Clinical trial NCT05467813: Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation
Official title: Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation: A Cross-Setting Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Rehabilitation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. a first-ever unilateral stroke ≥3 months
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:

1. acute inflammation
2. serious medical problems or poor physical conditions that might be detrimental to study participation

Primary outcomes:
measure: Change from Baseline Fugl-Meyer Assessment (FMA) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks.
timeFrame: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks
measure: Change from Baseline Berg Balance Scale (BBS) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks.
timeFrame: Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks
Secondary outcomes:
measure: Revised Nottingham Sensory Assessment (rNSA)
timeFrame: 1,3,6,9,21 weeks
measure: Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: 1,3,6,9,21 weeks
measure: Motor Activity Log (MAL)
timeFrame: 1,3,6,9,21 weeks
measure: modified Rankin scale
timeFrame: 1,3,6,9,21 weeks
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: 1,3,6,9,21 weeks
measure: Stroke-Specific Measure of Adherence to Home-based Exercises (SS-MAHE)
timeFrame: 1,3,6,9,21 weeks
measure: Possible Adverse Response
timeFrame: through study completion, an average of 21 weeks
measure: Montreal Cognitive Assessment
timeFrame: 1 and 6 weeks
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
city: Taichung
country: Taiwan
facility: Feng Yuan Hospital, Ministry of Health and Welfare
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
Study officials:
affiliation: National Taiwan University
name: Keh-Chung Lin, Sc.D
role: PRINCIPAL_INVESTIGATOR
References: