- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04636424
Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
November 13, 2020 updated by: Nahla Mohamed Ibrahim, Cairo University
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.
Study Overview
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
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Giza
-
Cairo, Giza, Egypt, 02
- Faculty of physical therapy,Cairo university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: spastic diplegic group
assessment of the speed and weight distribution during gait
|
speed and weight distribution during gait
|
|
Experimental: hemiplegic group
assessment of the speed and weight distribution during gait
|
speed and weight distribution during gait
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
speed of gait
Time Frame: 12 weaks
|
the velocity of walking
|
12 weaks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
foot to foot distribution
Time Frame: 12 weaks
|
weight loaded on each lower limb during gait assessment
|
12 weaks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nahla Mohamed, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 3, 2019
Primary Completion (Actual)
March 5, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
November 8, 2020
First Submitted That Met QC Criteria
November 13, 2020
First Posted (Actual)
November 19, 2020
Study Record Updates
Last Update Posted (Actual)
November 19, 2020
Last Update Submitted That Met QC Criteria
November 13, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- correlation study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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