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临床试验/NCT05903534
NCT05903534已完成不适用

Effects of Pediatric Endurance and Limb Strengthening (PEDALS) Program Versus Lower Limb Strength Training in Diplegic Cerebral Palsy

Riphah International University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Goniometer

研究概览

简要总结

Cerebral palsy (CP) is a neurodevelopmental disorder is caused by damage to the developing brain and is characterized by abnormalities of muscle tone, mobility, and motor abilities. CP may only be recognized at 3-5 years of age. Pediatric endurance and limb strengthening (PEDALS) program is important to achieve endurance, gross motor function and some measure of strength in patients with diplegic cerebral palsy. The aim of this study is to evaluate the comparative effects of pediatric endurance and limb strengthening program with lower limb strength training in diplegic cerebral palsy.

详细描述

A randomized control trial will be conducted through convenient sampling. Subjects will randomly allocated into two groups, group A will receive pediatric endurance and limb strengthening program, while group B will receive lower limb strength training. The duration of the treatment will be 8 weeks. Goniometer, six minute walk test and gross motor function measure scale-88 will be used to as outcome measure. Goniometer measures the available range of motion at a joint, six minute walk test measure cardiorespiratory or aerobic endurance, the GMFM-88 provides more descriptive information about motor function for very young children or children with more complex motor disability, Data will be analyzed on SPSS version 27, 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
Treatment
盲法
Single (Participant)

盲法说明

Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 6-12 years of age, children with cerebral palsy
  • Ability to follow simple verbal direction
  • Ability to walk independently with or without an assistive device for short distance (GMFCS) level 1-11
  • Good or fair selective voluntary motor control for at least one limb

排除标准

  • Orthopedic surgery
  • Botulinum toxin injection within the preceding 3 months
  • Serial casting or new orthotic devices within the preceding 3 months
  • Initiation of oral medication that effect the neuromuscular system
  • Significant hip, knee or ankle joint contractures
  • Inability of unwillingness to maintain age- appropriate behavior

结局指标

主要结局

Goniometer

时间窗: 8 weeks

It will measure lower limb range of motion

Gross motor function measure 88

时间窗: 8 weeks

the GMFM-88: The Gross Motor Function Measure (GMFM-88) is commonly used in the evaluation of gross motor function in children with cerebral palsy (CP). It consists of 88 items that have been categorized into 5 dimensions of gross motor function: lying and rolling; sitting; crawling and kneeling; standing; and walking, running, and jumping. Many studies use GMFM to assess the effectiveness of interventions in children with CP

Six minute walk test

时间窗: 8 weeks

6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. It is important for rehabilitation providers to assess endurance of children with CP. Clinicians rely on readily available, easily-administered measures to establish a baseline and measure change over time 6-minute walk test (6MWT)are designed for these purposes

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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