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

NCT ID: NCT06642922

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-20

Study Completion Date

2023-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spastic Diplegia Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group 1

normal weight group , 53 participants BMI , balance , and gross motor capacities were assessed for each participant

No interventions assigned to this group

group 2

overweight and obese group , 51 participants BMI , balance , and gross motor capacities were assessed for each participant

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lamis Neyazy Elrakhawy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lamis Neyazy Elrakhawy

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

khaled A Mamdouh

Role: PRINCIPAL_INVESTIGATOR

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

Hoda A Eltalawy

Role: STUDY_DIRECTOR

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

Radwa s Abdulrahman

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lamis Neyazy

Giza, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

faculty of physical therapy

Identifier Type: REGISTRY

Identifier Source: secondary_id

P.T.REC/012/004585

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.