Mirror Therapy and Augmented Reality in Stroke Rehabilitation

NCT ID: NCT05993091

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2026-12-31

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.

Detailed Description

This proposed research is in line with the prioritized need 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.

Current stroke rehabilitation programs, such as MT and AR and their combination, are novel intervention approaches that have promise for feedback-enhanced stroke rehabilitation. MT 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. AR is powered by its potential to provide an intensive, repetitive, and context-rich training program and promote motor, mobility, and cognition function recovery. MT and AR can be complementary for formulating a hybrid regimen. MT has been implemented conventionally by being based on a bilateral approach. Our innovative protocol will include both unilateral and bilateral MT using personally relevant task objects for improving task performance. The goals of this proposed research project will be to (1) compare treatment efficacy between the hybrid approaches of MT preceding AR (MT+AR), AR-based intervention (AR), and dose-matched conventional therapy (CT) on sensory and motor function, mobility, daily function, life quality, and self-efficacy in stroke patients, and (2) identify the potential predictors of treatment success using chi-squared automatic interaction detection (CHAID). This project is a single-blinded three-armed randomized controlled trial. The investigators plan to recruit 128 stroke survivors who will be randomly allocated to one of the experimental (MT+AR), comparison (AR), or control (CT) groups. The experimental group will receive 40 minutes of MT, followed by 40 minutes of AR training and 10 minutes of functional practice. The comparison group will receive 80 minutes of AR training combined with 10 minutes of functional practice. The control group will have 90 minutes of conventional occupational therapy, including 10 minutes of functional practice.

All participants will receive interventions for 90 minutes/day, 3 days/week for 6 weeks. There will be three assessment time points: baseline, immediately after the intervention, and the 3-month follow-up. The primary outcome measures are the upper-extremity subscale of the Fugl-Meyer Assessment and Berg Balance Scale. Under the International Classification of Functioning, Disability and Health (ICF) framework, the investigators will also include sensory impairment, actual arm use, daily activity function, self-efficacy, and quality of life as the secondary outcomes. Analysis of covariance controlling the baseline scores will be used to analyze the immediate and retention effects between treatment groups. After determining the minimal clinically important difference (MCID) in the primary outcomes using anchor- and distribution-based methods, the investigators will further use CHAID to identify the significant predictors and the corresponding cutoff points to differentiate those who have a greater likelihood to respond to treatment. The investigators expect to provide robust evidence for the hybrid regimen of MT-primed AR to boost poststroke patients' recovery in sensory/motor impairment, dysfunction in daily activities, low self-efficacy, and poor health-related quality of life. Specifically, the priming effect of mirror visual feedback is anticipated to be supported by showing a larger effect size in the MT+AR group compared with the AR and CT group. Based on the clinical trial data of our proposed project, the investigators will determine the MCIDs specific to the outcomes of MT/AR and further conduct the CHAID analysis to identify critical predicting factor of treatment success. The findings will update evidence-based stroke care advocated by the Ministry of Health and Welfare and be used to translate the evidence into clinical practice and decision making in precision stroke rehabilitation.

Conditions

Stroke Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MT+AR group

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.

Group Type: EXPERIMENTAL

mirror therapy (MT)

Intervention Type: 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).

augmented reality (AR)

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

augmented reality (AR)

Intervention Type: 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.

CT group

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.

Group Type: ACTIVE_COMPARATOR

Control intervention

Intervention Type: 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.

Interventions

mirror therapy (MT)

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).

Intervention Type: OTHER

augmented reality (AR)

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.

Intervention Type: OTHER

Control intervention

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. a first-ever unilateral stroke ≥3 months and ≤3 years

2. age between 30 and 80 years (Kwakkel et al., 1999)

3. baseline Fugl-Meyer Assessment Upper Extremity (FMA-UE) score >10 (Fugl-Meyer et al., 1975)

4. no severe spasticity in any joints of the affected arm (modified Ashworth scale <3) (Charalambous, 2014)

5. ability to follow the instructions of the evaluator and therapists

6. the ability to maintain a step-standing position for at least 30 seconds (Lloréns et al., 2015)

7. ability to walk a minimum of 10 meters, with or without a device (Park et al., 2017)

8. no severe vision impairments or other major neurologic diseases

9. no participation in other studies during the study period

10. 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keh-chung Lin, ScD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, , Taiwan

Site Status: RECRUITING

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation

New Taipei City, , Taiwan

Site Status: RECRUITING

Fongyuan Hospital, Ministry of Health and Welfare

Taichung, , Taiwan

Site Status: RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Keh-chung Lin, ScD

Role: CONTACT

kehchunglin@ntu.edu.tw

+886-3366-8180

Facility Contacts

Keh-chung Lin, ScD

Role: primary

kehchunglin@ntu.edu.tw

+886 33668180

Keh-chung Lin, ScD

Role: primary

kehchunglin@ntu.edu.tw

+886-3366-8180

Keh-chung Lin, ScD

Role: primary

kehchunglin@ntu.edu.tw

+886-3366-8180

Keh-chung Lin, ScD

Role: primary

kehchunglin@ntu.edu.tw

+886 33668180

Keh-chung Lin, ScD

Role: primary

kehchunglin@ntu.edu.tw

+886-3366-8180

Other Identifiers

202303069RINB

Identifier Type: -

Identifier Source: org_study_id