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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04636424
Other study ID # correlation study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 3, 2019
Est. completion date November 1, 2020

Study information

Verified date November 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date November 1, 2020
Est. primary completion date March 5, 2020
Accepts healthy volunteers No
Gender All
Age group 10 Years to 12 Years
Eligibility 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 Design


Intervention

Other:
assesment of gait
speed and weight distribution during gait

Locations

Country Name City State
Egypt Faculty of Physical Therapy,Cairo University Cairo Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary speed of gait the velocity of walking 12 weaks
Secondary foot to foot distribution weight loaded on each lower limb during gait assessment 12 weaks
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