NCT06884150

Brief Summary

This study investigates the effects of Schroth-based rehabilitation on cortical dynamics, body awareness, and quality of life in individuals with Adolescent Idiopathic Scoliosis (AIS). Using fNIRS technology, motor control processes will be monitored, and the impact of rehabilitation on brain activity will be assessed. A total of 30 participants (15 healthy and 15 with AIS), aged 8-16, will be examined, with pre- and post-rehabilitation comparisons. Measurements will include static posture, Y-Balance Test, Schroth walking, and brain activity recordings. SPM analysis will be used to assess brain signals, and quality of life and cosmetic deformity perception will be statistically evaluated. The findings will contribute to the integration of neuroimaging into rehabilitation assessment, helping to develop more effective treatment strategies.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

October 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2026

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

March 13, 2025

Last Update Submit

March 13, 2025

Conditions

Keywords

fNIRS

Outcome Measures

Primary Outcomes (2)

  • fNIRs device

    After the installation and testing of the FNIRS device, recording and analysis are performed.

    Between 3th month-9th month

  • Y-balance test

    Determination of maximum percentage reach and combined score from the Y-balance test,

    Between 3th month-9th month

Secondary Outcomes (1)

  • Scoliosis Research Society-22 (SRS-22)

    Between 3th month-9th month

Study Arms (2)

Control group

NO INTERVENTION

15 participant, healthy

Scoliosis group

EXPERIMENTAL

* Being between the ages of 8-16, * Being diagnosed with adolescent idiopathic scoliosis,

Other: Exercise

Interventions

Participating in schroth exercises for 45 minutes, 2 days a week after receiving the relevant diagnosis

Scoliosis group

Eligibility Criteria

Age8 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being between the ages of 8-20
  • Being diagnosed with adolescent idiopathic scoliosis,
  • Accepting voluntary participation in the study.

You may not qualify if:

  • History of tumor, vertebral malformation, trauma, epilepsy,
  • Having had spine or lower extremity surgery,
  • Having diagnosed psychiatric problems,
  • Having any disease that would prevent them from exercising,
  • Having rheumatic disease,
  • Having congenital deformity,
  • Being on another treatment for scoliosis during the study period,
  • Having received any conservative treatment for scoliosis or posture disorder in the last six months,
  • Having a body mass index over 25,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (1)

  • Surgent OJ, Dadalko OI, Pickett KA, Travers BG. Balance and the brain: A review of structural brain correlates of postural balance and balance training in humans. Gait Posture. 2019 Jun;71:245-252. doi: 10.1016/j.gaitpost.2019.05.011. Epub 2019 May 6.

    PMID: 31082657BACKGROUND

Related Links

MeSH Terms

Conditions

Scoliosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Group 1: Control Group (healthy participants) Group 2: Scoliosis group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 19, 2025

Study Start

October 1, 2024

Primary Completion

September 2, 2025

Study Completion

January 2, 2026

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

A consent form will be obtained from the individuals participating in the study or their parents.

Shared Documents
ICF
Time Frame
Between 3th month-9th month

Locations