NCT05187780

Brief Summary

The aim of the study is to compare the spine joint reposition sense in adolescent idiopathic scoliosis and healthy adolescents and to investigate whether there is a difference.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

January 22, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

December 24, 2021

Last Update Submit

August 3, 2022

Conditions

Keywords

scoliosisproprioceptionspine

Outcome Measures

Primary Outcomes (1)

  • Evaluation of spine joint position reproduction

    Acumar™ Dual Inclinometer: The subjects will be asked to stay at the reference position for three seconds and then move to the upright position and then go back to the reference angle with their eyes closed. The absolute difference between the two positions in degrees will be noted as the reposition error value. The decrease in the reposition error value is considered as the improvement in the reposition sense.

    Baseline

Secondary Outcomes (5)

  • Spinal pain assessment

    Baseline

  • Physical activity level

    Baseline

  • Adam's Forward Bending Test

    Baseline

  • Cobb angle assessment

    Baseline

  • Flexicurve ruler

    Baseline

Study Arms (3)

Group 1

Adolescents with Idiopathic Scoliosis who have 10⁰-24⁰ Cobb angles

Group 2

Adolescents with Idiopathic Scoliosis who have 25⁰-40⁰ Cobb angles

Group 3

Healthy adolescents without scoliosis as controls

Eligibility Criteria

Age10 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adolescents with a diagnosis of idiopathic scoliosis between the ages of 10-19, living in Istanbul and their healthy peers will be included in the study. The subjects will be divided into 3 groups: Group 1: Subjects with AIS with 10⁰-24⁰ Cobb angle, Group 2: Subjects with AIS with 25⁰-40⁰ Cobb angle, Group 3: Healthy adolescents in the same age group (control group).

You may qualify if:

  • Being between the ages of 10 and 19 years
  • Having a Cobb angle of 10-40 degrees measured on the anteroposterior radiograph or a healthy spine alignment (Forward Bend Test \< 5⁰ (negative) and Flexicurve Kyphosis Index ≤13)
  • No previous conservative approach to scoliosis
  • Volunteer to participate in the study

You may not qualify if:

  • Concomitant mental problem, rheumatological, neuromuscular, cardiovascular, pulmonary history
  • Any orthopedic disability or severe pain that would preclude evaluations
  • Musculoskeletal injury related to the spine in the last 3 months
  • Having had spine surgery
  • Presence of tumor in the spine
  • Loss of vision and/or hearing/presence of vestibular problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Ayşe Zengin Aplözgen, PhD

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Begüm KARA KAYA, MSc

CONTACT

Ayşe Zengin Aplözgen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 24, 2021

First Posted

January 12, 2022

Study Start

January 22, 2022

Primary Completion

September 22, 2022

Study Completion

November 22, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations