Mixed Reality and Virtual Reality Technology With Mirror Therapy for Stroke Rehabilitation

March 18, 2026 updated by: Chang Gung Memorial Hospital

Technology-based and Activity-based Design of Mirror Therapy Principles: Two Mixed Reality and Virtual Reality Mirrored-hand Systems for Stroke Rehabilitation

The specific study aims will be:

  1. To design and develop the hardware and software of the VR+MT and MR+MT systems.
  2. To test the feasibility of the VR+MT and MR+MT systems from the patients and to collect the feedback of users with respect to their experiences.
  3. To examine the treatment effects of VR+MT and MR+MT compared to the traditional MT (i.e., control group) in patients with stroke by conducting a randomized controlled trial.
  4. To identify who will be the possible good responders to VR+MT and MR+MT based on their baseline motor functions and mental imagery abilities.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Phase Ⅰ: Design and Development of the VR+MT and MR+MT Systems & Feasibility Study

Sixteen patients with stroke will be recruited in this phase Ⅰ study. During the pilot testing, each stroke patient will use each of the VR+MT and MR+MT systems with the assistance of a researcher holding the occupational therapist certification. The order of the feasibility test of the 2 systems will be counterbalanced across the patients. At the end of the feasibility study of each system, the patients will be asked to complete the System Usability Scale, Virtual Reality Sickness Questionnaire, and a self-designed questionnaire to assess the user experience and perspective about these new systems and their view of its suitability for stroke patients.

Phase Ⅱ: Validation and Comparison of Clinical Treatment Efficacy

This three-arm, single-blind, randomized controlled trial will investigate the treatment effects among the 3 groups of VR+MT, MR+MT, and traditional MT. An estimated 45 patients with stroke will be recruited to participate in this phase Ⅱ study. Each participant will receive a total of 15 training sessions (40 minutes per session) within 5 weeks. Clinical outcome measures will be conducted at baseline, at immediately after treatment, and at 1 month follow-up after treatment.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Taoyuan Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Phase Ⅰ: Design and Development of the VR+MT and MR+MT Systems & Feasibility Study

Inclusion Criteria:

  • diagnosed with unilateral stroke
  • age of 20 to 80 years
  • a baseline Fugl-Meyer Assessment of the Upper Extremity score of 20 to 60
  • able to follow the study instructions and provide the feedback of user experiences verbally

Exclusion Criteria:

  • diagnosed with global or receptive aphasia
  • the presence of severe neglect
  • the existence of major medical problems or comorbidities that could interfere with upper-limb usage and pain, or disrupt visual or auditory perception

Phase Ⅱ: Validation and Comparison of Clinical Treatment Efficacy

Inclusion Criteria:

  • diagnosed with unilateral stroke
  • more than 6 months after stroke onset
  • age of 20 to 80 years
  • a baseline Fugl-Meyer Assessment of the Upper Extremity score of 20 to 60
  • able to follow the study instructions
  • capable of participating in the assessment process and treatment program

Exclusion Criteria:

