Back to resultsEffect of Weight on Hip Excursion During Gait
Primary Purpose
Gait, Spastic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
gait training exercises
Sponsored by
About this trial
This is an interventional treatment trial for Gait, Spastic focused on measuring Ankle;, diplegia, gait, hip excursion, weight
Eligibility Criteria
Inclusion Criteria:
- able to follow simple basic commands,
- identified with gait abnormalities described as level II on Gross Motor Function Classification System (GMFCS).
- diagnosed as spastic diplegia.
Exclusion Criteria:
- severe visual or auditory problems,
- lower limb surgical orthopaedic surgery or
- BOTOX injection in the six months preceding the start of the study,
- and uncontrolled seizures.
Sites / Locations
- Nahla
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
group A
group B
Arm Description
classical gait training
gait training while using weight around ankle
Outcomes
Primary Outcome Measures
hip excursion
hip excursion during gait cycle
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05579535
Brief Title
Effect of Weight on Hip Excursion During Gait
Official Title
Effect of Weight on Hip Excursion During Gait in Children With Diplegia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
October 3, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: Children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children.
Objective: To investigate the effect of using weight around the ankle on hip excursion in children with diplegia.
Detailed Description
Fifty children with spastic diplegic cerebral palsy were assigned into two groups at random (A, B). Both groups had received the same prescribed exercise program with classical gait training for group A and gait training while using weight around ankle for group B. Treatment was conducted for one hour three sessions per week for successive 3 months. Two-dimensional (2D) gait analysis was used to evaluate hip excursion throughout the gait cycle before and after three months of therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Spastic
Keywords
Ankle;, diplegia, gait, hip excursion, weight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
classical gait training
Arm Title
group B
Arm Type
Experimental
Arm Description
gait training while using weight around ankle
Intervention Type
Other
Intervention Name(s)
gait training exercises
Other Intervention Name(s)
gait rehabilitation
Intervention Description
walking exercises in different directions
Primary Outcome Measure Information:
Title
hip excursion
Description
hip excursion during gait cycle
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
able to follow simple basic commands,
identified with gait abnormalities described as level II on Gross Motor Function Classification System (GMFCS).
diagnosed as spastic diplegia.
Exclusion Criteria:
severe visual or auditory problems,
lower limb surgical orthopaedic surgery or
BOTOX injection in the six months preceding the start of the study,
and uncontrolled seizures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahla mohamed, phd
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nahla
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
available when contact the corresponding author including protocol
IPD Sharing Time Frame
after published online
IPD Sharing Access Criteria
authors
Citations:
PubMed Identifier
11851738
Citation
Rodda J, Graham HK. Classification of gait patterns in spastic hemiplegia and spastic diplegia: a basis for a management algorithm. Eur J Neurol. 2001 Nov;8 Suppl 5:98-108. doi: 10.1046/j.1468-1331.2001.00042.x.
Results Reference
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Effect of Weight on Hip Excursion During Gait
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