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临床试验/CTRI/2024/06/068678
CTRI/2024/06/068678尚未招募2 期

Effect of Backward Walking Training on Balance and Walking Distance in children with Cerebral Palsy A Randomized Controlled Trial

Sonal Choudhary Seth GS Medical College and KEM Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年6月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
42
试验地点
1
主要终点
Balance by pediatric Balance scale

研究概览

简要总结

Backward walking training (BWT) includes supervised gait training on the ground without obstacles in the backward direction. This study aims to evaluate the effect of BWT on the balance and walking distance of children with cerebral palsy (CwCP). The outcome measures are paediatric balance scale (PBS) for balance and 1 minute walk test (1MWT) for assessing walking distance. It is a randomised controlled trial in which control group will receive conventional therapy (60 mins) and experimental group will receive BWT (20 mins) along with conventional therapy (40 mins) for 8 sessions over a period of 4 weeks. CwCP (aged 5-12 years) will be recruited from the paediatric physiotherapy OPD of tertiary health care centre. It will be an all-inclusive study in which all children coming to the set-up and fitting into the inclusion criteria will be included as sample size. Informed consent documents will be obtained from the parents and assent will be obtained from the children. The children will be randomly assigned to two groups using the coin flipping method. Pre intervention outcome measures will be taken. Both groups will receive assigned therapeutic intervention. Post intervention outcome measures will be taken after 8 sessions. This will be assessor blinded. The results will be statistically analysed. Intergroup analysis, depending on normality, will be done using independent T-test (Parametric) or Mann-Whitney (non parametric) to compare paediatric balance scale scores and one minute walk distance between control group and interventional group. Depending on normality, Paired T test (parametric) or Wilcoxon Signed Rank Test (non parametric) will be used to compare Paediatric balance scale score and One minute walk distance for intragroup analysis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
5.00 Day(s) 至 12.00 Day(s)(—)
性别
All

入选标准

  • Gross Motor Functional Classification 1 & 2 Mini mental Scale for children cut off score 24.

排除标准

  • Seizures in the past 6 months Recent lower limb surgeries Recent botulinum toxin injection.

结局指标

主要结局

Balance by pediatric Balance scale

时间窗: At baseline, 4 weeks

次要结局

  • Walking distance by 1 minute walk test(At baseline, 4 weeks)

研究者

发起方
Sonal Choudhary Seth GS Medical College and KEM Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Archana Gore

Physiotherapy school and Centre, Seth G. S. Medical College and KEM Hospital, Mumbai

研究点 (1)

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