  • diagnosed with global or receptive aphasia
  • the presence of severe neglect
  • the existence of major medical problems or comorbidities that could interfere with upper-limb usage and pain, or disrupt visual or auditory perception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality-based Mirror Therapy (VR+MT)
In each therapy session, the patients will execute 2 upper-limb functional tasks, starting with easy then more complex tasks.
Behavioral: Virtual Reality-based Mirror Therapy (VR+MT)
In this VR+MT group, the patients will be instructed to perform the unilateral movements of the non-affected upper limb simultaneously while observing the animated hand as mirroring reflection of the affected hand within the immersive environment, which presented on the goggle via the VR+MT system.
Experimental: Mixed Reality-based Mirror Therapy (MR+MT)
The patients will execute 2 upper-limb functional tasks in each session.
Behavioral: Mixed Reality-based Mirror Therapy (MR+MT)
In the MR+MT group, the patients will be instructed to perform the unilateral movements of the non-affected upper limb concurrently meanwhile watching the real-time mirroring image reflection of the non-affected upper limb's movements of the patients captured, transformed, and superimposed on the affected upper limb, which projected to the screen from the front side via the MR+MT system.
Active Comparator: Traditional Mirror Therapy (MT)
The patients will execute 2 to 3 categories of activities per training session: (1) active range of motion exercises, (2) reaching movement or object manipulation, and (3) upper-limb functional tasks.
Behavioral: Traditional Mirror Therapy (MT)
In the traditional MT group, patients will be instructed to perform the unilateral movements of the non-affected upper limb at the same time while watching the mirror of a mirror box placed in front of the patient's midsagittal plane, in which the illusory reflection of the non-affected upper limb appears as if it were the another affected upper limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change scores of Fugl-Meyer Assessment of the Upper Extremity
Time Frame: baseline, 5 weeks, 9 weeks
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a measure with sound psychometric properties to evaluate upper-limb hemiparesis of patients following stroke. The total, proximal and distal scores of the FMA-UE range from 0 to 66, from 0 to 42, and from 0 to 24, respectively; a higher score indicates better upper-limb motor function.
baseline, 5 weeks, 9 weeks
Change scores of Nottingham Extended Activities of Daily Living scale
Time Frame: baseline, 5 weeks, 9 weeks
The Nottingham Extended Activities of Daily Living scale is an ease-of-use measure with sound reliability and validity to assess independence of more complex daily function. Each item scores ranged from 0 (no/unable) to 3 (on my own/able) with a total score range of 0 to 66. A higher score indicates greater independence of instrumental activities of daily living.
baseline, 5 weeks, 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change scores of grip strengths
Time Frame: baseline, 5 weeks, 9 weeks
The Jamar® Plus+ Digital Hand Dynamometer has been designed similarly to the reliable and validated Jamar Hydraulic Hand Dynamometer to measure the grip strength. The grip strengths of both hands were alternatively measured in kilograms (kg) by adopting the average of three measurements.
baseline, 5 weeks, 9 weeks
Change scores of lateral pinch strengths
Time Frame: baseline, 5 weeks, 9 weeks
The Jamar® Plus+ Digital Pinch Gauge has been developed and widely used with the advantages of an easy-to-read digital readout and being capable of storing data. The lateral pinch strengths of both hands will be alternatively measured in kilograms (kg) by adopting the average of three measurements.
baseline, 5 weeks, 9 weeks
Change scores of palmar pinch strengths
Time Frame: baseline, 5 weeks, 9 weeks
The Jamar® Plus+ Digital Pinch Gauge has been developed and widely used with the advantages of an easy-to-read digital readout and being capable of storing data. The palmar pinch strengths of both hands will be alternatively measured in kilograms (kg) by adopting the average of three measurements.
baseline, 5 weeks, 9 weeks
Change scores of the health state of EQ-5D-5L
Time Frame: baseline, 5 weeks, 9 weeks
The questionnaire of EQ-5D-5L comprises 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5-dimension questionnaire represents the health state.
baseline, 5 weeks, 9 weeks
Change scores of the visual analogue scale of EQ-5D-5L
Time Frame: baseline, 5 weeks, 9 weeks
The visual analogue scale of EQ-5D-5L score will be scored from 0 to 100. A higher score indicates better overall current health.
baseline, 5 weeks, 9 weeks
Change scores of Box and Block Test
Time Frame: baseline, 5 weeks, 9 weeks
The Box and Block Test (BBT) is a tool with sound reliability and validity to evaluate hand dexterity. The number of cubes moved represents the BBT score, with a higher score indicating better gross dexterity.
baseline, 5 weeks, 9 weeks
Change scores of Revised Nottingham Sensory Assessment
Time Frame: baseline, 5 weeks, 9 weeks
The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to evaluate sensory function of patients following stroke. The scores of the tactile sensation, proprioception, and stereognosis subscales range from 0 to 108, from 0 to 21, and from 0 to 22, respectively; a higher score indicates better somatosensory function.
baseline, 5 weeks, 9 weeks
Change scores of Chedoke Arm and Hand Activity Inventory
Time Frame: baseline, 5 weeks, 9 weeks
The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to evaluate the independence of patients following stroke to perform activities of daily living with an affected upper limb. Each task scores ranged from 1 (total assist) to 7 (complete independence) with a total score range of 13 to 91. A higher score indicates greater recovery of arm and hand function.
baseline, 5 weeks, 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Yu-Wei Hsieh, PhD, Department of Occupational Therapy, College of Medicine, Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202201968A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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