Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy
NCT ID: NCT04441190
Last Updated: 2021-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2020-08-03
2021-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Digital Action Observation Therapy (Digital AOT)
The 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 Action Observation Therapy (Digital AOT)
The participants will be asked to observe videos and then practice what the participants observed.
Digital Mirror Therapy (Digital MT)
The 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)
The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
Conventional Occupational Therapy
The 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
The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.
Interventions
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Digital Action Observation Therapy (Digital AOT)
The participants will be asked to observe videos and then practice what the participants observed.
Digital Mirror Therapy (Digital MT)
The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
Conventional Occupational Therapy
The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* severe neglect,
* major medical problems or comorbidities that have influenced upper-limb usage or caused severe pain
20 Years
80 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Yu-Wei Hsieh, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Occupational Therapy, College of Medicine, Chang Gung University
Locations
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Taipei Hospital, Ministry of Health and Welfare
New Taipei City, , Taiwan
Taoyuan Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Countries
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References
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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.
Other Identifiers
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201901885A3
Identifier Type: -
Identifier Source: org_study_id