Evaluation of Repetitive Transcranial Magnetic Stimulation as an Adjunct to Modified Constraint Induced Movement Therapy in Improving Upper Limb Function in Children With Hemiparetic Cerebral Palsy Aged 5 - 18 Years - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Efficacy of 4 weeks of mCIMT with sham/real rTMS
研究概览
简要总结
The investigators aim to evaluate efficacy of TMS as an adjunct to CIMT, assess its safety and tolerability and study cortical excitability with help of TMS which are both rehabilitative therapies for hemiplegic cerebral palsy.
详细描述
Cerebral palsy is the most common motor disability of childhood and Hemiparetic cerebral palsy accounts for about one third of cases. Improving spasticity and upper limb function in these children can lead to better functional outcome and quality of life. TMS is an upcoming rehabilitative modality which has shown promising results in western studies. It has benefits of being non-invasive and has shown to have additive effect when used with CIMT which is standard of care in hemiparetic CP. However, randomized controlled clinical trials comparing it with CIMT alone in hemiparetic CP are very few, none from India so far. The dose, type and duration of TMS and its feasibility in resource limited set up needs to be investigated in children .Therefore, the investigators aim to evaluate efficacy of TMS as an adjunct to CIMT, assess its safety and tolerability and study cortical excitability with help of TMS.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age 5 - 18 years
- •Hemiparetic Cerebral Palsy (perinatal 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 (GMFCS 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 disease 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 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 surgery/cast/splint in affected limb
- •Botulinum toxin/phenol block in affected limb in past 6 months or planned to receive in study period
- •Those receiving tone modifying agents within two weeks before enrolment (Tizanidine, baclofen, benzodiazepines, dantrolene)
- •mCIMT received in last 6 months
- •Any contraindications for TMS - implanted electronic device and non-removable metallic objects near coil e.g. Pacemaker, cochlear implant
研究组 & 干预措施
mCIMT with real rTMS
Modified Constraint Induced Movement Therapy (mCIMT) with real Repetitive Transcranial Magnetic Stimulation (rTMS). 10 sessions of mCIMT will be administered using physical rehabilitation protocol along with real rTMS over contralateral primary motor cortex.
干预措施: mCIMT with real rTMS (Device)
mCIMT with sham rTMS
Modified Constraint Induced Movement Therapy with sham Repetitive Transcranial Magnetic Stimulation (using sham coil). 10 sessions of mCIMT will be administered using physical rehabilitation protocol along with sham rTMS over contralateral primary motor cortex using sham coil which simulated sound and touch of real coil but has no electro-magnetic waves.
干预措施: mCIMT with sham rTMS (Device)
结局指标
主要结局
Efficacy of 4 weeks of mCIMT with sham/real rTMS
时间窗: Within 1 week of end of 4 weeks of mCIMT with sham/real rTMS
◦ To evaluate the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as an adjunct to modified Constraint Induced Movement Therapy (mCIMT) for 4 weeks in improving the Upper Limb Function as per increase in total QUEST score by 5 in 5-18 years old children with Hemiparetic Cerebral Palsy
次要结局
- To evaluate improvement in muscle strength in each group at the end of 4 weeks(within 1 week of end of 4 weeks of mCIMT with sham/real rTMS)
- To evaluate improvement in dissociated movements, grasp, weight bearing and protective extension in each group at the end of 4 weeks(within 1 week of end of 4 weeks of mCIMT with sham/real rTMS)
- To evaluate improvement in speed of upper limb movements in each group at the end of 4 weeks(within 1 week of end of 4 weeks of mCIMT with sham/real rTMS)
- To assess compliance to therapy in each group by Daily Compliance Log(within 1 week of end of 4 weeks of mCIMT with sham/real rTMS)
- To assess improvement in quality of life after the intervention in each group(within 1 week of end of 4 weeks of mCIMT with sham/real rTMS)
- To study for adverse events of TMS(within 1 week of end of 4 weeks of mCIMT with sham/real rTMS)
- To evaluate cortical excitability with TMS at baseline and the end of 4 weeks(within 1 week of end of 4 weeks of mCIMT with sham/real rTMS)
- • To evaluate sustenance of improvement by change in QUEST score at the end of 12 weeks, 8 weeks after stopping supervised treatment in both the groups(within 1 week of end of 4 weeks of mCIMT with sham/real rTMS)
研究者
Sheffali Gulati
Professor
All India Institute of Medical Sciences, New Delhi