Gross Motor Abnormalities in Relation to Balance and Weight Indicators in Diplegia (BMI)

October 15, 2024 updated by: Lamis Neyazy Elrakhawy

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

Completed

Detailed Description

Spastic diplegia is the most common type of CP that results in problems with posture, balance, as well as gait control. For children suffering from spastic diplegic CP, balance problems provide a significant difficulty since they make it difficult for them to achieve and maintain balance . Additionally, they commonly demonstrate delayed development of gross motor function that has been connected to functional outcomes, such as daily living tasks . The prevalence of obesity in the CP population has risen over the last decade from 7.7 to 16.5 %. . Obesity is associated with health risks and difficulties in balance and walking. this cross-sectional-correlation study was conducted at the Outpatient Clinic at the Faculty of Physical Therapy, Cairo University. The study included 104 diplegic children aged from 5-10 years, 53 in normal weight group and 51 in overweight group. Dynamic balance was evaluated by overall stability index (OSI) in biodex balance system and gross motor capacities (GMC) were evaluated by standing &walking dimensions in GMFM

Study Type

Observational

Enrollment (Actual)

104

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

      • Giza, Egypt
        • Lamis Neyazy

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children with spastic diplegia aged from 5 to 10 years old

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

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

Cohorts and Interventions

Group / Cohort
group 1
normal weight group , 53 participants BMI , balance , and gross motor capacities were assessed for each participant
group 2
overweight and obese group , 51 participants BMI , balance , and gross motor capacities were assessed for each participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 9 months
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).
9 months
balance assessment
Time Frame: 9 months
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
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gross motor capacities
Time Frame: 9 months
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
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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)

October 20, 2022

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

July 12, 2023

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 13, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Spastic Diplegia Cerebral Palsy

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