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临床试验/CTRI/2017/09/009698
CTRI/2017/09/009698已完成不适用

Effects of Transcutaneous Electrical NerveStimulation on Upper Limb Functions in SpasticCerebral Palsy Children - Randomized Controlled Study.

PPG College of physiotherapy2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Mean of Quality of Upper Extremity Skill Test Score

研究概览

简要总结

This study is randomized, single blind, placebo –controlled, parallel – group, multi-centre trial identifying efficacy of Transcutaneous Electrical Nerve Stimulation followed Task Oriented Training for 90 minutes per session for 3 days in a week for 8 weeks in 90 children with spastic hemiplegic cerebral palsy that was conducted in 2 centers in India. The primary outcome measures was the mean modified Tardieu scale Score at 8 weeks. The secondary outcomes were mean score of Quality of Upper Extremity Skill Test Score, ABILHAND-Kids questionnaire, single point tactile registration Score,  two point discrimination Score and Pickup Test Score  at 8 weeks. It showed significant improvement in the Quality of Upper Extremity Skill Test Score, ABILHAND-Kids questionnaire. moderate improvement noticed on modified Tardieu scale Score and Pickup Test Score. and very minimal improvment found on single point tactile registration Score, and two point discrimination Score.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
3.00 Year(s) 至 11.00 Year(s)(—)
性别
All

入选标准

  • •Hemiplegic type of spastic cerebral palsy children with Gross Motor Function Classification System: level II – III and Manual ability classification system for children with cerebral palsy level less then IV.

排除标准

  • •other than spastic children with recent history of epilepsy and antispastic management with in 12 months.

结局指标

主要结局

Mean of Quality of Upper Extremity Skill Test Score

时间窗: 8 weeks

次要结局

  • Mean of Modified Tardieus Scale Score(8 weeks)
  • Mean of Two Point Discrimination Test Score(8 weeks)
  • Mean of Pickup Test Score(8 weeks)
  • Mean of ABILHAND-Kids Questionnaire Score(8 weeks)
  • Mean of Tactile Registration Score(8 weeks)

研究者

发起方
PPG College of physiotherapy
申办方类型
Private hospital/clinic

研究点 (2)

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