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

NCT ID: NCT05903235

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2026-07-31

Brief Summary

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.

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.

Conditions

Stroke; Cerebrovascular Disorders; Central Nervous System Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality-based Mirror Therapy (VR+MT)

Intervention Type: 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.

Mixed Reality-based Mirror Therapy (MR+MT)

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

Group Type: EXPERIMENTAL

Mixed Reality-based Mirror Therapy (MR+MT)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Traditional Mirror Therapy (MT)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

Phase Ⅱ: Validation and Comparison of Clinical Treatment Efficacy

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Wei Hsieh, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Taoyuan Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Wei Hsieh, PhD

Role: CONTACT

ywhsieh@mail.cgu.edu.tw

+886-3-2118800 ext. 3820

Facility Contacts

Yu-Wei Hsieh, PhD

Role: primary

ywhsieh@mail.cgu.edu.tw

+886-3-2118800 ext. 3820

Other Identifiers

202201968A3

Identifier Type: -

Identifier Source: org_study_id