NCT03237520Unknown不适用
Comparing Efficacy of Virtual Reality Therapy With Modified Constraint Induced Movement Therapy (mCIMT) Versus mCIMT Alone, for 5-18 Years Children With Hemiparetic Cerebral Palsy - An Open Label, Randomized Controlled, Superiority Trial
All India Institute of Medical Sciences, New Delhi0 个研究点目标入组 60 人开始时间: 2017年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- 8 weeks of VRT with mCIMT versus mCIMT alone
研究概览
简要总结
This study intends to compare the efficacy of of virtual reality therapy(VRT) with modified constraint induced movement therapy(mCIMT) versus modified constraint induced movement therapy alone for children with hemiparetic cerebral palsy aged >/= 5-18 years, in improving the upper limb functions, as measured by the QUEST (Quality of Upper Extremity Skill Test score) over 3 months of intervention.
详细描述
Sample size: Based on the previous studies, on CIMT in hemiparetic CP children using QUEST scores,
- Anticipated increase in total QUEST scores at 2 months in the mCIMT group:
10 + 5(mean + SD)
- Anticipated increase in total QUEST scores at 2 months in the mCIMT+ VRT group:
15 + 5(mean + SD)
- Alpha error= 5%
- Power= 80%
- Calculated sample size : 23 children in each group
- Considering loss due to attrition of roughly 25%,investigators would enroll 30 children in each of the two groups.
- At least 10 children in each group will be analyzed with baseline and follow up fMRI and DTI. These children in each group will be selected through systematic sampling method.
Method:
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)
盲法说明
The outcome assessor will be masked to the group allocation and the intervention
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged >5-18 years
- •Children with hemiparetic cerebral palsy * (both perinatal and postnatal acquired brain injury)
- •Intelligence quotient >70 (Binet Kamat Test/Malin's Intelligence Scale for Children)
- •Modified Ashworth scoring 1-3 for affected limb
- •Can sit independently or with support (Gross Motor Functional Classification System stage: 1-4 and Manual Ability Classification System stage: 1-3)
- •Preserved vision and hearing (with or without correction)
排除标准
- •Uncontrolled epilepsy as defined by seizure frequency >1/month for preceding 3 months
- •Severe concurrent illness or diseases not associated with CP or unstable medical conditions like pneumonia
- •Genetic or syndromic associations
- •Children diagnosed with autistic spectrum disorders
- •Modified Ashworth scale score more than 3 at shoulder/elbow /wrist
- •Contractures of the affected limb
- •Severe movement disorder like dystonia, choreo-athetosis or ballismus interfering with purposeful limb movement
- •Any congenital brain malformation detected on conventional MRI brain
- •Recent orthopedic surgery/cast/splint in the affected limb
- •Botulinum toxin/phenol blocking in the affected limb in the past 6 months or are planning to receive in the study period
- •Those receiving tone modifying agents in week before enrollment(Tizanidine,baclofen,benzodiazepines,dantrolene)
- •Any contraindications for MRI - examples- presence of pacemaker, metallic implant
结局指标
主要结局
8 weeks of VRT with mCIMT versus mCIMT alone
时间窗: Within 1 week of completing 8 weeks, from the beginning of intervention
The primary objective is to evaluate and compare the efficacy of 8 weeks of modified constraint induced movement therapy (mCIMT) reinforced with virtual reality therapy(VRT) with modified constraint induced movement therapy alone, in improving the upper limb function in \>5-18 years old children with hemiparetic cerebral palsy, by using the QUEST scoring(Quality Of Upper Extremity Skill Test Score) in the two groups.
次要结局
- To compare the improvement in the sub domains(dissociated movements, grasp, protective extension and weight bearing) of QUEST score between the 2 groups(Within 1 week of completing 8 weeks, from the beginning of intervention)
- Comparing the improvement in speed of movements between 2 groups(Within 1 week of completing 8 weeks,from the beginning of intervention)
- Comparing the improvement in muscle strength between 2 groups(Within 1 week of completing 8 weeks,from the beginning of intervention)
- fMRI changes copared with clinical improvement in 2 groups before and after intervention(Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention)
- Functional Magnetic Resonance Imaging(fMRI) in the 2 groups(Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention)
- DTI(Diffusion Tensor Imaging) changes compared with clinical improvement in 2 groups before and after intervention(Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention)
- Diffusion Tensor Imaging changes in 2 groups(Upto 1 week before starting mCIMT+ VRT program and within 1 week of completing 08 weeks, from the beginning of the intervention)
- Sustained improvement(Baseline and at 12 weeks of intervention)
- Quality of life improvement(At the end of 8 weeks, from the beginning of intervention)
- Compliance(At the end of 8 weeks, from the beginning of intervention)
研究者
Sheffali Gulati
Professor
All India Institute of Medical Sciences, New Delhi
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