NCT06446986

Brief 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. 1.To compare dual task and upper extremity disability in individuals with AIS and healthy sex and age-matched healthy controls.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

June 6, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

May 31, 2024

Last Update Submit

December 10, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Multivariate analyses will be carried out with control variables

    baseline

Study Arms (2)

Study group

Patients with adolescent idiopathic scoliosis

Other: Single and Dual-Task Timed Up and Go TestOther: Single and Dual-Task Tandem Walking TestOther: Simple Shoulder Test

Control group

Age and sex matched healthy adolescent peers

Other: Single and Dual-Task Timed Up and Go TestOther: Single and Dual-Task Tandem Walking TestOther: Simple Shoulder Test

Interventions

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 groupStudy group

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.

Control groupStudy group

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: 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

Control groupStudy group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Adolescent Idiopathic Scoliosis

You may qualify if:

  • Patients diagnosed with Adolescent Idiopathic Scoliosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Elif D Durmaz

    Karaman Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor Dr, MD

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 6, 2024

Study Start

June 6, 2024

Primary Completion

February 26, 2025

Study Completion

February 26, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations