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

NCT06642922 | Completed DMC

• 2 other identifiers: P.T.REC/012/004585faculty of physical therapy
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Spastic Diplegia Cerebral Palsy

Keywords

BMI; Balance; Gross motor capacities; obesity; diplegia

Outcome Measures

Primary Outcomes (2)

• 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).

  9 months

• 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

  9 months

Secondary Outcomes (1)

• gross motor capacities

  9 months

Study Arms (2)

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

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children with spastic diplegia aged from 5 to 10 years old

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Lamis Neyazy Elrakhawy: lead

Study Sites (1)

Lamis Neyazy

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebral palsy, spastic, diplegic; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• khaled A Mamdouh

  Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 20, 2022
• Primary Completion: June 15, 2023
• Study Completion: July 12, 2023
• Last Updated: October 17, 2024

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)