Mirror Therapy Preceding Augmented Reality in Stroke Rehabilitation

NCT05467813 | Recruiting

• 1 other identifier: 202201072RINA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Stroke Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Fugl-Meyer Assessment (FMA) at 3 weeks, 6 weeks, 9 weeks, and 21 weeks.

  The upper-extremity subscale of the FMA will be used for the assessment of motor impairment. Movements and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed are scored. Each score is on an ordinal scale of 3 points (0 = cannot perform, 1 = performs partially, 2 = performs fully). The highest score is 66, which indicates optimum recovery. The subscale score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be calculated to study the effects of treatment on separate elements of the upper extremities. The FMA has good reliability, validity, and responsiveness in stroke.

  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.

  The BBS is identified as one of the most widely used evaluation tools of balance across the continuum from acute clinic-based to community-based care. There are 14 items assessing the patient's ability to maintain balance, either statically or with a variety of functional movements, over a given time period. Each score is on a 5-point ordinal scale (0 = inability to complete the task, 4 = independent item completion). The maximum score is 56, representing good balance. The BBS is a reliable and valid tool in assessing balance and functional mobility for stroke.

  Baseline, 3 weeks, 6 weeks, 9 weeks, and 21 weeks

Secondary Outcomes (8)

• Revised Nottingham Sensory Assessment (rNSA)

  1,3,6,9,21 weeks

• Chedoke Arm and Hand Activity Inventory (CAHAI)

  1,3,6,9,21 weeks

• Motor Activity Log (MAL)

  1,3,6,9,21 weeks

• modified Rankin scale

  1,3,6,9,21 weeks

• Stroke Impact Scale Version 3.0 (SIS 3.0)

  1,3,6,9,21 weeks

Study Arms (3)

clinic-setting MT preceding AR-first group

EXPERIMENTAL

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.

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

home-based MT preceding AR-first group

ACTIVE COMPARATOR

The comparison group will receive home-based rehabilitation first. After a 3-week washout period, the participants will receive clinic-based rehabilitation.

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

conventional therapy in the clinical setting

ACTIVE COMPARATOR

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.

Other: control therapy

Interventions

mirror therapy OTHER

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.

clinic-setting MT preceding AR-first group; home-based MT preceding AR-first group

augmented reality (AR) OTHER

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.

clinic-setting MT preceding AR-first group; home-based MT preceding AR-first group

control therapy OTHER

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.

conventional therapy in the clinical setting

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (5)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation

New Taipei City, Taiwan

RECRUITING

Feng Yuan Hospital, Ministry of Health and Welfare

Taichung, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Hospital, Ministry of Health and Welfare

Taipei, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Interventions

Mirror Movement Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Keh-Chung Lin, Sc.D

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keh-Chung Lin, Sc.D

CONTACT

+886-3366-8180; kehchunglin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 21, 2022
• Study Start: July 23, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)