Scoliosis IdiopathicNCT06884150
fNIRS-based Analysis and Evaluation of the Effect of Schroth Rehabilitation on Motor Functions in Adolescent Idiopathic Scoliosis (AIS)
A study testing Exercise in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis; Adolescence
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 2 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being between the ages of 8-20
- Being diagnosed with adolescent idiopathic scoliosis,
- Accepting voluntary participation in the study.
Who cannot join
- 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,
Show all 9Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Scoliosis Idiopathic, Scoliosis; Adolescence
- Being tested
- Exercise
- Keywords
- fNIRS
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participating in schroth exercises for 45 minutes, 2 days a week after receiving the relevant diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 15 participant, healthy |
| Scoliosis group | Experimental | * Being between the ages of 8-16,
* Being diagnosed with adolescent idiopathic scoliosis, Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
fNIRs device
After the installation and testing of the FNIRS device, recording and analysis are performed.
Measured: Between 3th month-9th month
Y-balance test
Determination of maximum percentage reach and combined score from the Y-balance test,
Measured: Between 3th month-9th month
Secondary outcomes (1)
Scoliosis Research Society-22 (SRS-22)
Quality of life scale is determined with 5 sub-scores and a total score.
Measured: Between 3th month-9th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Oct 2024
- Primary completion2 Sep 2025 (estimated)
- Study completion2 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Control Group (healthy participants) Group 2: Scoliosis group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadriye Tombak, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884150
- Sponsor's protocol ID
- Akdeniz UniversityTombak
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A consent form will be obtained from the individuals participating in the study or their parents.
Publications
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.
PubMed 31082657
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fNIRS-based Analysis and Evaluation of the Effect of Schroth Rehabilitation on Motor Functions in Adolescent Idiopathic Scoliosis (AIS)
- ClinicalTrials.gov ID
- NCT06884150
- Acronym / sponsor ID
- Akdeniz UniversityTombak
- Conditions
- Scoliosis Idiopathic, Scoliosis; Adolescence
- Keywords
- fNIRS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 2 Jan 2026 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: Control Group (healthy participants) Group 2: Scoliosis group
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –15 participant, healthy |
| Scoliosis group | Experimental | Other: Exercise* Being between the ages of 8-16, * Being diagnosed with adolescent idiopathic scoliosis, |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Being between the ages of 8-20
- Being diagnosed with adolescent idiopathic scoliosis,
- Accepting voluntary participation in the study.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipating in schroth exercises for 45 minutes, 2 days a week after receiving the relevant diagnosis | Other | Scoliosis group |
Primary outcome
fNIRs device
Time frame: Between 3th month-9th month
After the installation and testing of the FNIRS device, recording and analysis are performed.
Y-balance test
Time frame: Between 3th month-9th month
Determination of maximum percentage reach and combined score from the Y-balance test,
1 secondary outcome
Scoliosis Research Society-22 (SRS-22)
Time frame: Between 3th month-9th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 31082657Surgent 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. A consent form will be obtained from the individuals participating in the study or their parents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fNIRs device (time frame: Between 3th month-9th month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06884150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.