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

Overview

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.

Interventions

• 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.
• 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.
• 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.

Primary outcome measures

• Change scores of Fugl-Meyer Assessment of the Upper Extremity [Time frame: baseline, 5 weeks, 9 weeks]
• Change scores of Nottingham Extended Activities of Daily Living scale [Time frame: baseline, 5 weeks, 9 weeks]

Secondary outcome measures (8)

• Change scores of grip strengths [Time frame: baseline, 5 weeks, 9 weeks]
• Change scores of lateral pinch strengths [Time frame: baseline, 5 weeks, 9 weeks]
• Change scores of palmar pinch strengths [Time frame: baseline, 5 weeks, 9 weeks]
• Change scores of Box and Block Test [Time frame: baseline, 5 weeks, 9 weeks]
• Change scores of Revised Nottingham Sensory Assessment [Time frame: baseline, 5 weeks, 9 weeks]
• Change scores of Chedoke Arm and Hand Activity Inventory [Time frame: baseline, 5 weeks, 9 weeks]
• Change scores of the health state of EQ-5D-5L [Time frame: baseline, 5 weeks, 9 weeks]
• Change scores of the visual analogue scale of EQ-5D-5L [Time frame: baseline, 5 weeks, 9 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Taiwan · 1 center

• Taoyuan Chang Gung Memorial Hospital — Taoyuan City

Identifiers

NCT: NCT05903235 · 202201968A3

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