Scoliosis IdiopathicNCT06446986
Dual Task Effect in Adolescent Idiopathic Scoliosis
An observational study of Scoliosis Idiopathic, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in adolescent idiopathic scoliosis (AIS). Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- Single and Dual-Task Timed Up and Go Test, Single and Dual-Task Tandem Walking Test and Simple Shoulder Test
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2024to 26 Feb 2025
- Phase
- Observational
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescent Idiopathic Scoliosis
Who may be able to join
- Patients diagnosed with Adolescent Idiopathic Scoliosis
Who cannot join
- Patients with complaints of neck, back, and shoulder pain
- Having a known neurological or systemic disease
- Having cognitive dysfunction that cannot cooperate with evaluations
- Having undergone musculoskeletal surgery or injury
- Extremity length difference of more than 1 cm
- Regular repetitive overhead shoulder movements related to professional or sports activities
- BMI >30 kg/m2
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
The goal of this observational study is to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in adolescent idiopathic scoliosis (AIS). The main questions it aims to answer are:
- To compare dual task and upper extremity disability in individuals with AIS and healthy sex and age-matched healthy controls.
- To analyze the relationship of dual-task and upper extremity disability in individuals with AIS with clinical and radiological parameters All participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. Besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity and sagittal plane changes are accompanied by coronal plane changes. As a result of spinal deformity, morphological changes occur in the trunk and rib cage, and the relationships between body parts are affected. Considering the anatomical proximity between the scapula and the rib cage, alteration of the shoulder and upper extremity functions as a consequence of the change in proximal orientation is expected.
On the other hand, maintaining postural control depends on the dynamic relationship between sensory information and motor output. Dual tasking is an experience-based neurophysiological process that requires a person to perform two tasks simultaneously. When a person has problems with the neurophysiological process, the performance of one or both functions is negatively affected.
This observational study aims to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in AIS. All participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. Besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.
- Conditions
- Scoliosis Idiopathic
- Being tested
- Single and Dual-Task Timed Up and Go Test, Single and Dual-Task Tandem Walking Test, Simple Shoulder Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single and Dual-Task Timed Up and Go TestOther
Timed Up and Go Test will be conducted. Then, for motor-motor dual-task evaluation, the test will be repeated while the subjects carry a tray containing 4 glasses of water without spilling the water. The time required to complete each test will be recorded in seconds.
Single and Dual-Task Tandem Walking TestOther
The tandem walking test will be performed. Then, for cognitive-motor dual-task tandem walking test assessment, the test will be repeated while the subject completes one of 3 different cognitive tasks. These cognitive tasks used during dual-task trials will be switched between trials in an attempt to avoid a practice effect. The time required to complete each test will be recorded in seconds.
The cognitive tasks are as follows:
- Counting down by six or seven from a randomly presented 2-digit number
- Counting backward the months starting from a randomly selected month
- Spelling a five-letter word backwards
Simple Shoulder TestOther
Simple Shoulder Test contains 12 items and rates pain and function in patients with shoulder problems. Each item has two options and is scored either ''1 = yes'' or ''0 = no''. The total score ranges from 0 to 12. Higher scores indicate better physical functions.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with adolescent idiopathic scoliosis Receives: Other: Single and Dual-Task Timed Up and Go Test; Other: Single and Dual-Task Tandem Walking Test; Other: Simple Shoulder Test | |
| Control group | Age and sex matched healthy adolescent peers Receives: Other: Single and Dual-Task Timed Up and Go Test; Other: Single and Dual-Task Tandem Walking Test; Other: Simple Shoulder Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in seconds of the Single and Dual-Task Timed Up and Go Test between study and control groups
Univariate statistical analyses will be performed to calculate the differences in seconds between the study group and control group.
Measured: baseline
The difference in seconds of the Single and Dual-Task Tandem Walking Test between study and control groups
Univariate statistical analyses will be performed to calculate the differences in seconds between the study group and control group.
Measured: baseline
The difference of the Simple Shoulder Test scores between study and control groups
Univariate statistical analyses will be performed to calculate the differences in the scores between the study group and control group.
Measured: baseline
Secondary outcomes (1)
Multivariate analyses will be carried out with control variables
Significant primary outcome measures will be controlled with:
- Clinical parameters:
- Scapular dyskinesia evaluation (present/absent)
- Lateral scapular shift test (positive/negative)
- TRACE score (Trunk Aesthetic Clinical Evaluation) (score ranges from 0 to12)
- Thoracic expansion (cm)
- Radiological parameters: Coronal plan:
- Curve type (single, double major),
- Location of curvature (Thoracic, thoracolumbar, lumbar),
- Majör curve side (right/left),
- Major curve Cobb angle (degrees),
- Coronal balance (mm),
- Apical vertebrae translation (mm),
- Apical vertebrae rotation (Grade from 0 to 4),
- Pelvic obliquity (degrees),
- Radiographic shoulder height (mm),
- Radiological parameters: Sagital plan
- Torasik kyphosis Cobb angle (degrees),
- Lumbar lordosis Cobb angle (degrees),
- Sagittal balance (mm),
- Pelvic tilt (degrees),
- Sacral slope (degrees),
- Pelvic incidence (degrees).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start6 Jun 2024
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Responsible party
- Principal investigator, Aynur Başaran, Karamanoğlu Mehmetbey University
- Investigators
- Elif D Durmaz, Study chair, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446986
- Sponsor's protocol ID
- 01-2024/06
- Status last verified
- Dec 2025
- First submitted
- 31 May 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Task Effect in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06446986
- Acronym / sponsor ID
- 01-2024/06
- Conditions
- Scoliosis Idiopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 6 Jun 2024 (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.
