Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04636424
Collaborator
(none)
114
1
2
11
10.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: assesment of gait
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Weight Distribution Asymmetry in Relation to Speed During Gait in Children With Spastic Cerebral Palsy.
Actual Study Start Date :
Dec 3, 2019
Actual Primary Completion Date :
Mar 5, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: spastic diplegic group

assessment of the speed and weight distribution during gait

Other: assesment of gait
speed and weight distribution during gait

Experimental: hemiplegic group

assessment of the speed and weight distribution during gait

Other: assesment of gait
speed and weight distribution during gait

Outcome Measures

Primary Outcome Measures

  1. speed of gait [12 weaks]

    the velocity of walking

Secondary Outcome Measures

  1. foot to foot distribution [12 weaks]

    weight loaded on each lower limb during gait assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Physical Therapy,Cairo University Cairo Giza Egypt 02

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Nahla Mohamed, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nahla Mohamed Ibrahim, Doctoral degree (lecturer), Cairo University
ClinicalTrials.gov Identifier:
NCT04636424
Other Study ID Numbers:
  • correlation study
First Posted:
Nov 19, 2020
Last Update Posted:
Nov 19, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nahla Mohamed Ibrahim, Doctoral degree (lecturer), Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2020