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

NCT05903235 | Recruiting

• 1 other identifier: 202201968A3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The specific study aims will be:

1. 1.To design and develop the hardware and software of the VR+MT and MR+MT systems.
2. 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. 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. 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.

Conditions

Stroke; Cerebrovascular Disorders; Central Nervous System Diseases

Keywords

digital rehabilitation; mixed reality; virtual reality; cerebrovascular accident; mirror visual feedback

Outcome Measures

Primary Outcomes (2)

• Change scores of Fugl-Meyer Assessment of the Upper Extremity

  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

  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 Outcomes (8)

• Change scores of grip strengths

  baseline, 5 weeks, 9 weeks

• Change scores of lateral pinch strengths

  baseline, 5 weeks, 9 weeks

• Change scores of palmar pinch strengths

  baseline, 5 weeks, 9 weeks

• Change scores of Box and Block Test

  baseline, 5 weeks, 9 weeks

• Change scores of Revised Nottingham Sensory Assessment

  baseline, 5 weeks, 9 weeks

Study Arms (3)

Virtual Reality-based Mirror Therapy (VR+MT)

EXPERIMENTAL

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)

Mixed Reality-based Mirror Therapy (MR+MT)

EXPERIMENTAL

The patients will execute 2 upper-limb functional tasks in each session.

Behavioral: Mixed Reality-based Mirror Therapy (MR+MT)

Traditional Mirror Therapy (MT)

ACTIVE COMPARATOR

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)

Interventions

Virtual Reality-based Mirror Therapy (VR+MT) BEHAVIORAL

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.

Virtual Reality-based Mirror Therapy (VR+MT)

Mixed Reality-based Mirror Therapy (MR+MT) BEHAVIORAL

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.

Mixed Reality-based Mirror Therapy (MR+MT)

Traditional Mirror Therapy (MT) BEHAVIORAL

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.

Traditional Mirror Therapy (MT)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Taoyuan Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yu-Wei Hsieh, PhD

  Department of Occupational Therapy, College of Medicine, Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Wei Hsieh, PhD

CONTACT

+886-3-2118800; ywhsieh@mail.cgu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: March 13, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

TW (1)