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临床试验/NCT06943508
NCT06943508招募中不适用

Effects of Nordic Walk on Balance and Functional Strength in Children With Down Syndrome

Riphah International University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Pediatric berg balance scale

研究概览

简要总结

Down syndrome (DS) is one of the more commonly occurring genetic disorders, where mental retardation is combined with nutritional diseases. It is caused by having a third copy of chromosome 21, and there exist 3 forms; Simple Trisomy 21, Translocation Trisomy and Mosaic Trisomy. It is coupled with mental retardation, congenital heart defects, gastrointestinal anomalies .Nordic walking exerts beneficial effects on resting heart rate, blood pressure, exercise capacity, maximal oxygen consumption, and quality of life in patients with various diseases and can thus be recommended to a wide range of people as primary and secondary prevention.

This study will aim to examine the effects of Nordic walk on balance and functional strength in children with Down syndrome. A Randomized Controlled Trial will be conducted through convenient sampling 32 subjects will randomly be allocated into two groups. Group A will include 16 children and will receive conventional exercise program.

Group B will include 16 children and will receive Nordic walking program. Each session will be 30 minutes, 5 sessions per week. The total duration of the study will be 6 weeks.

Pediatric berg balance scale and modified time up and go test, and functional strength test will be used as outcome measure Data will be analyzed on SPSS version 29.0, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.

详细描述

Down syndrome (DS) is one of the more commonly occurring genetic disorders, where mental retardation is combined with nutritional diseases. It is caused by having a third copy of chromosome 21, and there exist 3 forms; Simple Trisomy 21, Translocation Trisomy and Mosaic Trisomy. It is coupled with mental retardation, congenital heart defects, gastrointestinal anomalies, weak neuromuscular tone, dysmorphic features of the head, neck and airways, audio vestibular and visual impairment, characteristic facial and physical features, hematopoietic disorders and a higher incidence of other medical disorders. Children with Down's syndrome (DS) often have greater postural sway and delay in motor development. Muscle weakness and hypotonia, particularly of the lower extremities, are theorized to impair their overall physical health and ability to perform daily activities. Nordic walking exerts beneficial effects on resting heart rate, blood pressure, exercise capacity, maximal oxygen consumption, and quality of life in patients with various diseases and can thus be recommended to a wide range of people as primary and secondary prevention. This study will aim to examine the effects of Nordic walk on balance and functional strength in children with Down syndrome. A Randomized Controlled Trial will be conducted through convenient sampling 32 subjects will randomly be allocated into two groups. Group A will include 16 children and will receive conventional exercise program.

Group B will include 16 children and will receive Nordic walking program. Each session will be 30 minutes, 5 sessions per week. The total duration of the study will be 6 weeks.

Pediatric berg balance scale and modified time up and go test, and functional strength test will be used as outcome measure Data will be analyzed on SPSS version 29.0, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children with age group of 8-13
  • •Both male and female
  • •Functional ability sufficient enough to understand commands, direction and exercise guidance
  • •Have ability to walk 60 meters independently according to 6- minute walk test
  • •Children who can stand and walk with balance problem as revealed from physical examination having 20 to 42 scores on PBS.

排除标准

  • •Uncontrolled seizures
  • •Any kind of orthopedic condition
  • •Registered visually impaired
  • •Atlanto Axial instability
  • •Any chest infection

研究组 & 干预措施

Group A

Active Comparator

Control: Conventional therapy program for 30 min , 5 days per week during 6 week period

干预措施: Conventional Therapy (Other)

Group B

Experimental

Experimental: Nordic Walk for 30 min, 5 days per week during 6 week period

干预措施: Nordic Walk (Other)

结局指标

主要结局

Pediatric berg balance scale

时间窗: Baseline, 6th week

Pediatric balance scale is a modified version of berg balance scale that is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum NORDIC WALK ON BALANCE AND FUNCTIONAL STRENGHT IN CHILDERN WITH DOWN SYNDROME 11 score of 56 points It has good reliability and validity with (ICC=0.997) (r=0.797, p \<0.05)

Timed UP & GO (TUG) test

时间窗: Baseline, 6th week

The timed UP \& GO (TUG) test was developed by Podsiadlo and Richardson in 1991 that is used to assess dynamic balance during the performance of a task. This test measures in second the time required for an individual to stand up from a standard chair with armrest, walk 3m and turn around with reliability and validity of (ICC=0.98; p\<0.01)

Functional Strength Test

时间窗: Baseline, 6th week

To assess functional performance in children with functional exercises in which the large muscle group that are important for standing and walking are being tested. Three closed kinetic chain exercises were chosen. Subjects were instructed to perform as many repetitions as possible in 30 seconds. ICC value ranged from 0.91 to 0.96

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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