- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609422
Scooter Board Activities in Diplegic Cerebral Palsy
April 8, 2023 updated by: Omnya Samy Abdallah Ghoneim, Badr University
Effect of Scooter Board Activities on Trunk Postural Control and Gait in Children With Diplegic Cerebral Palsy
Children with CP may have muscle weakness, changes in mobility, posture, muscle tone, motor coordination and deficits in postural control.
These changes, individually or collectively, affect psychomotor function.
As a result, activities that are performed quickly and readily by healthy children may be difficult and time-consuming for children with CP.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Similar vestibular stimulation can be provided with ascooter-board which requires more active participation on the part of the child.
A scooter-board is simply a wooden board mounted on four castors so that it can roll freely and spin in any direction, it should be big enough to support the middle part of the body while the head, upper chest and legs hang off the ends.
Study Type
Interventional
Enrollment (Actual)
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 Locations
-
-
Cairo
-
Badr, Cairo, Egypt, 002
- Badr university
-
-
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
3 years to 7 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- CP with a diplegia
- Age 7 to 11 years
- Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
- They could walk with limitation or holding on according to GMFCS (level I&II &III) (Palisano et al., 1997).
- They were able to understand and follow verbal instructions
Exclusion Criteria:
- Children with any surgical interference in the upper limb.
- intellectual disability such that simple tasks could not be understood or executed.
- Children with any visual or auditory problems.
- Children with any surgical interference in the lower limb.
- Children with any structural deformities in joints and bones of lower limbs.
- Children who suffer from other diseases or associated disorders that interfered with physical activity.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
Received the designed physical therapy program.
|
|
|
Experimental: study group
Received a designed physical therapy program in addition to scooter bord activities.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk control measurement scale (TCMS)
Time Frame: 3 months
|
TCMS measures trunk control in two basic components: static and dynamic sitting balance. Balance is assessed during flexion, extension, lateral flexion, and rotation movements as selective movements of dynamic sitting. Total score ranges between 0 and 58, and higher scores indicate better control |
3 months
|
|
2D video-based gait assessment system
Time Frame: 3 months
|
2D video-based gait assessment system to measure lateral trunk sway at SLS from frontal view
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Omnya samy, PHD, lecturer
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)
November 11, 2022
Primary Completion (Actual)
March 12, 2023
Study Completion (Actual)
April 8, 2023
Study Registration Dates
First Submitted
November 2, 2022
First Submitted That Met QC Criteria
November 2, 2022
First Posted (Actual)
November 8, 2022
Study Record Updates
Last Update Posted (Actual)
April 11, 2023
Last Update Submitted That Met QC Criteria
April 8, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Omnya 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Private data for this research
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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