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临床试验/CTRI/2024/07/071758
CTRI/2024/07/071758尚未招募不适用

Effect of play based exercise programme on aerobic fitness for individual with neurodevelopmental disability a randomized controlled trial

Dr Sham Wayal1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年8月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
1.Incremental Shuttle Run Test

研究概览

简要总结

Play-based aerobic exercise intervention that improves aerobic fitness in individuals with neurodevelopmental-developmental disabilities developed by two physiotherapists with five years of experience in the field of neurodevelopmental disability. These play-based exercise program were then validated by an expert in the fields of sports and exercise, and finally a list of ten play-based activities were developed.

Approval from the institutional ethics committee will be obtained. Participants will then be recruited based on the inclusion and exclusion criteria from special schools, NGOs and Physiotherapy clinics in and around Chh. Sambhaji Nagar.

The participants in the research will then be allocated into two groups (experimental group and control group) using computerized block randomization. The demographic characteristics and pretest measurements will be completed using 10meter shuttle run test. For experimental group, a selection of 10 games will be shown, and at least five of them will be chosen based on the child’s interests, while for the control group conventional therapy will be given. The program will be implemented for six weeks duration in accordance with ACSM guidelines, with a three-days in a week that accounts for a 50 % rest period. Then the post test measurement will be taken.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children aged 6-12 years.
  • 2.Children with NDD such as cerebral palsy (GMFCS Level I and II) 3.Children with autism spectrum disorder (level 1 severity as per DSM- 5 criteria) 4.Attention deficit-hyperactivity disorder (children with minor impairment in social and school setting according to DSM-5 criteria)
  • Children Diagnosed with Down syndrome (children with physical and cognitive ability to engage in the activities) 6.Children’s who obeys verbal commands.

排除标准

  • Any other associated neurological / musculoskeletal/cardiovascular disorder such as instable seizures, cardiac arrhythmia, hip dysplasia.
  • Children with fixed lower limb contractures or deformities affecting stance and gait.

结局指标

主要结局

1.Incremental Shuttle Run Test

时间窗: 1.At Baseline and After 6 Weeks

次要结局

  • 1.PACE Questionnaire(10 mins)

研究者

发起方
Dr Sham Wayal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sham Wayal

MGM Institute of Physiotherapy

研究点 (1)

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