- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06141759
The Effect of Conservative Treatment on Perceptual and Cognitive Asymmetry in Scoliosis
November 17, 2023 updated by: Burçin Akçay, Bandırma Onyedi Eylül University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
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
-
-
-
Balıkesir, Turkey
- Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
-
Balıkesir, Turkey, 10200
- Burçin Akçay
-
-
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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria for Intervention Group:
- 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,
- Having received no previous treatment that may affect scoliosis,
- Having no chronic disease requiring the use of medication.
Inclusion Criteria for Intervention Group:
- Participants aged 10-16 years
Exclusion Criteria for both groups:
- Having previous spinal operations,
- Hearing loss, or the presence of other muscular, neurological, or rheumatic diseases.
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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Schroth Best Practice Exercises and Cheneau braces.
There were 18 sessions, each lasting 90 minutes, a total of 6 weeks for the exercise training.
|
Cheneau brace and Schroth Best Practice exercise
|
No Intervention: Control Group
For six weeks, no application was made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2023
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
July 10, 2023
Study Registration Dates
First Submitted
November 14, 2023
First Submitted That Met QC Criteria
November 17, 2023
First Posted (Estimated)
November 21, 2023
Study Record Updates
Last Update Posted (Estimated)
November 21, 2023
Last Update Submitted That Met QC Criteria
November 17, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bandırma University
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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