Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy
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- STATUS
- Recruiting
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- participants needed
- 74
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- sponsor
- Chang Gung Memorial Hospital
Summary
The specific study aims will be:
- To develop the novel, digital, and interactive MSR system of arm and hand with integrated digital action observation therapy (AOT) and mirror therapy (MT).
- To pilot usability testing for examining the feasibility of this new MSR system from the users' experiences and feedback.
- To examine the treatment effects of digital AOT, digital MT and a control intervention in patients with stroke by conducting a randomized controlled trial.
- To identify who will be the possible good responders to digital AOT and MT based on their baseline motor function and mental imagery abilities.
Description
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.
Details
| Condition | CNS disorder, Vascular Diseases, Vascular Diseases, Cerebrovascular accident, nervous system disorder, neurologic disorders, Cerebrovascular disease, neurologic disorders |
|---|---|
| Age | 20-80 years |
| Treatment | Digital Action Observation Therapy (Digital AOT), Digital Mirror Therapy (Digital MT), Conventional Occupational Therapy |
| Clinical Study Identifier | NCT04441190 |
| Sponsor | Chang Gung Memorial Hospital |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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