Magic Camp for Children With Hemiplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
研究概览
简要总结
The proposed study will test the feasibility and effectiveness of a "Magic Camp" in children with spastic hemiplegic cerebral palsy (CP). A single group pretest-posttest design (n=10) will be used to investigate the immediate (2 weeks) and longer-term effect (3 months) of a "Magic Camp" on improving upper limb motor function and health-related quality of life (HRQoL) in children with hemiplegic CP.
详细描述
This project will employ a single group pretest-posttest design to investigate the impact of a "Magic Camp" on the improvement in upper limb motor function, health-related quality of life, and emotional stress among children with spastic hemiplegic CP. After the baseline evaluation, eligible participants will complete one-on-one "magic trick" training 3-hours per day for 2 consecutive weeks. The primary outcome measures will be unimanual function as measured by the Jebsen Taylor Test of Hand Function, bimanual coordination as measured by kinematic parameters using motion analysis, and spontaneous use of the more affected limb in real-life activities that demand the use of both hands as measured by the Children's Hand Experience Questionnaire. Secondary outcome measures will include HRQoL as measured by the Cerebral Palsy Quality of Life Questionnaire, in-depth dyad qualitative interviews of the caregivers and children, and emotional stress as measured by the fingernail cortisol levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spasticity with Modified Ashworth Scale grades between 1 and 3;
- •ability to lift the more affected arm 15 cm above a table surface;
- •impairment of hand function at levels I to III of the Manual Activity Classification System
- •ability to grasp and release light objects with the more affected hand
- •largely nonuse of the more affected hand in daily activities as determined by the Pediatric Motor Activity Log
- •are interested in learning magic tricks
- •have the cognitive and social ability to participate in a camp setting;
- •ability to follow directions in English; and
- •ability to remember simple sequences of actions to perform magic tricks.
排除标准
- •severe muscle spasticity or fixed contracture in the more affected limb that limits functional arm and hand use
- •severe visual or auditory disorders that prevent learning and carrying out the magic tricks
- •serious or recurring medical complications
- •participation in intensive upper limb intervention and/or musculoskeletal and tone management treatments, dorsal rhizotomy, or surgery on the upper limb in the previous 6 months or anticipated within subsequent 6 months
- •start muscle relaxant within the last 3 months; or
- •plan to move to another state within the next 6 months.
结局指标
主要结局
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
时间窗: baseline
Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by occupational therapy (OT) students to assess the efficiency of unimanual grasp and release of items with six tasks. Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills
Bimanual coordination as measured by 3-D kinematic motion analysis
时间窗: baseline
Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal. Each trial ends when the button is pressed. Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials. Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
时间窗: Baseline
CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required. Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items. Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
时间窗: Baseline
CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being. Items are rated on a 9-point scale, and recoded and transformed into scaled scores (transformed to a scale of 1-100) for each domain. An average of the scale scores from all domains (family \& friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted. Higher scores represent better health-related quality of life.
Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
时间窗: Baseline
Fingernail samples from every digit will be collected by clipping directly into a Ziploc® bag to avoid losing any parts of the sample. Nail samples will be sent to the Bio-Analytical Redox Biology (BARB) Core Laboratory, University of Alabama at Birmingham (UAB) for analysis.
次要结局
- Unimanual skill as measured by the Jebsen Taylor Test of Hand Function(from two weeks to three months)
- Bimanual coordination as measured by 3-D kinematic motion analysis(from two weeks to three months)
- Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)(from two weeks to three months)
- Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire(from two weeks to three months)
- Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.(from baseline to three months)
研究者
Hon K. Yuen, PhD
principal investigator
University of Alabama at Birmingham