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Completed

NCT Number: NCT06642922

Gross Motor Abnormalities in Relation to Balance and Weight Indicators in 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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Lamis Neyazy Elrakhawy

Other

Registry information

Official study title

Correlation Between BMI , Balance and Gross Motor Capacities in Children with Spastic Diplegia

Acronym: BMI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2024
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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