- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05420363
Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic CP
June 14, 2022 updated by: Shimaa Aly Mohamed saied, Cairo University
Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic Cerebral Palsy
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
40
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 Contact
- Name: Shimaa A. Mohamed, B.Sc.
- Phone Number: 01287270680
- Email: shimaaaly@cu.edu.eg
Study Contact Backup
- Name: walaa A. Abd El-Nabie, Ass. Prof.
- Email: dr.walaapt@yahoo.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Cairo university , Faculty of Physical Therapy
-
-
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
6 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Their ages will range from 6 to 8 years old.
- The degree of spasticity will range from grade 1 or 1+ according to Modified Ashworth Scale.
- They will be at level II on GMFCS .
- 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 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: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: traditional physical therapy + gait training on different surfaces.
Children in study group will receive designed physical therapy program in addition to gait training on different surfaces.
|
different surfaces materials and textures as sand ,grass, air mattress , foam mattress ,gravels and Rollator
|
|
Experimental: traditional physical therapy + traditional gait training
-Children in control group will receive designed physical therapy program in addition to traditional gait training hard surface .
|
The children will receive gait training over hard surface and even ground only and bare feet without wearing any foot ware or orthosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
kinematics gait parameters
Time Frame: over 3 months
|
step length
|
over 3 months
|
|
kinematics gait parameters
Time Frame: over 3 months
|
step width
|
over 3 months
|
|
kinematics gait parameters
Time Frame: over 3 months
|
double support time
|
over 3 months
|
|
kinematics gait parameters
Time Frame: over 3 months
|
cadence
|
over 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-minute walking test
Time Frame: over 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
July 1, 2022
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
June 10, 2022
First Submitted That Met QC Criteria
June 14, 2022
First Posted (Actual)
June 15, 2022
Study Record Updates
Last Update Posted (Actual)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 14, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003599
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.