- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04117282
Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia
Effect of Antigravity Shoes on Improving the Quality of Gait in Children With Spastic Diplegia (Using 2 D Gait Analysis)
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza
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Cairo, Giza, Egypt, 02
- Faculty of Physical Therapy,Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control group
15 children received the regular exercise program including classical gait training for diplegic children (30 minutes exercises + 30 minutes gait training)
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training for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait
Other Names:
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Experimental: study group
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)
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training for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gait time percentage for right lower limb
Time Frame: after 3 months of treatment
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the time of stance and swing phases as a percentage for right lower limb during gait
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after 3 months of treatment
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gait time percentage of left lower limb
Time Frame: after 3 months of treatment
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the time of stance and swing phases as a percentage for left lower limb during gait
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after 3 months of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
level of function through GMFCS
Time Frame: before and after 3 months of treatment
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changing the level of function by using the GMFCS
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before and after 3 months of treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nahla Mohamed, lecturer, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pediatric physical therapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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