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临床试验/NCT06086678
NCT06086678招募中不适用

Improvement of Pulmonary Function in Hemiplegic Cerebral Palsied Children by Using Hydrotherapy and Aerobic Exercises

South Valley University1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3
试验地点
1
主要终点
Pulmonary function tests Forced expiratory volume in the first second (FEV1)

研究概览

简要总结

Cerebral palsy (CP) is the most common motor disability in childhood. Respiratory muscle weakness and a low upper to lower chest diameter ratio are common respiratory dysfunction manifestations in those children which negatively affect their quality of life..

详细描述

Objective

To compare the effectiveness of hydrotherapy versus aerobic exercise on pulmonary function in hemiplegic children with cerebral palsy. Methods: Sixty hemiplegic children (both genders) took part in this research, they were between the ages of 8 to 16, moreover, they were split equally between three groups (A, B and C). The three groups participated in the same conventional physical therapy, group (A) received conventional physical therapy only, group (B) received hydrotherapy, while group (C) received aerobic exercise. Pulmonary function tests are measured by Six-minute walk test (6-MWT) and Spirometer to measure Forced vital capacity (FVC), Forced expiratory volume in the first second (FEV1) as well as FEV1/FVC ratio for all children before the beginning and after the end of this study, the treatment program was applied three sessions per week for 12 consecutive weeks.

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 (Outcomes Assessor)

盲法说明

single

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages ranged from 8 to 16 years.
  • Belonged to levels I to II of the Gross Motor Function Classification System (GMFCS).
  • Spasticity ranged from grade 1 to grade 1+ according to Modified Ashwarth Scale. - Able to walk, no impairment of sensation or other neurological or psychological problems.
  • Clinically and medically stable and able to understand and follow the instructions

排除标准

  • i) Visual and/or auditory defects. ii) Significant shortening and/or deformity of lower extremities. iii) Other neurological problems that affect balance or mentality (e.g. epilepsy) iv) Advanced radiographic alterations comprise (bone destruction, bony ankylosis, knee joint sublaxation as well as epiphysial fracture).
  • v) Lower extremity skeletal abnormalities (whether congenital or acquired). vi) Cardiopulmonary dysfunction.

结局指标

主要结局

Pulmonary function tests Forced expiratory volume in the first second (FEV1)

时间窗: 12 consecutive weeks

Pulmonary function test

Forced vital capacity (FVC)

时间窗: 12 consecutive weeks

Pulmonary function test

FEV1/FVC ratio

时间窗: 12 consecutive weeks

Pulmonary function test

次要结局

  • Six-minute walk test (6-MWT)(12 consecutive weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ragaee Saeed Mahmoud

Lecturer

South Valley University

研究点 (1)

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