Stroke Clinical Trial - Mixed Reality & Virtual Reality Technology With

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05903235
Study type	Interventional
Source	Chang Gung Memorial Hospital
Contact	Yu-Wei Hsieh, PhD
Phone	+886-3-2118800
Email	ywhsieh@mail.cgu.edu.tw
Status	Not yet recruiting
Phase	N/A
Start date	March 2024
Completion date	July 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms