Dual Tasking and Upper Extremity Disability in Adolescent Idiopathic Scoliosis

Scoliosis Idiopathic Clinical Trial

Official title:

Clinical and Radiological Markers of Dual Tasking and Upper Extremity Disability in Adolescent Idiopathic Scoliosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446986
• Other study ID #: E-11095095-050.04-181580
• Status: Recruiting
• Start date: June 6, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Karamanoglu Mehmetbey University
• Contact: Aynur Basaran, MD, Prof
• Phone: +90 338 226 3225
• Email: aynurbasaran[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). The main questions it aims to answer are:

1. To compare dual task and upper extremity disability in individuals with AIS and healthy sex and age-matched healthy controls.

2. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

Intervention

Other:
• Single and Dual-Task Timed Up and Go Test
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 Test
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 Test
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.

Locations

Country	Name	City	State
Turkey	Karaman Training and Research Hospital	Karaman

Sponsors (2)

Lead Sponsor	Collaborator
Karamanoglu Mehmetbey University	Karaman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	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.	baseline
Primary	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.	baseline
Secondary	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).	baseline