- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06446986
Dual Task Effect in Adolescent Idiopathic Scoliosis
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Karaman, Turkey (Türkiye), 70200
- Karaman Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed with Adolescent Idiopathic Scoliosis
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Patients with adolescent idiopathic scoliosis
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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.
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:
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.
|
|
Control group
Age and sex matched healthy adolescent peers
|
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.
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:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The difference in seconds of the Single and Dual-Task Timed Up and Go Test between study and control groups
Time Frame: baseline
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Univariate statistical analyses will be performed to calculate the differences in seconds between the study group and control group.
|
baseline
|
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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.
|
baseline
|
|
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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multivariate analyses will be carried out with control variables
Time Frame: baseline
|
Significant primary outcome measures will be controlled with:
|
baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Elif D Durmaz, Karaman Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01-2024/06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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