NCT06812013

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2025

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

January 13, 2025

Last Update Submit

May 8, 2025

Conditions

Keywords

foot printscoliosisbalance

Outcome Measures

Primary Outcomes (2)

  • static and dynamic balance

    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

    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

Study Arms (2)

healthy adolescents

healthy adolescents

Other: assessment of foot print and balance

study group

adolescents with scoliosis

Other: assessment of foot print and balance

Interventions

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.

healthy adolescentsstudy group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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°

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Modern University for Technology and Information

Cairo, Egypt

Location

Related Links

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor hanan hosny M Battesha

Study Record Dates

First Submitted

January 13, 2025

First Posted

February 6, 2025

Study Start

February 10, 2025

Primary Completion

May 5, 2025

Study Completion

May 8, 2025

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations