Clinical trial NCT05903235: Mixed Reality and Virtual Reality Technology With Mirror Therapy for Stroke Rehabilitation
Official title: Technology-based and Activity-based Design of Mirror Therapy Principles: Two Mixed Reality and Virtual Reality Mirrored-hand Systems for Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Cerebrovascular Disorders
Central Nervous System Diseases
Keywords: digital rehabilitation
mixed reality
virtual reality
cerebrovascular accident
mirror visual feedback
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Change scores of Fugl-Meyer Assessment of the Upper Extremity
timeFrame: baseline, 5 weeks, 9 weeks
measure: Change scores of Nottingham Extended Activities of Daily Living scale
timeFrame: baseline, 5 weeks, 9 weeks
Secondary outcomes:
measure: Change scores of grip strengths
timeFrame: baseline, 5 weeks, 9 weeks
measure: Change scores of lateral pinch strengths
timeFrame: baseline, 5 weeks, 9 weeks
measure: Change scores of palmar pinch strengths
timeFrame: baseline, 5 weeks, 9 weeks
measure: Change scores of Box and Block Test
timeFrame: baseline, 5 weeks, 9 weeks
measure: Change scores of Revised Nottingham Sensory Assessment
timeFrame: baseline, 5 weeks, 9 weeks
measure: Change scores of Chedoke Arm and Hand Activity Inventory
timeFrame: baseline, 5 weeks, 9 weeks
measure: Change scores of the health state of EQ-5D-5L
timeFrame: baseline, 5 weeks, 9 weeks
measure: Change scores of the visual analogue scale of EQ-5D-5L
timeFrame: baseline, 5 weeks, 9 weeks
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Occupational Therapy, College of Medicine, Chang Gung University
name: Yu-Wei Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
References: