- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04246658
Effect of Platform Swing Walkway on Locomotor Behavior in Diplegic Children
January 22, 2021 updated by: hanaa mohsen
Effect of Platform Swing Walkway on Locomotor Behavior in Children With Diaplegia
Locomotor activity is accompanied by a number of sensory stimuli: visual, auditory, olfactory, vestibular, and somatosensory.
When improving motor skills, incorporating postural reflexes, creating synchronized eye movements, and visual attention skills, the vestibular system is particularly important.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Thirty diaplegic cerebral palsied children of both sexes, ranged in age from 3 to 6 years enrolled in this study.
They randomly assigned into two groups of equal number; control group (A), study group (B).
Group (A) groups received the conventional physical therapy program based on neurodevelopmental approach for such cases.
Whereas study group (B) received the same conventional physical therapy program given to group (A) in addition to gait training on platform swing walkway for 30 minute.
All children were assessed before and after the treatment program by using 2D video based gait assessment system to measure the percentage of swing and stance phase, also GMFM was used to assess standing and walking, running, and jumping abilities, domains (D) and (E).
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
-
-
-
Cairo, Egypt
- Badr Univesity in Cairo (BUC)
-
-
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:
- were cognitively competent
- able to understand and follow instructions.
Exclusion Criteria:
- if they had fixed contractures
- deformities of the spine, upper or lower extremities,
- visual or respiratory disorders.
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
gait training on platform swing walkway for 30 minute.
|
traditional physical therapy program
gait training on platform swing walkway for 30 minute.
|
Experimental: control group
conventional physical therapy program
|
traditional physical therapy program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Growth Motor Function Measure Scale (GMFM).
Time Frame: pre intervension and after three months of the intervention to asses the improvent in standing and walking .the highest score indicate improvementg
|
Growth Motor Function Measure Scaleis the scale tat will assess the functional gross preinterventiona and after 3 months of the treatment program
|
pre intervension and after three months of the intervention to asses the improvent in standing and walking .the highest score indicate improvementg
|
2D, video based gait assessment system:
Time Frame: 2D, video based gait assessment system asses the change in the stance in swing phase before and after three months of the intervention program .
|
Tracker Video Analysis and Modeling Tool
|
2D, video based gait assessment system asses the change in the stance in swing phase before and after three months of the intervention program .
|
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 (Actual)
September 1, 2019
Primary Completion (Actual)
January 27, 2020
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
January 15, 2020
First Submitted That Met QC Criteria
January 28, 2020
First Posted (Actual)
January 29, 2020
Study Record Updates
Last Update Posted (Actual)
January 26, 2021
Last Update Submitted That Met QC Criteria
January 22, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Hana1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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