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NCT05903235
Mixed Reality and Virtual Reality Technology With Mirror Therapy for Stroke Rehabilitation
Conditions: Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
Sex: All
Ages: 20 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: Chang Gung Memorial Hospital
Location: Taoyuan Chang Gung Memorial Hospital Taoyuan City
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 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
Source: ClinicalTrials.gov (NCT05903235). StuddyBuddy aggregates publicly available trial information.