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临床试验/NCT06233136
NCT06233136已完成不适用

Effect of Leg Pedalling Exercise From Inclined Position on Functional Ability and Trunk Control in Children With Diplegic Cerebral Palsy

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Assessment of trunk control

研究概览

简要总结

Statement of the problem:- Does the lower limb pedalling exercise from inclined position improve functional ability and trunk control in children with diplegic cerebral palsy? Null Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position on functional ability and trunk control in children with diplegic cerebral palsy

详细描述

Subjects A convenient sample of children diagnosed as spastic diplegic cerebral palsy (CP) from both sexes will be recruited based on a pilot study according to the inclusion and exclusion criteria. They will be selected from the out-patient private clinics in Giza and Tenth of Ramadan City.

Study design:

Randomized controlled clinical trial. Children will receive intervention type randomly, 15 child received the designed physical therapy program and the pedaling exercise from inclined position and the other 15 child receieved the designed physical therapy program only. Children will be assessed by measuring functional ability with Gross Motor Functional measures and trunk control with trunk control measurement scale

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

Single

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • .Age ranges from 6-9 years. .Grade 1, 1+ of the Modified Ashworth Scale.
  • .Level II, III according to Gross MotorFunctional Classification System (GMFCS).
  • .Able to pedal independently on a static bicycle.
  • .Ability to follow command.

排除标准

  • .Significant visual or auditory impairments.
  • .Structural or fixed deformities of lower extremities.
  • .Perception disorders.
  • .Botox injection in the lower extremity in the past 6 months.
  • .Lower extremity surgery within the past 6 months.

研究组 & 干预措施

Leg Pedalling exercise and designed physical therapy program

Experimental

Each child in the experimental group will be positioned in semi-reclined position with 45 degree trunk flexion during the application of cycling Sessions will be 30 minutes per session, three times per week, for two successive months The designed physical therapy program It will be applied for all participated children in both groups. It includes;

  1. Flexibility exercises
  2. Static and dynamic balance exercises
  3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month

干预措施: Leg pedalling exercise (Device)

Leg Pedalling exercise and designed physical therapy program

Experimental

Each child in the experimental group will be positioned in semi-reclined position with 45 degree trunk flexion during the application of cycling Sessions will be 30 minutes per session, three times per week, for two successive months The designed physical therapy program It will be applied for all participated children in both groups. It includes;

  1. Flexibility exercises
  2. Static and dynamic balance exercises
  3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month

干预措施: The designed physical therapy program (Other)

Designed physical therapy program

Active Comparator

The designed physical therapy program It will be applied for all participated children in both groups. It includes;

  1. Flexibility exercises
  2. Static and dynamic balance exercises
  3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month

干预措施: The designed physical therapy program (Other)

结局指标

主要结局

Assessment of trunk control

时间窗: 2 months for each participant

Assessment of change of trunk control carried out by using trunk control measurement scale

The gross motor function scale

时间窗: 2 months for each participant

Assessment of change of functional ability carried out by using gross motor function measures

次要结局

未报告次要终点

研究者

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

Alaa Bahgat mahmoud Hasan

Scientific researcher

Cairo University

研究点 (1)

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