RecruitingNot ApplicableNCT05903235

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

Technology-based and Activity-based Design of Mirror Therapy Principles: Two Mixed Reality and Virtual Reality Mirrored-hand Systems for Stroke Rehabilitation

Sponsor

Chang Gung Memorial Hospital

Enrollment

45 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

Central Nervous System Diseases Stroke Cerebrovascular Disorders

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.

Eligibility

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria11

Phase Ⅰ: Design and Development of the VR+MT and MR+MT Systems \& Feasibility Study
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 Criteria7

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

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Interventions

BEHAVIORALVirtual 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.

BEHAVIORALMixed 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.

BEHAVIORALTraditional 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.