Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia

Study Overview
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Brief Summary
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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 .

Detailed Description
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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. evaluation was done before and after treatment. treatment include traditional exercises for gait and balance for both groups in addition to use the antigravity shoes for study group.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: gait training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 diplegic children of both gender aged from 6 to 8, GMFCS levelII and II . has gait defecits including percentage of gait cycles. Exclusion Criteria: recent surgical intervention. orthopedic deformity in lower limbs. sever vision or hearing problems.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups study and control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>15 children received the regular exercise program including classical gait training for diplegic children (30 minutes exercises + 30 minutes gait training) | Other: gait training<br>* training for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait<br>* Other names: gait rehabilitation;|
| Experimental: study group<br>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) | Other: gait training<br>* training for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait<br>* Other names: gait rehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gait time percentage for right lower limb | the time of stance and swing phases as a percentage for right lower limb during gait | after 3 months of treatment | 
| gait time percentage of left lower limb | the time of stance and swing phases as a percentage for left lower limb during gait | after 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of function through GMFCS | changing the level of function by using the GMFCS | before and after 3 months of treatment |