Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy
A Novel, Digital, and Interactive Multi-mode Stroke Rehabilitation System of Arm and Hand: Development and Validation of Clinical Efficacy
1 other identifier
interventional
32
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Aug 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedStudy Start
First participant enrolled
August 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedNovember 26, 2021
June 1, 2020
9 months
June 16, 2020
November 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change scores of Fugl-Meyer Assessment
The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.
baseline, 4 weeks, 2 months
Change scores of Movement Imagery Questionnaire-Revised, Second Edition
The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.
baseline, 4 weeks, 2 months
Secondary Outcomes (9)
Change scores of Chedoke Arm and Hand Activity Inventory
baseline, 4 weeks, 2 months
Change scores of Box and Block Test
baseline, 4 weeks, 2 months
Change scores of Revised Nottingham Sensory Assessment
baseline, 4 weeks, 2 months
Change scores of Barthel Index
baseline, 4 weeks, 2 months
Change scores of Motor Activity Log
baseline, 4 weeks, 2 months
- +4 more secondary outcomes
Study Arms (3)
Digital Action Observation Therapy (Digital AOT)
EXPERIMENTALThe common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.
Digital Mirror Therapy (Digital MT)
EXPERIMENTALThe common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.
Conventional Occupational Therapy
ACTIVE COMPARATORThe common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.
Interventions
The participants will be asked to observe videos and then practice what the participants observed.
The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- global or receptive aphasia,
- severe neglect,
- major medical problems or comorbidities that have influenced upper-limb usage or caused severe pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, 24213, Taiwan
Taoyuan Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
Related Publications (1)
Hsieh YW, Lee MT, Hsu YC, Wu KY, Chen CC. Digital Mirror Therapy and Action Observation Therapy for Chronic Stroke: A Pilot Randomized Controlled Trial. Occup Ther Int. 2025 Mar 20;2025:8741362. doi: 10.1155/oti/8741362. eCollection 2025.
PMID: 40151488DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Wei Hsieh, PhD
Department of Occupational Therapy, College of Medicine, Chang Gung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2020
First Posted
June 22, 2020
Study Start
August 3, 2020
Primary Completion
May 11, 2021
Study Completion
July 31, 2021
Last Updated
November 26, 2021
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share