fNIRS-based Analysis and Evaluation of the Effect of Schroth Rehabilitation on Motor Functions in Adolescent Idiopathic Scoliosis (AIS)

March 13, 2025 updated by: Kadriye Tombak, Akdeniz University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The evaluation of body schema and perception in the cortex of adolescent idiopathic scoliosis and the analysis of changes in brain regions functionally related to motor control and coordination between controls and the analysis of their developmental process with rehabilitation are very important in terms of contributing to the planning of a better effective rehabilitation process, increasing the patient's quality of life and evaluating the status of body representation related to the disease, its development and sustainability in daily life.

fNIRS-based postural control neuroimaging and analysis will provide pioneering information about body schema, postural balance, motor activation and their rehabilitation-oriented changes and brain plasticity, which will provide separate analysis of dynamic and static balance.

The changes created by body schema and perception in the cortex in individuals with AIS and the rehabilitation-oriented developmental process will be evaluated with functional near-infrared spectroscopy (fNIRS) solutions, specifically in motor control and coordination.

Another important deficiency in the literature is the evaluation of changes created by rehabilitation processes in the cortex. Thanks to neural plasticity, a system that tries to compensate for a dysfunction can be reorganized. Therefore, rehabilitation studies are also of great importance here. The observed significant lateralization and body schema changes may also be useful for creating personalized and targeted corrective postural exercises.

The portable fNIRS device is an effective neuroimaging and analysis method for monitoring motor control processes in cortical areas in subjects moving without any movement restrictions. Therefore, especially in terms of body representation, since performing measurements in a limited area where the patient's movement is not possible, such as fMRI, does not provide very accurate results, especially since the evaluation of the change process created by motor movements in the cortex does not yield very accurate results, cortical dynamics in AIS individuals will be evaluated with fNIRS.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

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

  • Turkey
      • Antalya, Turkey, 07100
        • Akdeniz University

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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,

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
15 participant, healthy
Experimental: Scoliosis group
  • Being between the ages of 8-16,
  • Being diagnosed with adolescent idiopathic scoliosis,
Other: Exercise
Participating in schroth exercises for 45 minutes, 2 days a week after receiving the relevant diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fNIRs device
Time Frame: Between 3th month-9th month
After the installation and testing of the FNIRS device, recording and analysis are performed.
Between 3th month-9th month
Y-balance test
Time Frame: Between 3th month-9th month
Determination of maximum percentage reach and combined score from the Y-balance test,
Between 3th month-9th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scoliosis Research Society-22 (SRS-22)
Time Frame: Between 3th month-9th month
Quality of life scale is determined with 5 sub-scores and a total score.
Between 3th month-9th month

Collaborators and Investigators

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

Sponsor

Akdeniz University

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.

General Publications

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)

October 1, 2024

Primary Completion (Estimated)

September 2, 2025

Study Completion (Estimated)

January 2, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Akdeniz UniversityTombak

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

Between 3th month-9th month

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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