Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mirror therapy, augmented reality (AR), control therapy.
- Who it may be relevant to
- Registry conditions: Stroke Rehabilitation. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation: A Cross-Setting Study
Overview
This proposed research is in line with the National Health Research Institutes (NHRI) Innovative Research Grant priority to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that leads to long-term disability and causes a heavy health care and financial burden. To meet multiple needs of patients with stroke, hybrid interventions that combine different approaches and practices in different settings are needed based on the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation. Extending our previous research, the investigators will study the benefits of novel rehabilitation regimens of mirror therapy preceding augmented reality as well as the effects of practice setting (i.e., clinic- vs. home-based settings). In line with the current trend for the development of mirror therapy, mirror therapy will be implemented based on the bilateral and unilateral approach. Augmented reality will be implemented as a means of exergaming with real-time feedback to motivate the patients with stroke for active participation. In addition, telehealth techniques will be used to monitor home practice. This research is innovative in the use of telehealth techniques that will meet the call for therapy outside of the clinical settings in the era of COVID-19 pandemic.
Detailed description
This proposed research is in line with the National Health Research Institutes (NHRI) Innovative Research Grant priority to address innovative treatment strategies for neurological disorders that are in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that leads to long-term disability and causes a heavy health care and financial burden. To meet multiple needs of patients with stroke, hybrid interventions that combine different approaches and practices in different settings are needed based on the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation. Extending our previous research, the investigators will study the benefits of novel rehabilitation regimens of mirror therapy preceding augmented reality as well as the effects of practice setting (i.e., clinic- vs. home-based settings). In line with the current trend for the development of mirror therapy, mirror therapy will be implemented based on the bilateral and unilateral approach. Augmented reality will be implemented as a means of exergaming with real-time feedback to motivate the patients with stroke for active participation. In addition, telehealth techniques will be used to monitor home practice. This research is innovative in the use of telehealth techniques that will meet the call for therapy outside of the clinical settings in the era of COVID-19 pandemic.
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.
Interventions
- Other 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 mo - Other 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 - Other 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,
Primary outcome measures
- Change from Baseline Fugl-Meyer Assessment (FMA) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks. [Time frame: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks]
- Change from Baseline Berg Balance Scale (BBS) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks. [Time frame: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks]
Secondary outcome measures (8)
- Revised Nottingham Sensory Assessment (rNSA) [Time frame: 1,3,6,9,21 weeks]
- Chedoke Arm and Hand Activity Inventory (CAHAI) [Time frame: 1,3,6,9,21 weeks]
- Motor Activity Log (MAL) [Time frame: 1,3,6,9,21 weeks]
- modified Rankin scale [Time frame: 1,3,6,9,21 weeks]
- Stroke Impact Scale Version 3.0 (SIS 3.0) [Time frame: 1,3,6,9,21 weeks]
- Stroke-Specific Measure of Adherence to Home-based Exercises (SS-MAHE) [Time frame: 1,3,6,9,21 weeks]
- Possible Adverse Response [Time frame: through study completion, an average of 21 weeks]
- Montreal Cognitive Assessment [Time frame: 1 and 6 weeks]
Eligibility criteria
Inclusion criteria
- a first-ever unilateral stroke ≥3 months
- age between 20 and 80 years
- baseline FMA-UE >10
- no severe spasticity in any joints of the affected arm MAS < 3)
- ability to follow the instructions of the evaluator and therapists (Mini-Mental State Examination Score ≥22)
- ability to stand in a step-standing position for at least 30 seconds
- ability to walk a minimum of 10 meters with or without a device
- no severe vision impairments and other major neurologic diseases
- ability to take part in a rehabilitation intervention program for 9 weeks
- not participating in other studies over the study period and willingness to provide informed written consent.
Exclusion criteria
- acute inflammation
- serious medical problems or poor physical conditions that might be detrimental to study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 5 centers
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation — New Taipei City
- Feng Yuan Hospital, Ministry of Health and Welfare — Taichung
- National Taiwan University Hospital — Taipei
- Taipei Hospital, Ministry of Health and Welfare — Taipei
- Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation — Taoyuan
Publications
- Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3. PMID 38433459
Identifiers
NCT: NCT05467813 · 202201072RINA