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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05420363
Other study ID # P.T.REC/012/003599
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date September 1, 2022

Study information

Verified date June 2022
Source Cairo University
Contact Shimaa A. Mohamed, B.Sc.
Phone 01287270680
Email shimaaaly@cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Using challenging surfaces of gait training, which require constant adjustments of the body's movement patterns to maintain stability and provide different sensory and proprioceptive inputs to mimic real life situation is appropriate for children with CP. So, the purpose of the current study is to investigate the influence of surface characteristics of gait training on gait kinematics and walking capacity in children with diplegic CP.


Description:

The purpose of the study is to determine the influence of surface characteristics (different surfaces materials and textures) of gait training on kinematics gait parameters (step length, step width, double support time and cadence) and the functional walking capacity in children with diplegic CP.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 8 Years
Eligibility Inclusion Criteria: 1. Their ages will range from 6 to 8 years old. 2. The degree of spasticity will range from grade 1 or 1+ according to Modified Ashworth Scale. 3. They will be at level II on GMFCS . 4. They will be able to follow verbal command or instructions. Exclusion Criteria: - 1. Fixed deformities of lower limbs. 2. Sever visual or auditory problems. 3. History of surgical interference in lower limbs less than one year. 4. Botulinum toxin injections to the lower limb during the previous 4 months.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
different walking surfaces
different surfaces materials and textures as sand ,grass, air mattress , foam mattress ,gravels and Rollator
traditional gait training over hard surface only
The children will receive gait training over hard surface and even ground only and bare feet without wearing any foot ware or orthosis

Locations

Country Name City State
Egypt Cairo university , Faculty of Physical Therapy Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary kinematics gait parameters step length over 3 months
Primary kinematics gait parameters step width over 3 months
Primary kinematics gait parameters double support time over 3 months
Primary kinematics gait parameters cadence over 3 months
Secondary Six-minute walking test The 6-minute walk test (6MWT) is self-paced walking test commonly used to assess functional capacity in children with CP. It can be easily applied in clinical sitting; it reflects functional capacity in terms of activities of daily living over 3 months
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