Impact of Idiopathic Scoliosis on Balance and Footprint Symmetry in Adolescents

May 8, 2025 updated by: Hanan Hosny M Battesha, Al-Zaytoonah University of Jordan
Adolescent idiopathic scoliosis (AIS) is the most prevalent form of scoliosis that affects children after the age of 10 years and is considered a critical developmental stage of the musculoskeletal system of the child. AIS causes deviations in the CNS, leading to asymmetry of motor activity and, consequently, an incorrect position of the spine. The progressive deformation of the spine leads to increased asymmetry in body functions. This elevated asymmetry is understood by the nervous system as a norm, which causes children to cease to sense the correct body position that may affect both static and dynamic balance and the foot pressure symmetry of the child, which was not investigated in such cases in any previous studies till now.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

150

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

      • Cairo, Egypt
        • Modern University for Technology and Information

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
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Study population & Sample size: One hundred and fifty adolescents will be recruited to participate in the study, seventy-five of them will be healthy adolescents while the other Seventy-five adolescents will have idiopathic scoliosis with different degrees of scoliosis curves.

Description

Inclusion Criteria:

  • Asymptomatic children and adolescents ages 10 to 18 years
  • confirmed through X-rays; we focused on patients in growing age.
  • adolescent idiopathic scoliosis that has a Cobb angle of 10° to 50°

Exclusion Criteria:

  • Neuromuscular etiology (e.g., cerebral palsy, myelomeningocele, muscular dystrophy, spinal muscular atrophy, spina bifida, spinal cord injuries)
  • Early-onset idiopathic etiology (infantile [ages 0 to 3 years] or juvenile [ages 4 to 9 years])
  • Congenital etiology (e.g., hemivertebrae, failure of segmentation) Mesenchymal/syndromic etiology (e.g., Marfan syndrome, mucopolysaccharidosis, osteogenesis imperfecta, inflammatory diseases, postoperative)

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
Intervention / Treatment
healthy adolescents

For static and dynamic balance assessment, Biodex Medical Systems Inc., Shirley, New York, USA (serial n.: 13020193) was used. The device consists of a circular foot platform that permits tilting in all directions, height-adjustable support rails, height adjustable display screen, and a printer. Balance assessment by the Biodex system is a valid and reliable objective measurement.

For assessment of foot print symmetry Tekscan HR walkway Mat™ pressure measurement system, Tekscan Inc. USA will be use. It is made up of a digital mat inserted into a wooden walkway, sensors (4 senses/cm2) embedded in the mat, and a computer running the Tekscan Software (version 7) for data extrapolation.

study group
adolescents with scoliosis

For static and dynamic balance assessment, Biodex Medical Systems Inc., Shirley, New York, USA (serial n.: 13020193) was used. The device consists of a circular foot platform that permits tilting in all directions, height-adjustable support rails, height adjustable display screen, and a printer. Balance assessment by the Biodex system is a valid and reliable objective measurement.

For assessment of foot print symmetry Tekscan HR walkway Mat™ pressure measurement system, Tekscan Inc. USA will be use. It is made up of a digital mat inserted into a wooden walkway, sensors (4 senses/cm2) embedded in the mat, and a computer running the Tekscan Software (version 7) for data extrapolation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
static and dynamic balance
Time Frame: 2 months
For static and dynamic balance assessment, Biodex Medical Systems Inc., Shirley, New York, USA (serial n.: 13020193) was used. The device consists of a circular foot platform that permits tilting in all directions, height-adjustable support rails, height adjustable display screen, and a printer. Balance assessment by the Biodex system is a valid and reliable objective measurement.
2 months
foot print
Time Frame: 2 months
For assessment of foot print symmetry Tekscan HR walkway Mat™ pressure measurement system, Tekscan Inc. USA will be use. It is made up of a digital mat inserted into a wooden walkway, sensors (4 senses/cm2) embedded in the mat, and a computer running the Tekscan Software (version 7) for data extrapolation.
2 months

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

February 10, 2025

Primary Completion (Actual)

May 5, 2025

Study Completion (Actual)

May 8, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

February 1, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 8, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Scoliosis

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.

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