- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06642922
Gross Motor Abnormalities in Relation to Balance and Weight Indicators in Diplegia (BMI)
Correlation Between BMI , Balance and Gross Motor Capacities in Children with Spastic Diplegia
The goal of this observational study is to investigate the correlation between BMI and balance and gross motor capacities in children with spastic diplegia. The main question it aims to answer is:
Is there a correlation between BMI, balance disturbances and gross motor capacity in children with spastic diplegic cerebral palsy? Researchers compared between results of biodex balance system , GMFM and BMI measures participants stood on biodex balance platform for balance measurement and performed Gross Motor Function Measurement items for gross motor capacities assessment
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Giza, Egypt
- Lamis Neyazy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Children selected according to the following criteria:
- Diagnosed with diplegic CP
- Their ages will range between 5 and 10 years
- Subjects will participate according to BMI classification ; normal weight in the first group and (obese , overweight) in the second group .
- They must be able to stand independently.
- Have minimum height of 100 cm.
- Have a developmental level of grade I or II according to gross motor function classification system GMFM.
- Able to understand and follow instructions.
Exclusion Criteria:
- Auditory defects.
- Visual defects.
- Cognitive or vestibular defects.
- Use of an assistive device.
- Fixed deformity, bony or joint limitation.
- Surgery (tendon lengthening).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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group 1
normal weight group , 53 participants BMI , balance , and gross motor capacities were assessed for each participant
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group 2
overweight and obese group , 51 participants BMI , balance , and gross motor capacities were assessed for each participant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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BMI
Time Frame: 9 months
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Standardized height-weight measuring scale for measurement of weight and height, to be able to calculate BMI Growth charts were used to plot BMI and age separately for girls and boys.
Then, each subject was given a percentile and put into one of two categories: normal (5th to 85th percentile) and overweight, obese (85th and above percentile).
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9 months
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balance assessment
Time Frame: 9 months
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Biodex balance system SD with movable platform was used .The overall stability index (OSI) will be measured as indicator of dynamic balance.
The higher the OSI values, the lower the dynamic balance stability.
Bilateral stance (standing on both legs), eyes open, stability level 5 (12 is the most stable level), and three repeated trials (for more accuracy) for 20 seconds (test time for each trial) were the test conditions
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9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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gross motor capacities
Time Frame: 9 months
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GMC assessed by using dimensions D and E of the Gross Motor Function Measure (GMFM-88) which measures respectively activities in standing, and walking, running, and jumping. .
A 4-point scale was used and scores were expressed as percentages
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9 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: khaled A Mamdouh, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
- Study Director: Hoda A Eltalawy, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
- Study Director: Radwa s Abdulrahman, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, 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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004585
- faculty of physical therapy (Registry Identifier: faculty of physical therapy)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Spastic Diplegia Cerebral Palsy
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University of LahoreCompletedCerebral Palsy (CP) | Spastic Diplegia Cerebral Palsy | Balance | Gross Motor FunctionsPakistan
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Cairo UniversityNot yet recruiting