The goal of this observational study is to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in adolescent idiopathic scoliosis (AIS). The main questions it aims to answer are:
- To compare dual task and upper extremity disability in individuals with AIS and healthy sex and age-matched healthy controls.
- To analyze the relationship of dual-task and upper extremity disability in individuals with AIS with clinical and radiological parameters All participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. Besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity and sagittal plane changes are accompanied by coronal plane changes. As a result of spinal deformity, morphological changes occur in the trunk and rib cage, and the relationships between body parts are affected. Considering the anatomical proximity between the scapula and the rib cage, alteration of the shoulder and upper extremity functions as a consequence of the change in proximal orientation is expected.
On the other hand, maintaining postural control depends on the dynamic relationship between sensory information and motor output. Dual tasking is an experience-based neurophysiological process that requires a person to perform two tasks simultaneously. When a person has problems with the neurophysiological process, the performance of one or both functions is negatively affected.
This observational study aims to evaluate the dual task and upper extremity disability in individuals with adolescent idiopathic scoliosis compared to healthy controls and to examine their relationship with clinical and radiological parameters in AIS. All participants' dual-task performance will be evaluated and they will answer the upper extremity disability survey. Besides, the study groups will be examined thoroughly and radiological parameters will be calculated to identify the clinical and radiological parameters that affect dual-task performance and upper extremity disability.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Single and Dual-Task Timed Up and Go Test, Other: Single and Dual-Task Tandem Walking Test, Other: Simple Shoulder TestPatients with adolescent idiopathic scoliosis |
| Control group | – | Other: Single and Dual-Task Timed Up and Go Test, Other: Single and Dual-Task Tandem Walking Test, Other: Simple Shoulder TestAge and sex matched healthy adolescent peers |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescent Idiopathic Scoliosis
Key inclusion criteria (1 listed)
- Patients diagnosed with Adolescent Idiopathic Scoliosis
Key exclusion criteria (7 listed)
- Patients with complaints of neck, back, and shoulder pain
- Having a known neurological or systemic disease
- Having cognitive dysfunction that cannot cooperate with evaluations
- Having undergone musculoskeletal surgery or injury
- Extremity length difference of more than 1 cm
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 |
|---|---|---|
| Single and Dual-Task Timed Up and Go TestTimed Up and Go Test will be conducted. Then, for motor-motor dual-task evaluation, the test will be repeated while the subjects carry a tray containing 4 glasses of water without spilling the water. The time required to complete each test will be recorded in seconds. | Other | Control group, Study group |
| Single and Dual-Task Tandem Walking TestThe tandem walking test will be performed. Then, for cognitive-motor dual-task tandem walking test assessment, the test will be repeated while the subject completes one of 3 different cognitive tasks. These cognitive tasks used during dual-task trials will be switched between trials in an attempt to avoid a practice effect. The time required to complete each test will be recorded in seconds. The cognitive tasks are as follows: 1. Counting down by six or seven from a randomly presented 2-digit number 2. Counting backward the months starting from a randomly selected month 3. Spelling a five-letter word backwards | Other | Control group, Study group |
| Simple Shoulder TestSimple Shoulder Test contains 12 items and rates pain and function in patients with shoulder problems. Each item has two options and is scored either ''1 = yes'' or ''0 = no''. The total score ranges from 0 to 12. Higher scores indicate better physical functions. | Other | Control group, Study group |
Primary outcome
The difference in seconds of the Single and Dual-Task Timed Up and Go Test between study and control groups
Time frame: baseline
Univariate statistical analyses will be performed to calculate the differences in seconds between the study group and control group.
The difference in seconds of the Single and Dual-Task Tandem Walking Test between study and control groups
Time frame: baseline
Univariate statistical analyses will be performed to calculate the differences in seconds between the study group and control group.
The difference of the Simple Shoulder Test scores between study and control groups
Time frame: baseline
Univariate statistical analyses will be performed to calculate the differences in the scores between the study group and control group.
1 secondary outcome
Multivariate analyses will be carried out with control variables
Time frame: baseline
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 18 Dec 2025.
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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.
Elif D Durmaz study chair
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic, run by Karamanoğlu Mehmetbey 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 1 inclusion and 7 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 18 Dec 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?
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?
The difference in seconds of the Single and Dual-Task Timed Up and Go Test between study and control groups (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025.