Correlation Between Anthropometric Measurements And Balance IN Children With Cerebral Palsy
Primary Purpose
Anthropometric Measurements&Balance IN CP Children
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biodex Balane System
Sponsored by
About this trial
This is an interventional diagnostic trial for Anthropometric Measurements&Balance IN CP Children focused on measuring ANTHROPOMETRIC MEASUREMENTS, BALANCE, CEREBRAL PALSY
Eligibility Criteria
Inclusion Criteria:
- Their age will be ranged from 8 to 12 years.
- The degree of their spasticity will be ranged from 1 to 2 according to Modified Ashworth' Scale.
- They will be on level Ⅰ and Ⅱ on Growth Motor Function Classification System (GMFCS).
- They will be able to stand without the use of an assistive device
- Children can follow instructions and understand given orders.
Exclusion Criteria:
- Severe visual or hearing impairment.
- Fixed deformities or surgical interventions in the lower extremities.
- Botulinum toxin injections in the last 6 months.
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
hemiplegic cp
diplegic cp
Arm Description
it will be classified into two subgroups according to body mass index to underweight and healthy weight .
it will be classified into two subgroups according to body mass index to underweight and healthy weight .
Outcomes
Primary Outcome Measures
Is there a correlation between anthropometric measurements and balance in children with cerebral palsy?
The purpose of the current study is to evaluate the correlation between anthropometric measurement (weight, height and BMI) and balance in children with cerebral palsy.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05139758
Brief Title
Correlation Between Anthropometric Measurements And Balance IN Children With Cerebral Palsy
Official Title
Correlation Between Anthropometric Measurements And Balance IN Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
February 28, 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
5. Study Description
Brief Summary
The purpose of the current study is to evaluate the correlation between anthropometric measurement (weight, height and BMI) and balance in children with cerebral palsy.
Detailed Description
The European Society for Clinical Nutrition and Metabolism has pointed out that under-nutrition can led to change in body composition (e.g. depletion of body fat mass) and diminished function and outcome.
The prevalence of under-nutrition in children with CP varies from 3.9 per cent to 71 percent mainly depending on the method of assessment, the severity of motor involvement and feeding problems.
Studies indicate that children and adults with both mild and severe forms of CP have postural impairments. Dysfunctional posture control interferes with the activities of daily life .
Children with CP may have impaired muscle tone and abnormal postural control, both of which affect functional balance capacity.
There were associations between excess body weight and values below normal in some balance conditions, indicating that the anthropometric indicators interfered in the children's postural balance.
There were associations between excess body weight and values below normal in some balance conditions, indicating that the anthropometric indicators interfered in the children's postural balance.
Knowledge of anthropometric measurements and whether they affect balance in children with CP will help clinicians to develop treatment programs which in turn will improve the overall balance and functional abilities of children with CP.
Childeren age will be ranged from 8-12 years and on level Ⅰ and Ⅱ on Growth Motor Function Classification System
Weight would be obtained on a digital scale (UNISCALE )
Standing height was measured using a stadiometer with a fixed vertical backboard and an adjustable head piece.
CDC 2000 charts will be used to measure BMI
The Biodex balance system will be used for the assessment of static and dynamic balance of all children
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anthropometric Measurements&Balance IN CP Children
Keywords
ANTHROPOMETRIC MEASUREMENTS, BALANCE, CEREBRAL PALSY
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hemiplegic cp
Arm Type
Experimental
Arm Description
it will be classified into two subgroups according to body mass index to underweight and healthy weight .
Arm Title
diplegic cp
Arm Type
Experimental
Arm Description
it will be classified into two subgroups according to body mass index to underweight and healthy weight .
Intervention Type
Diagnostic Test
Intervention Name(s)
Biodex Balane System
Intervention Description
The Biodex balance system will be used for the assessment of static and dynamic balance of all children in the current study.
Primary Outcome Measure Information:
Title
Is there a correlation between anthropometric measurements and balance in children with cerebral palsy?
Description
The purpose of the current study is to evaluate the correlation between anthropometric measurement (weight, height and BMI) and balance in children with cerebral palsy.
Time Frame
6 months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Their age will be ranged from 8 to 12 years.
The degree of their spasticity will be ranged from 1 to 2 according to Modified Ashworth' Scale.
They will be on level Ⅰ and Ⅱ on Growth Motor Function Classification System (GMFCS).
They will be able to stand without the use of an assistive device
Children can follow instructions and understand given orders.
Exclusion Criteria:
Severe visual or hearing impairment.
Fixed deformities or surgical interventions in the lower extremities.
Botulinum toxin injections in the last 6 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Walaa Abd El-Nabie
Phone
201115606185
Email
aigmanutd7@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gehan El meniawy
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walaa Abd El-Nabie
Phone
201115606185
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol and Statistical Analysis Plan
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
IPD will be shared with researchers
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Correlation Between Anthropometric Measurements And Balance IN Children With Cerebral Palsy
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