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Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation

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National Taiwan University

Status

Enrolling

Conditions

Stroke Rehabilitation

Treatments

Other: control therapy
Other: augmented reality (AR)
Other: mirror therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05467813
202201072RINA

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 3 patient groups

clinic-setting MT preceding AR-first group
Experimental group
Description:
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.
Treatment:
Other: mirror therapy
Other: augmented reality (AR)
home-based MT preceding AR-first group
Active Comparator group
Description:
The comparison group will receive home-based rehabilitation first. After a 3-week washout period, the participants will receive clinic-based rehabilitation.
Treatment:
Other: mirror therapy
Other: augmented reality (AR)
clinic-setting MT preceding conventional therapy group
Active Comparator group
Description:
The control group will receive clinic-based rehabilitation first. After a 3-week washout period, the participants will receive clinic-based rehabilitation.
Treatment:
Other: control therapy

Trial contacts and locations

5

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Central trial contact

Keh-Chung Lin, Sc.D

Data sourced from clinicaltrials.gov

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