Status:
COMPLETED
Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Stroke
Cerebrovascular Disorders
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief 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 p...
Detailed 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 t...
Eligibility Criteria
Inclusion
- Phase I: Multi-mode stroke rehabilitation (MSR) System Development and Usability Testing
- For stroke patients
- 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
- holding an occupational therapist license
- Phase II: Validation of Clinical Treatment Efficacy
- 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
- global or receptive aphasia,
- severe neglect,
- major medical problems or comorbidities that have influenced upper-limb usage or caused severe pain
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04441190
Start Date
August 3 2020
End Date
July 31 2021
Last Update
November 26 2021
Active Locations (2)
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1
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan, 24213
2
Taoyuan Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333