Back to resultsInfluence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic CP
Primary Purpose
Diplegic Cerebral Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
different walking surfaces
traditional gait training over hard surface only
Sponsored by
About this trial
This is an interventional treatment trial for Diplegic Cerebral Palsy focused on measuring CP , Diplegia
Eligibility Criteria
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.
Sites / Locations
- Cairo university , Faculty of Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
traditional physical therapy + gait training on different surfaces.
traditional physical therapy + traditional gait training
Arm Description
Children in study group will receive designed physical therapy program in addition to gait training on different surfaces.
-Children in control group will receive designed physical therapy program in addition to traditional gait training hard surface .
Outcomes
Primary Outcome Measures
kinematics gait parameters
step length
kinematics gait parameters
step width
kinematics gait parameters
double support time
kinematics gait parameters
cadence
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05420363
Brief Title
Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic CP
Official Title
Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diplegic Cerebral Palsy
Keywords
CP , Diplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
traditional physical therapy + gait training on different surfaces.
Arm Type
Experimental
Arm Description
Children in study group will receive designed physical therapy program in addition to gait training on different surfaces.
Arm Title
traditional physical therapy + traditional gait training
Arm Type
Experimental
Arm Description
-Children in control group will receive designed physical therapy program in addition to traditional gait training hard surface .
Intervention Type
Other
Intervention Name(s)
different walking surfaces
Intervention Description
different surfaces materials and textures as sand ,grass, air mattress , foam mattress ,gravels and Rollator
Intervention Type
Other
Intervention Name(s)
traditional gait training over hard surface only
Intervention Description
The children will receive gait training over hard surface and even ground only and bare feet without wearing any foot ware or orthosis
Primary Outcome Measure Information:
Title
kinematics gait parameters
Description
step length
Time Frame
over 3 months
Title
kinematics gait parameters
Description
step width
Time Frame
over 3 months
Title
kinematics gait parameters
Description
double support time
Time Frame
over 3 months
Title
kinematics gait parameters
Description
cadence
Time Frame
over 3 months
Secondary Outcome Measure Information:
Title
Six-minute walking test
Description
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
Time Frame
over 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shimaa A. Mohamed, B.Sc.
Phone
01287270680
Email
shimaaaly@cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
walaa A. Abd El-Nabie, Ass. Prof.
Email
dr.walaapt@yahoo.com
Facility Information:
Facility Name
Cairo university , Faculty of Physical Therapy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic CP
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