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CompletedNCT06642922BMIUpdated Oct 17, 2024

Gross Motor Abnormalities in Relation to Balance and Weight Indicators in Diplegia

An observational study in Spastic Diplegia Cerebral Palsy, sponsored by Lamis Neyazy Elrakhawy. Completed at 1 site in Egypt. Open to participants aged 5 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Lamis Neyazy Elrakhawy · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
104
Ages
5 Years to 10 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Spastic Diplegia Cerebral Palsy

Keywords

  • BMI
  • Balance
  • Gross motor capacities
  • obesity
  • diplegia
03

In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's enrollment of 104 is above the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

This is the only study on the registry with Lamis Neyazy Elrakhawy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

children with spastic diplegia aged from 5 to 10 years old

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

Exclusion Criteria:

  • Auditory defects.
  • Visual defects.
  • Cognitive or vestibular defects.
  • Use of an assistive device.
  • Fixed deformity, bony or joint limitation.
  • Surgery (tendon lengthening).
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
104 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. BMI

    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).

    Time frame: 9 months

  2. balance assessment

    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

    Time frame: 9 months

Secondary outcomes

  1. gross motor capacities

    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

    Time frame: 9 months

07

Study locations

1 site
  • Lamis Neyazy
    Giza, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06642922
Lead sponsor
Lamis Neyazy Elrakhawy
Responsible party
Lamis Neyazy Elrakhawy (principal investigator, Cairo University) — Sponsor-investigator
First posted
Oct 15, 2024
Start date
Oct 20, 2022
Primary completion
Jun 15, 2023
Completion
Jul 12, 2023
Last update
Oct 17, 2024

Study contacts

khaled A Mamdouh
principal investigator · Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Hoda A Eltalawy
study director · Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Radwa s Abdulrahman
study director · Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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