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临床试验/NCT04117282
NCT04117282已完成不适用

Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia (Using 2 D Gait Analysis)

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月3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
30
试验地点
2
主要终点
gait time percentage of left lower limb

研究概览

简要总结

Improving the quality of gait in the diplegic children is a major concern in the rehabilitation program. Thirty children with spastic diplegia were distributed equally into 2 groups, group A (control) and group B (study). Group A had received the traditional physical therapy program for 30 minutes and 30 minutes traditional gait training, while group B had received 30 minutes gait training with antigravity shoes in addition to the traditional exercise program for 30 minutes, percentage of stance and swing phase of gait were measured by 2 D gait analysis for children of both groups pre and after 3 successive months of treatment program, also function level of gait were assessed pre and post treatment by GMFCS .

详细描述

Thirty children with spastic diplegia, their age ranged from 6 to 8 years old, were distributed equally into 2 groups: group A (control) and group B (study) They could walk with limitation or holding on according to GMFCS (level II &III). (Palisano et al., 2008). Increased time for stance phase and decreased swing phase time was recorded when evaluated by 2D gait analysis.

Control group (A):

The children in this group had received traditional physical therapy exercise program designed for those cases for 30 minutes in addition to gait training program for 30 minutes / day, 3 times / week for 3 successive months.

Study group (B):

The children in this group received the same traditional exercise program for 30 minutes in addition to gait training program for 30 minutes using the antigravity shoes.

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
None

入排标准

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

入选标准

  • 30 diplegic children of both gender aged from 6 to 8,
  • GMFCS levelII and II . has gait defecits including percentage of gait cycles.

排除标准

  • recent surgical intervention.
  • orthopedic deformity in lower limbs.
  • sever vision or hearing problems.

研究组 & 干预措施

control group

Active Comparator

15 children received the regular exercise program including classical gait training for diplegic children (30 minutes exercises + 30 minutes gait training)

干预措施: gait training (Other)

study group

Experimental

15 diplegic child received the same exercise program including the use of the antigravity shoes for gait training (30 minutes exercises + 30 minutes gait training)

干预措施: gait training (Other)

结局指标

主要结局

gait time percentage of left lower limb

时间窗: after 3 months of treatment

the time of stance and swing phases as a percentage for left lower limb during gait

gait time percentage for right lower limb

时间窗: after 3 months of treatment

the time of stance and swing phases as a percentage for right lower limb during gait

次要结局

  • level of function through GMFCS(before and after 3 months of treatment)

研究者

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

Nahla Mohamed Ibrahim

Doctoral degree (lecturer)

Cairo University

研究点 (2)

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