Back to resultsWeight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
Primary Purpose
Gait, Spastic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
assesment of gait
Sponsored by
About this trial
This is an interventional other trial for Gait, Spastic focused on measuring assymetry-gait-speed-cerebral palsy
Eligibility Criteria
Inclusion Criteria:
The selection criteria to the diplegic group were as follows:
- children diagnosed as spastic diplegia or hemiplegia;
- the ability to stand independently without support for not less than 30 seconds;
- the ability to walk independently; a classification of level II in the Gross Motor Function Classification System (GMFCS);
- and capability to understand simple verbal commands.
Exclusion criteria:
- Participants were excluded if they were treated for lower limbs orthopedic surgical or with botulinum toxin injection within the last 6 months
- or if they had fixed lower limb deformity.
Sites / Locations
- Faculty of Physical Therapy,Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
spastic diplegic group
hemiplegic group
Arm Description
assessment of the speed and weight distribution during gait
assessment of the speed and weight distribution during gait
Outcomes
Primary Outcome Measures
speed of gait
the velocity of walking
Secondary Outcome Measures
foot to foot distribution
weight loaded on each lower limb during gait assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04636424
Brief Title
Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
Official Title
Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
November 1, 2020 (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
No
5. Study Description
Brief Summary
Background: Improving walking ability is one of the major concerns in therapeutic interventions for children with cerebral palsy.
Aim: determine the relation between the weight distributed on both lower limb and speed during walking.
Detailed Description
sixty children with spastic diplegia (group A) and forty-five with hemiparesis ( group B) with age ranged from ten to twelve, they had spasticity grade 1 and 1+ according to modified ashworth scale and they were able to walk with assistance (level II on Gross Motor Classification System).Evaluation was held by the Biodex gait trainer for measuring weight distribution on both lower limbs and speed during gait to determine if there was a relation between weight distribution asymmetry and the speed of gait of those children
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Spastic
Keywords
assymetry-gait-speed-cerebral palsy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spastic diplegic group
Arm Type
Experimental
Arm Description
assessment of the speed and weight distribution during gait
Arm Title
hemiplegic group
Arm Type
Experimental
Arm Description
assessment of the speed and weight distribution during gait
Intervention Type
Other
Intervention Name(s)
assesment of gait
Intervention Description
speed and weight distribution during gait
Primary Outcome Measure Information:
Title
speed of gait
Description
the velocity of walking
Time Frame
12 weaks
Secondary Outcome Measure Information:
Title
foot to foot distribution
Description
weight loaded on each lower limb during gait assessment
Time Frame
12 weaks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The selection criteria to the diplegic group were as follows:
children diagnosed as spastic diplegia or hemiplegia;
the ability to stand independently without support for not less than 30 seconds;
the ability to walk independently; a classification of level II in the Gross Motor Function Classification System (GMFCS);
and capability to understand simple verbal commands.
Exclusion criteria:
Participants were excluded if they were treated for lower limbs orthopedic surgical or with botulinum toxin injection within the last 6 months
or if they had fixed lower limb deformity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahla Mohamed
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy,Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
02
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
the results will be shared with other researchers as the paper published
IPD Sharing Time Frame
after publication of the paper
IPD Sharing Access Criteria
through the journal of the published paper
Citations:
Citation
Nahla M. Ibrahim, Mai Elsayed Abbass. EFFECT OF PEDAL TRAINING ON GAIT SPEED IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.Int J Physiother Res 2017;5(6):2560-65. ISSN 2321-1822
Results Reference
background
Learn more about this trial
Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
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