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Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05903235). StuddyBuddy aggregates publicly available trial information.