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

  • STATUS
    Recruiting
  • participants needed
    74
  • sponsor
    Chang Gung Memorial Hospital
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Updated on 19 February 2024
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stroke
aphasia
stroke rehabilitation

Summary

The specific study aims will be:

  1. To develop the novel, digital, and interactive MSR system of arm and hand with integrated digital action observation therapy (AOT) and mirror therapy (MT).
  2. To pilot usability testing for examining the feasibility of this new MSR system from the users' experiences and feedback.
  3. To examine the treatment effects of digital AOT, digital MT and a control intervention in patients with stroke by conducting a randomized controlled trial.
  4. 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 20years - 80years
Treatment Digital Action Observation Therapy (Digital AOT), Digital Mirror Therapy (Digital MT), Conventional Occupational Therapy
Clinical Study IdentifierNCT04441190
SponsorChang Gung Memorial Hospital
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

diagnosed as having a unilateral stroke
aged from 20 to 80 years
a baseline score of the Fugl-Meyer Assessment in a range of 20 to 60
able to follow the instructions and able to provide user feedback verbally
without aphasia and neglect
For therapists
Inclusion Criteria
holding an occupational therapist license
Phase II: Validation of Clinical Treatment Efficacy
Inclusion Criteria
diagnosed as having a unilateral stroke
at least 6 months after stroke onset
aged from 20 to 80 years
a baseline score of FMA in a range of 20 to 60
able to follow the study instructions
capable of participating in therapy and assessment sessions

Exclusion Criteria

global or receptive aphasia
severe neglect
major medical problems or comorbidities that have influenced upper-limb usage or caused severe pain
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