- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05428865
Correlation Between Body Mass Index, Selective Motor Control and Functional Ability in Children With CP
Correlation Between Body Mass Index, Selective Motor Control, Spasticity and Functional Ability in Children With Diplegic Cerebral Palsy
PURPOSE:
To investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.
BACKGROUND:
Cerebral palsy is primarily a disorder of movement and posture
HYPOTHESES:
There is no correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.
RESEARCH QUESTION:
Is there a correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- spastic diplegic CP, age from 6 to 9 years, able to follow verbal commands or instructions during testing procedures, 1+ and 2 according to Modified Ashworth scale (MAS), (GMFCS E&R) selected Level II , III.
Exclusion Criteria:
- patients who had contractures or fixed deformities related to the joints of the lower limbs, injection with Botulinium toxin or any orthopaedic surgery in lower limbs within one year before study,
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The selective control assessment of lower extremity (SCALE)
Time Frame: through study completion, an average of 1 year
|
is a tool used for assessment of SVMC in children with spastic CP.
|
through study completion, an average of 1 year
|
|
Anthropometric measurements
Time Frame: through study completion, an average of 1 year
|
include weight (measured using a calibrated digital scale and height (measured using Harpenden Stadiometer).
Body mass index (BMI) was calculated as weight (kg)/height (m2).
higher scores indicate obesity
|
through study completion, an average of 1 year
|
|
Wee Functional Independence Measure (Wee-FIM)
Time Frame: through study completion, an average of 1 year
|
is a tool used to assess activities of daily living (ADL) in children with cerebral palsy.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Ashworth Scale (MAS)
Time Frame: through study completion, an average of 1 year
|
For grading degree of spasticity.
|
through study completion, an average of 1 year
|
|
Gross Motor Function Classification System Expanded and Revised for CP children between 6th and 12th birthday:
Time Frame: through study completion, an average of 1 year
|
The Gross Motor Function Classification System (GMFCS E&R) is a classification system that describes the level of gross motor function of CP children according to abilities and limitations
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Faculty OP Therapy, lecturer, Cairo university
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003833
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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