Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games for Rehabilitation Training of Upper Extremity Function in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- Motor function assessed on Fugl-Meyer Assessment (FMA)
研究概览
简要总结
The aims of this study are to (i) develop exergames by using Kinect system for training UE function in patient with stroke; and (ii) to test the game's feasibility and effects in a group of patient with chronic stroke.
详细描述
Exercise based computer games can facilitate high volume complex task practice, enhance feedback of movement and increase motivation of participants. Those effects are difficult to achieve with standard rehabilitation therapy. The Kinect system is a camera-based controller which a player can use to directly control a game through body movement without the need for handheld controllers. Using Kinect to capture movement is a feasible way to help patients who have difficulties to hold controllers to play exergames. Scratch 2.0 is a programming language for kids from the MIT Media Laboratory. It is easy to use for game designing. Kinect2Scratch allows data from the Microsoft Kinect controller to be sent to Scratch, This means that game programs can be designed with motion control. The aims of this study were to i) develop exergames by using Scratch and Kinect system for training upper extremity function in patient with stroke; and ii) to test the game's feasibility and effects in a group of patient with chronic stroke.
This program will be done within two years. During the first year, investigators will design several exergames which are suitable for training upper extremity function in patient with stroke. Investigators will have several experts meetings, involved by physiatrists, occupational therapists and engineers to design the game. When a prototype game is created, investigators will invite two to four patients with stroke to pilot test the game. The game design will be completed till patients and therapists satisfy the design.
During the 2nd year, investigators will test the feasibility and effects of the exergames by doing a pilot randomized control trial. Investigators will recruit 60 patients with chronic stroke who are admitted to a rehabilitation ward for outpatient rehabilitation, and will randomize participants to experiment or control group. All participants will receive PT and OT training as routine. The additional intervention either exergames or conventional OT will be delivered for 8 weeks with 3 training sessions/week of up to 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First ever ischemic or hemorrhagic stroke or former stroke without any significant residual motor impairment
- •3 months post stroke
- •Impaired arm motor function at Brunnstrom stage 3-5
- •Age 18 years or older
排除标准
- •severe cognitive impairment defined as < 20 on Mini Mental State Examination
- •visual disorders or neglect limiting the ability to comply with treatment regimen
- •orthopedic problem or other neurological diagnosis that makes the UE dysfunction.
研究组 & 干预措施
Experimental group
Patients randomized to the experimental group participate in exergames training with Kinect. The supervised OT chooses different games according to the patient's needs and abilities. During therapy patients are at sitting position. The game program will be adjusted when patients got improvement. After 30 minutes of exergames training, participants will receive a 30-minutes of traditional occupational therapy.
干预措施: Kinect (Device)
Experimental group
Patients randomized to the experimental group participate in exergames training with Kinect. The supervised OT chooses different games according to the patient's needs and abilities. During therapy patients are at sitting position. The game program will be adjusted when patients got improvement. After 30 minutes of exergames training, participants will receive a 30-minutes of traditional occupational therapy.
干预措施: Traditional occupational therapy (Behavioral)
Control group
Patients in the control group will receive individually tailored traditional occupational therapy consisting of the similar movement and dose as the experimental group doing by using the traditional equipment, such as climbing bar.
干预措施: Traditional occupational therapy (Behavioral)
结局指标
主要结局
Motor function assessed on Fugl-Meyer Assessment (FMA)
时间窗: Change from baseline at 5 months
The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
次要结局
- The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)(Change from baseline at 5 months)
- Standing balance assessed on The Functional reach test (FR)(Change from baseline at 5 months)
- Muscle power assessed on Medical Research Council Scale (MRC)(Change from baseline at 5 months)
- The amount of movement assessed on Actigraph Assessment(Change from baseline at 2 months)
- The quality of movement and amount of use assessed on Motor Activity Log (MAL)(Change from baseline at 5 months)
- The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)(Change from baseline at 5 months)
- The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)(Change from baseline at 5 months)