Mirror Therapy and Augmented Reality in Stroke Rehabilitation

NCT05993091 | Recruiting DMC

• 1 other identifier: 202303069RINB
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

Brief Summary

This 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 multidimensional needs of patients with stroke, hybrid interventions that combine different approaches are needed due to the complexity of stroke. Our previous research funded by the NHRI has been published and translated to stroke rehabilitation, particularly in the priming and synergic effects of robotic-assisted training and/or mirror therapy (MT). To extend from our previous research, the investigators will combine MT with augmented reality (AR), an emerging adjunct therapy in stroke rehabilitation. An AR-based intervention provides an intensive, repetitive, and context-rich training program, leading to an interesting environment with real-time feedback to increase motivation and participation.

Conditions

Stroke Rehabilitation

Keywords

stroke; rehabilitation; mirror therapy; augemnted reality

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment (FMA)

  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, 6 weeks, and 18 weeks

• Berg Balance Scale (BBS)

  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, 6 weeks, and 18 weeks

Secondary Outcomes (7)

• Revised Nottingham Sensory Assessment (rNSA)

  Baseline, 6 weeks, and 18 weeks

• Chedoke Arm and Hand Activity Inventory (CAHAI)

  Baseline, 6 weeks, and 18 weeks

• Motor Activity Log (MAL)

  Baseline, 6 weeks, and 18 weeks

• Stroke Impact Scale Version 3.0 (SIS 3.0)

  Baseline, 6 weeks, and 18 weeks

• Stroke Self-Efficacy Questionnaire (SSEQ)

  Baseline, 6 weeks, and 18 weeks

Study Arms (3)

MT+AR group

EXPERIMENTAL

The experimental group will receive 40 minutes of MT, followed by 40 minutes of AR training and 10 minutes of functional practice. Figure 2 provides an illustration of the hybrid regimen of MT+AR.

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

AR group

ACTIVE COMPARATOR

The comparison group will receive 80 minutes of AR training combined with 10 minutes of functional practice.

Other: augmented reality (AR)

CT group

ACTIVE COMPARATOR

The control group will receive 90 minutes of conventional occupational therapy, including 10 minutes of functional practice. Examples of functional practice include chopping vegetables, pouring water from a kettle, folding a towel, etc.

Other: Control intervention

Interventions

mirror therapy (MT) OTHER

Each participant will practice two different MT protocols: UMT and BMT. During UMT, the affected hand is static, whereas 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 (i.e., shoulder flexion, elbow flexion/extension, forearm pronation/supination, and wrist flexion/extension and circumduction), fine motor movements (i.e., opposition, grasp, and release), and object manipulation (i.e., reaching out to grasp a cup, flipping coins).

MT+AR group

augmented reality (AR) OTHER

The training program with different levels of difficulty provides goal-directed exercises designed to be adjustable in order to match the patient's ability to minimize compensatory movements. The goal-directed exercise includes balance training (i.e., weight shifting, standing on one leg, etc.), activities of daily living training (i.e., reaching to grasp functionally relevant objects), 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.

AR group; MT+AR group

Control intervention OTHER

Participants will perform 90 minutes of therapist-mediated conventional therapy. The treatment protocols will be formulated by using occupational therapy techniques, such as neurodevelopmental techniques and functional task training. Specifically, the 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 will be used to alleviate functional deficits. In addition, 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.

CT group

Eligibility Criteria

• Age: 30 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 and ≤3 years
• age between 30 and 80 years (Kwakkel et al., 1999)
• baseline Fugl-Meyer Assessment Upper Extremity (FMA-UE) score \>10 (Fugl-Meyer et al., 1975)
• no severe spasticity in any joints of the affected arm (modified Ashworth scale \<3) (Charalambous, 2014)
• ability to follow the instructions of the evaluator and therapists
• the ability to maintain a step-standing position for at least 30 seconds (Lloréns et al., 2015)
• ability to walk a minimum of 10 meters, with or without a device (Park et al., 2017)
• no severe vision impairments or other major neurologic diseases
• no participation in other studies during the study period
• 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 Hospital, Ministry of Health and Welfare

New Taipei City, Taiwan

RECRUITING

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation

New Taipei City, Taiwan

RECRUITING

Fongyuan Hospital, Ministry of Health and Welfare

Taichung, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Wan Fang Hospital, Taipei Medical University

Taipei, Taiwan

RECRUITING

Related Publications (1)

• Lin CJ, Lin KC, Lau HY, Hsieh YW, Li YC, Chen WS, Chen CL, Chang YJ, Lee YY, Yao G, Hrong YS, Pan HC, Wu YH, Hsu WL, Kuo CC, Tsai HT, Lin CY, Chang PC. Effects of mirror therapy preceding augmented reality in stroke rehabilitation: a randomized controlled trial. J Neuroeng Rehabil. 2025 Dec 24;23(1):89. doi: 10.1186/s12984-025-01820-8.

  PMID: 41444616 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Keh-chung Lin, ScD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keh-chung Lin, ScD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study participants and outcome assessors will be blind to group allocation (i.e., experimental, comparative, or control group) of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 15, 2023
• Study Start: May 5, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)