Technology-based and Activity-based Design of Mirror Therapy Principles: Two Mixed Reality and Virtual Reality Mirrored-hand Systems for Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change scores of Nottingham Extended Activities of Daily Living scale
研究概览
简要总结
The specific study aims will be:
- To design and develop the hardware and software of the VR+MT and MR+MT systems.
- 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.
- 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.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Virtual Reality-based Mirror Therapy (VR+MT)
In each therapy session, the patients will execute 2 upper-limb functional tasks, starting with easy then more complex tasks.
干预措施: Virtual Reality-based Mirror Therapy (VR+MT) (Behavioral)
Mixed Reality-based Mirror Therapy (MR+MT)
The patients will execute 2 upper-limb functional tasks in each session.
干预措施: Mixed Reality-based Mirror Therapy (MR+MT) (Behavioral)
Traditional Mirror Therapy (MT)
The patients will execute 2 to 3 categories of activities per training session: (1) active range of motion exercises, (2) reaching movement or object manipulation, and (3) upper-limb functional tasks.
干预措施: Traditional Mirror Therapy (MT) (Behavioral)
结局指标
主要结局
Change scores of Nottingham Extended Activities of Daily Living scale
时间窗: baseline, 5 weeks, 9 weeks
The Nottingham Extended Activities of Daily Living scale is an ease-of-use measure with sound reliability and validity to assess independence of more complex daily function. Each item scores ranged from 0 (no/unable) to 3 (on my own/able) with a total score range of 0 to 66. A higher score indicates greater independence of instrumental activities of daily living.
Change scores of Fugl-Meyer Assessment of the Upper Extremity
时间窗: baseline, 5 weeks, 9 weeks
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a measure with sound psychometric properties to evaluate upper-limb hemiparesis of patients following stroke. The total, proximal and distal scores of the FMA-UE range from 0 to 66, from 0 to 42, and from 0 to 24, respectively; a higher score indicates better upper-limb motor function.
次要结局
- Change scores of palmar pinch strengths(baseline, 5 weeks, 9 weeks)
- Change scores of the health state of EQ-5D-5L(baseline, 5 weeks, 9 weeks)
- Change scores of Chedoke Arm and Hand Activity Inventory(baseline, 5 weeks, 9 weeks)
- Change scores of lateral pinch strengths(baseline, 5 weeks, 9 weeks)
- Change scores of grip strengths(baseline, 5 weeks, 9 weeks)
- Change scores of Box and Block Test(baseline, 5 weeks, 9 weeks)
- Change scores of Revised Nottingham Sensory Assessment(baseline, 5 weeks, 9 weeks)
- Change scores of the visual analogue scale of EQ-5D-5L(baseline, 5 weeks, 9 weeks)