The Effects of Virtual Reality Therapy Compared With Home Exercise Program on Upper Extremity Functions in Children With Hemiplegic Cerebral Palsy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Assisting Hand Assessment (AHA)
研究概览
简要总结
The investigators have planned a research on the effects of virtual reality therapy and home exercise program on hand functions in children with hemiplegic cerebral palsy in Istanbul University Istanbul Faculty of Medicine in the Department of Physical Medicine and Rehabilitation. The eligible patients will be randomized into two groups. The patients in intervention group will participate in a computer based virtual reality exercise program for a period of 8 weeks supervised by the investigators. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. All patients will be evaluated before treatment, immediately after treatment, and 3 months after the end of the treatment.
详细描述
The current study is a prospective, randomized controlled interventional trial, which will conduct in the Istanbul University Istanbul Faculty of Medicine in 2016. The study was approved by the Ethics Committee in conformity with the Declaration of Helsinki. Prior to data collection, all participants will provide informed consent. By the order of application to the outpatient clinics, the eligible participants will randomly allocated to two groups using the computer-generated random numbers: intervention group (n=17) and control group (n=17). Information on demographic characteristics (age, gender, body mass index, educational level), pre-natal history, parent educational level and past medical history will obtain at baseline assessment. After baseline assessment, the patients in intervention group will participate in a computer based virtual reality exercise program with HandTutor equipment. The supervised intervention program consists of a forty-minute exercise session three times a week for 8 weeks. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. The home exercise program consists of different games and exercises such as range of motion, stretch, and strengthening exercises for hand. All patients will be evaluated before treatment, immediately after treatment, and 3 months after the end of the treatment.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with hemiplegic cerebral palsy diagnosed by the specialist
- •Active wrist extension ≥ 20 °
- •Gross Motor Function Classification System score: 1-2
- •Manual Ability Classification System score: 1-3
- •The ability to follow simple commands and participate in the task
排除标准
- •Contracture in upper limb
- •Absence of vision and hearing problems
- •Uncontrolled seizure
- •Lack of movement in the hemiplegic upper limb
- •History of orthopedic surgery (tendon transfer / tendon lengthening) to the affected upper extremity
- •Any treatment for upper limb in the last 6 months including BTX-A or orthopedic interventions
研究组 & 干预措施
Intervention
Virtual reality exercises using Hand Tutor for 8 weeks
干预措施: Virtual Reality Exercises using Hand Tutor (Other)
Control
Home exercises for 8 weeks
结局指标
主要结局
Assisting Hand Assessment (AHA)
时间窗: Within 7 Days
AHA measures are valid and reliable for children aged between 18 months and 12 years with the diagnosis of unilateral cerebral palsy. It measures how effectively children with unilateral hand dysfunction use their involved hand in collaboration with their uninvolved hand to perform bimanual tasks.The test is administered in two steps. First, a video-recorded play session lasting 10 to 15 minutes is conducted with specific toys from the AHA test kit.Second, the scoring is performed by a review of the video on 22 items by certificated professional. The AHA version 4.4 includes 22 test items each rated on a 4-point scale, with a total raw score range between 22-88 points. The higher score indicating higher ability.
次要结局
- Hand Grip Measurement(Within 7 Days)
- ABILHAND(Within 7 Days)
- Range of Motion (ROM)(Within 7 Days)
- Modified Ashworth Scale (MAS)(Within 7 Days)
- TARDIEU SCALE(Within 7 Days)
- Pulp Pinch Strength Measurement(Within 7 Days)
研究者
Sara Asghari Kaleibar
Sara ASGHARI KALEIBAR, MD Resident in the Department of Physical Medicine and Rehabilitation Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey
Istanbul University