Adolescent Idiopathic ScoliosisNCT06141759
The Effect of Conservative Treatment on Perceptual and Cognitive Asymmetry in Scoliosis
A study testing Exercise in people with Adolescent Idiopathic Scoliosis, run by Bandırma Onyedi Eylül University at 2 sites in Turkey (Türkiye).
Trial summary
Adolescent idiopathic scoliosis (AIS) patients have been found to exhibit cortical asymmetry. This study aimed to examine the impact of conservative treatments on perceptual and cognitive asymmetry in the auditory system assessed by dichotic listening in AIS patients with thoracic major curves. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having been diagnosed with AIS,
- Being 10-16 years of age,
- Having a Cobb angle of between 20° and 50°
- Risser's sign of 0-3,
- Having right thoracic scoliosis,
- Being right-handed,
Show all 9Show fewer
- Having received no previous treatment that may affect scoliosis,
- Having no chronic disease requiring the use of medication.
- Participants aged 10-16 years
Who cannot join
- Having previous spinal operations,
- Hearing loss, or the presence of other muscular, neurological, or rheumatic diseases.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Burçin Akçay
Balıkesir, 10200
Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Balıkesir
About this study
Official title: The Effect of Schroth Best Practice Exercises and Cheneau Brace Treatment on Perceptual and Cognitive Asymmetry in Adolescent Idiopathic Scoliosis With Thoracic Major Curve
Adolescent idiopathic scoliosis (AIS) patients have been found to exhibit cortical asymmetry. This study aimed to examine the impact of conservative treatments on perceptual and cognitive asymmetry in the auditory system assessed by dichotic listening in AIS patients with thoracic major curves.
Read the detailed description
Background: Adolescent idiopathic scoliosis (AIS) patients have been found to exhibit cortical asymmetry. This study aimed to examine the impact of conservative treatments on perceptual and cognitive asymmetry in the auditory system assessed by dichotic listening in AIS patients with thoracic major curves. Method: This study involved 30 AIS patients and 21 healthy subjects. The intervention group used a Cheneau brace and performed 18 Schroth Best Practice (SBP) exercise sessions. Auditory lateralization was assessed using the Dichotic Listening Paradigm (DLP) in both groups before and after the intervention.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Cheneau brace and Schroth Best Practice exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Schroth Best Practice Exercises and Cheneau braces. There were 18 sessions, each lasting 90 minutes, a total of 6 weeks for the exercise training. Receives: Other: Exercise |
| Control Group | No intervention | For six weeks, no application was made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dichotic Listening Paradigm
The Dichotic Listening Paradigm is a method that provides behavioral information to determine auditory system asymmetry and is reliable for use with adolescents. The DLP was implemented in both groups at baseline and at the end of week 6 in a seated position with eyes open in a quiet room. In this paradigm, syllables ba, da, ga, pa, ta, and ka were utilized; these were standardized by the Dokuz Eylül University Music Sciences Voice Studio for Turkish society
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Jan 2023
- Primary completion1 Jul 2023
- Study completion10 Jul 2023
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 Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burçin Akçay, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141759
- Sponsor's protocol ID
- Bandırma University
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akcay B, Inanc G. The effect of Schroth Best Practice exercises and Cheneau brace treatment on perceptual and cognitive asymmetry in adolescent idiopathic scoliosis with thoracic major curve. Ir J Med Sci. 2024 Jun;193(3):1479-1486. doi: 10.1007/s11845-023-03593-2. Epub 2023 Dec 20.
PubMed 38123885
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Schroth Best Practice Exercises and Cheneau Brace Treatment on Perceptual and Cognitive Asymmetry in Adolescent Idiopathic Scoliosis With Thoracic Major Curve
- ClinicalTrials.gov ID
- NCT06141759
- Acronym / sponsor ID
- Bandırma University
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 21 Nov 2023 (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.
Adolescent idiopathic scoliosis (AIS) patients have been found to exhibit cortical asymmetry. This study aimed to examine the impact of conservative treatments on perceptual and cognitive asymmetry in the auditory system assessed by dichotic listening in AIS patients with thoracic major curves.
Detailed description
Background: Adolescent idiopathic scoliosis (AIS) patients have been found to exhibit cortical asymmetry. This study aimed to examine the impact of conservative treatments on perceptual and cognitive asymmetry in the auditory system assessed by dichotic listening in AIS patients with thoracic major curves. Method: This study involved 30 AIS patients and 21 healthy subjects. The intervention group used a Cheneau brace and performed 18 Schroth Best Practice (SBP) exercise sessions. Auditory lateralization was assessed using the Dichotic Listening Paradigm (DLP) in both groups before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: ExerciseSchroth Best Practice Exercises and Cheneau braces. There were 18 sessions, each lasting 90 minutes, a total of 6 weeks for the exercise training. |
| Control Group | No intervention | –For six weeks, no application was made. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Having been diagnosed with AIS,
- Being 10-16 years of age,
- Having a Cobb angle of between 20° and 50°
- Risser's sign of 0-3,
- Having right thoracic scoliosis,
Key exclusion criteria (2 listed)
- Having previous spinal operations,
- Hearing loss, or the presence of other muscular, neurological, or rheumatic diseases.
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 |
|---|---|---|
| ExerciseCheneau brace and Schroth Best Practice exercise | Other | Intervention group |
Primary outcome
Dichotic Listening Paradigm
Time frame: 6 weeks
The Dichotic Listening Paradigm is a method that provides behavioral information to determine auditory system asymmetry and is reliable for use with adolescents. The DLP was implemented in both groups at baseline and at the end of week 6 in a seated position with eyes open in a quiet room. In this paradigm, syllables ba, da, ga, pa, ta, and ka were utilized; these were standardized by the Dokuz Eylül University Music Sciences Voice Studio for Turkish society
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Derived from this study: PubMed 38123885Akcay B, Inanc G. The effect of Schroth Best Practice exercises and Cheneau brace treatment on perceptual and cognitive asymmetry in adolescent idiopathic scoliosis with thoracic major curve. Ir J Med Sci. 2024 Jun;193(3):1479-1486. doi: 10.1007/s11845-023-03593-2. Epub 2023 Dec 20.
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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.
2 sites 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 Adolescent Idiopathic Scoliosis, run by Bandırma Onyedi Eylül University at 2 sites 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dichotic Listening Paradigm (time frame: 6 weeks). 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 NCT06141759, 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 21 Nov 2023.