user experience and perspective about this new MSR system and their view of its suitability for stroke patients.

Phase II: Validation of Clinical Treatment Efficacy

This three-arm, single-blind, randomized controlled trial will investigate the treatment effects among the 3 groups of digital AOT, digital MT, and dose-matched control intervention. An estimated 60 patients with stroke will be recruited to participate in this phase II study. Each participant will receive a total of 15 training sessions (60 minutes per session) for 3 to 4 weeks. Clinical outcome measures will be conducted at baseline, immediately after treatment (the fourth week), and at 1 month follow-up after treatment.

Study details
    CNS disorder
    Vascular Diseases
    Vascular Diseases
    Cerebrovascular accident
    nervous system disorder
    neurologic disorders
    Cerebrovascular disease
    neurologic disorders

NCT04441190

Chang Gung Memorial Hospital

19 February 2024

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