Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation
NCT ID: NCT05467813
Last Updated: 2025-06-18
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2022-07-23
2025-12-31
Brief Summary
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Detailed Description
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Current stroke rehabilitation programs, such as mirror therapy and augmented reality and their combination, are novel intervention approaches that have promise for feedback-enhanced stroke rehabilitation. Mirror therapy may contribute to bilateral brain coupling by means of mirror visual feedback. It can potentially be an effective priming technique for creating an enriched neuroplastic environment to facilitate motor and functional recovery. Augmented reality is powered by its potential to provide an intensive, repetitive, and context-rich training program and promote motor, mobility, and cognition function recovery. Mirror therapy and augmented reality can be complementary for formulating a hybrid regimen. Mirror therapy has been implemented conventionally by being based on a bilateral approach. Our innovative protocol will include both unilateral mirror therapy and bilateral mirror therapy using personally relevant task objects for improving task performance. In addition, the investigators will extend clinic-based practice to practice in the home environment by using telehealth techniques for monitoring performance and providing feedback. The goals of this proposed research project will be to examine the effects of the hybrid intervention of mirror therapy preceding augmented reality or conventional therapy on sensory and motor function, mobility, daily function, life quality, and self-efficacy in stroke patients; compare the effects of the hybrid regimen in the clinical versus the home setting; and identify the potential predictors of treatment success using machine learning techniques.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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clinic-setting MT preceding AR-first group
In the experimental group, the participants will receive clinic-based rehabilitation first. After a 3-week washout period, the participants will receive home-based rehabilitation.
mirror therapy
The mirror therapy (MT) will be done with participants seated at a table. The affected upper-extremity (UE) will be placed behind the mirror and the unaffected UE in front of the mirror. Participants will be asked to do the same movements using both the unaffected and affected UE as possible. Each participant will practice two different MT protocols: unilateral mirror therapy (UMT) and bilateral mirror therapy (BMT). During UMT, the affected hand is static, while during BMT, the affected hand moves in an attempt to duplicate the unaffected hand as best as possible. The MT activities include gross motor movements, fine motor movements, and object manipulation.
augmented reality (AR)
The training program provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. To ensure safety, the investigators will place a handrail in front of the participant for support. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg), activities of daily living training (i.e., reaching), and cognitive enhancement (i.e., memory training). By using the AR system, participants can observe the real performance of motions and interaction between the body and the virtual environment.
home-based MT preceding AR-first group
The comparison group will receive home-based rehabilitation first. After a 3-week washout period, the participants will receive clinic-based rehabilitation.
mirror therapy
The mirror therapy (MT) will be done with participants seated at a table. The affected upper-extremity (UE) will be placed behind the mirror and the unaffected UE in front of the mirror. Participants will be asked to do the same movements using both the unaffected and affected UE as possible. Each participant will practice two different MT protocols: unilateral mirror therapy (UMT) and bilateral mirror therapy (BMT). During UMT, the affected hand is static, while during BMT, the affected hand moves in an attempt to duplicate the unaffected hand as best as possible. The MT activities include gross motor movements, fine motor movements, and object manipulation.
augmented reality (AR)
The training program provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. To ensure safety, the investigators will place a handrail in front of the participant for support. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg), activities of daily living training (i.e., reaching), and cognitive enhancement (i.e., memory training). By using the AR system, participants can observe the real performance of motions and interaction between the body and the virtual environment.
conventional therapy in the clinical setting
The control group will receive clinic-based rehabilitation, followed by clinic-based rehabilitative interventions. The participants will practice home-based program on a regular basis.
control therapy
The control intervention will include practice of upper limb activities, balance activities, activities of daily living, and cognitive enhancement tasks. The protocols of the conventional therapy will be formulated by using occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their prioritized goals. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The therapist will work with the participant to select functionally relevant tasks, such as picking up items from a box, lifting soft drink bottles, hanging clothes, and so on.
Interventions
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mirror therapy
The mirror therapy (MT) will be done with participants seated at a table. The affected upper-extremity (UE) will be placed behind the mirror and the unaffected UE in front of the mirror. Participants will be asked to do the same movements using both the unaffected and affected UE as possible. Each participant will practice two different MT protocols: unilateral mirror therapy (UMT) and bilateral mirror therapy (BMT). During UMT, the affected hand is static, while during BMT, the affected hand moves in an attempt to duplicate the unaffected hand as best as possible. The MT activities include gross motor movements, fine motor movements, and object manipulation.
augmented reality (AR)
The training program provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. To ensure safety, the investigators will place a handrail in front of the participant for support. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg), activities of daily living training (i.e., reaching), and cognitive enhancement (i.e., memory training). By using the AR system, participants can observe the real performance of motions and interaction between the body and the virtual environment.
control therapy
The control intervention will include practice of upper limb activities, balance activities, activities of daily living, and cognitive enhancement tasks. The protocols of the conventional therapy will be formulated by using occupational therapy techniques, such as neurodevelopmental techniques and functional task training. The therapy will be adapted to the participants' levels of motor deficits and their prioritized goals. The protocol will include affected arm exercise or gross motor training, muscle strengthening of the affected arm, fine motor or dexterity training, and functional tasks of daily life or compensatory techniques to alleviate functional deficits. The therapist will work with the participant to select functionally relevant tasks, such as picking up items from a box, lifting soft drink bottles, hanging clothes, and so on.
Eligibility Criteria
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Inclusion Criteria
2. age between 20 and 80 years
3. baseline FMA-UE \>10
4. no severe spasticity in any joints of the affected arm MAS \< 3)
5. ability to follow the instructions of the evaluator and therapists (Mini-Mental State Examination Score ≥22)
6. ability to stand in a step-standing position for at least 30 seconds
7. ability to walk a minimum of 10 meters with or without a device
8. no severe vision impairments and other major neurologic diseases
9. ability to take part in a rehabilitation intervention program for 9 weeks
10. not participating in other studies over the study period and willingness to provide informed written consent.
Exclusion Criteria
2. serious medical problems or poor physical conditions that might be detrimental to study participation
20 Years
80 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Keh-Chung Lin, Sc.D
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Locations
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Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
New Taipei City, , Taiwan
Feng Yuan Hospital, Ministry of Health and Welfare
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Hospital, Ministry of Health and Welfare
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Keh-Chung Lin, ScD
Role: primary
Keh-Chung Lin, ScD
Role: primary
Keh-Chung Lin, ScD
Role: primary
Keh-Chung Lin, ScD
Role: primary
Other Identifiers
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202201072RINA
Identifier Type: -
Identifier Source: org_study_id
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