Immediate and Maintaining Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- change from baseline of muscle tone and basic motor abilities of the upper limb muscles in 12 and 24 weeks
研究概览
简要总结
Immediate and maintaining Efficacy of new protocols in the treatment of upper limb dysfunctions in patients with cerebral palsy.
详细描述
Cerebral palsy (CP) is the most common childhood motor disability. Spasticity and loss of dexterity are the major problems for motor disability of upper extremity (UE) in patients with CP. This study propose two novel treatment protocols: sensory electrical stimulation (SES) and virtual reality constraint-induced therapy (VRCIT) to improve function of UE in patients with CP. Investigators hypothesize that combined SES and VRCIT treatment have better effect than single therapy (SES or VRCIT).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Diagnosis with spastic CP with Gross Motor Function Classification System(GMFCS) levels I-IV
- •Aged 2-24 years
- •Ability to undergo clinical assessment
- •Ability to comprehend commands and cooperate during an examination
排除标准
- •Chromosomal abnormalities
- •Progressive neurological disorder or severe concurrent illness or disease not typically associated with CP
- •Active medical conditions such as pneumonia or poor physical conditions that would interfere with participation
- •Any major surgery or nerve block in the preceding 3 months
- •Metabolic or hormonal disturbance
- •Cardiovascular disorder
- •Poor tolerance or a poor cooperation during assessment
结局指标
主要结局
change from baseline of muscle tone and basic motor abilities of the upper limb muscles in 12 and 24 weeks
时间窗: baseline, 12weeks, 24weeks
Muscle tone of the upper limb muscles assessment by Modified Ashworth Scale and Myoton (© 2011 Myoton AS.). Basic motor abilities included the assessments of the Bruininks-Oseretsky Test of Motor Proficiency II (BOT II), Melbourne Assessment 2 (MA2), Quality of upper extremity skills test (QUEST). The measure is a composite.
次要结局
- change from baseline of quality of life in 12 and 24 weeks(baseline, 12weeks, 24weeks)
- change from baseline of activities of daily living (ADL) in 12 and 24 weeks(baseline, 12weeks, 24weeks)
- change from baseline of bone mineral density in 12 and 24 weeks(baseline, 12weeks, 24weeks)
- change from baseline of Metabolism and Body composition in 12 and 24 weeks(baseline, 12weeks, 24weeks)
- change from baseline of severity in 12 and 24 weeks(baseline, 12 weeks, 24 weeks)
- change from baseline of kinematic analysis in 12 and 24 weeks(baseline, 12weeks, 24weeks)
- change from baseline of muscle strength and endurance in 12 and 24 weeks(baseline, 12 weeks, 24 weeks)
- change from baseline of reaction-time in 12 and 24 weeks(baseline, 12 weeks ,24 weeks)