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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Stroke; Central Nervous System Diseases; Cerebrovascular Disorders

Treatments: Behavioral: Mixed Reality-based Mirror Therapy (MR+MT); Behavioral: Traditional Mirror Therapy (MT); Behavioral: Virtual Reality-based Mirror Therapy (VR+MT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05903235

202201968A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Virtual Reality-based Mirror Therapy (VR+MT)

Experimental group

Description:

In each therapy session, the patients will execute 2 upper-limb functional tasks, starting with easy then more complex tasks.

Treatment:

Behavioral: Virtual Reality-based Mirror Therapy (VR+MT)

Mixed Reality-based Mirror Therapy (MR+MT)

Experimental group

Description:

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

Treatment:

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

Traditional Mirror Therapy (MT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Traditional Mirror Therapy (MT)