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

Status

Completed

Conditions

Intervention / Treatment

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:

  1. children diagnosed as spastic diplegia or hemiplegia;
  2. the ability to stand independently without support for not less than 30 seconds;
  3. the ability to walk independently; a classification of level II in the Gross Motor Function Classification System (GMFCS);
  4. and capability to understand simple verbal commands.

Exclusion criteria:

  1. Participants were excluded if they were treated for lower limbs orthopedic surgical or with botulinum toxin injection within the last 6 months
  2. 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.

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

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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