"Remind to Move" Treatment Versus Constraint-induced Movement Therapy for Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 主要终点
- Jebsen-Taylor Hand Function Test (JTHFT)
研究概览
简要总结
The aim of this study was to determine the effects of an innovative child-friendly remind-to-move treatment (RTM) treatment by comparing it with constraint-induced movement therapy (CIMT) on upper extremity outcomes in children with hemiplegic Cerebral Palsy. In an evaluator-blinded randomized controlled trial, 73 children, among of whom 20 in Manual Ability Classification System level I, 38 level II, and 15 level III, were recruited from 3 special schools and randomized to receive 75-hour RTM (n=25) and CIMT (n=24) programme over 15-weekdays, and conventional treatment (n=24). The primary outcomes were Jebsen-Taylor Hand Function Test (JTHFT) and Bruininks-Oseretsky Test of Motor Proficiency (BOTMP-II) Subtest 3 for assessing the motor efficiency at baseline, posttest, and 1- and 3-month follow-up.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Hemiplegic Cerebral Palsy
- •Aged 5 to 16 years
- •Ability to follow instructions
- •Ability to grasp and release light objects, and at least 20° wrist and 10°fingers in metacarpophalangeal joints extension from full flexion for the affected hand
- •Manual Activity Classification System (MACS) 19 grades I, II or III of the affected hand
排除标准
- •Severe cognitive, visual, or auditory disorder
- •Seizure and health problems not associated with cerebral palsy
- •Predominant spasticity or contracture grades more than 3 of Modified Ashworth Scale 20 on wrist and finger flexors, forearm pronators and ⁄ or thumb adductors
- •Receiving new pharmaceutical (i.e. botulinum toxin injections) and/or surgical interventions within 6-month before study
研究组 & 干预措施
Conventional rehabilitation
Conventional splinting, muscle strengthening, stretching, and neurodevelopmental facilitation techniques for 1hr daily, 2 day per week for 3 weeks.
干预措施: Conventional rehabilitation (Behavioral)
Remind-to-move
RTM involved a wristwatch device worn on more-affected arm which emitted sensory cueing continuously to remind the children to use the more-affected hand to engage in daily activities or complete bimanual tasks intensively, 5 hour per day, 5 days every week, for 3 consecutive weeks.
干预措施: Remind-to-move (Behavioral)
Modified constraint induced movement therapy (mCIMT)
children were encouraged to wear a customer-made volar resting splint that extended from below the elbow to the fingertips on their noninvolved hands for 5 hour daily except for toileting, writing and specific physical sports, for 3 weeks. Each child was supervised by one therapist to complete structured unimanual practice with the affected hand during the supervised session, 5 days every week, for 3 consecutive weeks.
干预措施: Modified constraint induced movement therapy (Behavioral)
结局指标
主要结局
Jebsen-Taylor Hand Function Test (JTHFT)
时间窗: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
Bruininks-Oseretsky Test of Motor Proficiency (2nd ed.) (BOTMP-II)
时间窗: Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training)
次要结局
- Caregiver Functional Use Survey (CFUS)(Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training))
- Ratio of movement duration on the affected hand from accelerometer(Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training))
- Active range of motion (AROM) as measured by digital goniometer(Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training))
- Power grip strength as measured by dynamometer(Change from Baseline at 3 weeks (plus follow up at 1 month and 3 months after training))
研究者
Kenneth N. K. Fong
Associate Professor
The Hong Kong Polytechnic University