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临床试验/CTRI/2024/06/069547
CTRI/2024/06/069547尚未招募不适用

Effect of 12-week adaptive sport training on physical and cognitive functions in children with mild intellectual disability- a pilot interventional study

MGM school of physiotherapy1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
52
试验地点
1
主要终点
Pediatric quality of life scale- to assess physical activity and participation

研究概览

简要总结

To explore theeffect of 12-week adaptive sport training on physical and cognitive functions in children with mild intellectual disability

 To evaluate and compare the effect on physical functions including agility, speed, balance and flexibility in children with mild intellectual disability for a 12-week pre and post adaptive sport training intervention

To evaluate and compare the effect on cognitive functions including selective attention in children with mild intellectual disability for a 12-week pre and post adaptive sport training intervention

The expected outcome of the study is to investigate the effects of adaptive sport training on physical and cognitive functions in children with mild intellectual disability

研究设计

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

入排标准

年龄范围
6.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Fifty two ambulatory children diagnosed with mild intellectual disability with an IQ score between 50 to 75 age group 6 to 14) {According to ICD 10 classification Code (G 80) Children willing to participate in the study Children who will be able to follow an exercise intervention and who are able to follow verbal commands Children diagnosed with Down syndrome, cerebral palsy (GMFCS level 1 and 2) ADHD, Autism, fine motor dysfunction {According to ICD 10 classification Code (G 80)}.

排除标准

  • Children diagnosed with cerebral palsy with GMFCS level 3,4,5 According to ICD 10 classification Code (G 80) Children attending a sports program at school level for the past 6 months Children having any uncorrected cardiovascular abnormalities {According to ICD 10 classification Code: (I00 to I99)} Children taking any medications that could interfere with the study results Children who underwent recent surgery in the past one year Any existing fracture or soft tissue injuries, pulmonary, metabolic and psychological condition which affects the performance {Disorders of continuity of bone M 84, Other disorders of bone density and structure M85, Disorder of eye and adnexa (H0 to H59), Diseases of the respiratory system (J0 to J99)}.

结局指标

主要结局

Pediatric quality of life scale- to assess physical activity and participation

时间窗: Baseline and 12 weeks

GMFM-88(Gross motor function measure)- to assess physical activity and participation

时间窗: Baseline and 12 weeks

Pediatric balance scale- To assess balance

时间窗: Baseline and 12 weeks

次要结局

  • Zig zag test is to assess agility(10 m sprint test is to assess Speed)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shivani N Chavan

MGM School of Physiotherapy, MGM Institute of health science

研究点 (1)

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