NCT06904157

Brief Summary

This study aims to investigate the effects of brace use on shoulder position, upper extremity proprioception, and upper extremity function in adolescents with idiopathic scoliosis. Participants will be assessed under both in-brace and out-brace conditions. The control group's upper extremity proprioception and upper extremity function will be assessed under out-brace condition. Shoulder position will be evaluated using a photographic method, while upper extremity proprioception (angular deviation) will be measured with the Laser Pointer-Assisted Angle Reproduction Test. Upper extremity function will be assessed through muscle strength tests, the Closed Kinetic Chain Upper Extremity Stability Test, the Medicine Ball Throw Test, the Finger-to-Nose Test, the Nellson Hand Reaction Test, and the Minnesota Manual Dexterity Test. Adolescents diagnosed with idiopathic scoliosis who have been prescribed brace treatment and have no history of spinal surgery or neurological/musculoskeletal conditions affecting upper extremity function will be included. Individuals with congenital or neuromuscular scoliosis, previous spinal surgery, neurological disorders affecting proprioception, or those unable to comply with study assessments will be excluded. This study aims to provide insights into the impact of bracing on proprioception and upper extremity function, contributing to the development of rehabilitation strategies for scoliosis management.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

February 27, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

February 27, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

ScoliosisBraceUpper ExtremityProprioceptionFunction

Outcome Measures

Primary Outcomes (4)

  • Cobb Angle Measurement

    Cobb angle, a standard measurement used to quantify spinal curvature in scoliosis, will be obtained from physician notes and radiographic images. A tangent will be drawn along the superior edge of the uppermost involved vertebra and the inferior edge of the lowest involved vertebra. Perpendicular lines will then be drawn, and the angle at their intersection will be recorded. Cobb angle will be measured both with and without bracing, and the difference will be noted. Unit of Measure: Degrees (°)

    Baseline and first week of brace use

  • Angle of Trunk Rotation (ATR)

    Trunk rotation will be assessed using a scoliometer during the Adams forward bending test. Participants will bend forward with arms hanging freely while the scoliometer will be placed perpendicularly on the spine and moved downward from the thoracic region. The highest degree of trunk rotation will be recorded. Unit of Measure: Degrees (°)

    Before brace application and 1 hour after brace application

  • Upper Extremity Proprioception Accuracy

    Proprioception will be assessed using the Laser Pointer-Assisted Angle Reproduction Test (LPAART) at 55°, 90°, and 125° in shoulder flexion and abduction. A laser pointer will be attached to the dominant wrist, and participants will position their arm to the designated angle with eyes open. After memorizing the position, they will attempt to replicate it with eyes closed. The deviation from the target angle will be recorded. Unit of Measure: Degrees (°) of deviation

    Before brace application and 1 hour after brace application

  • Anterior Humeral Head Position

    The anterior displacement of the humeral head relative to the acromion will be measured in two positions: (1) neutral shoulder position and (2) hands on hips (wrists extended, thumbs posterior). The distance between the anterior humeral head and the anterior acromion will be palpated, marked, photographed from 20 cm above, and measured in centimeters. Unit of Measure: Centimeters (cm)

    Before brace application and 1 hour after brace application

Secondary Outcomes (6)

  • Upper Extremity Muscle Strength

    Before brace application and 1 hour after brace application

  • Hand Dexterity (Minnesota Dexterity Test)

    Before brace application and 1 hour after brace application

  • Hand Reaction Time (Nelson Hand Reaction Test)

    Before brace application and 1 hour after brace application

  • Upper Extremity Coordination (Finger-to-Nose Test)

    Before brace application and 1 hour after brace application

  • Closed Kinetic Chain Upper Extremity Stability (CKCUES) Test

    Before brace application and 1 hour after brace application

  • +1 more secondary outcomes

Study Arms (2)

Patient Group

This group consists of individuals diagnosed with adolescent idiopathic scoliosis (AIS) who are using Cheneau-type braces. The age range for this group is 10-18 years. Participants must have a diagnosis of AIS, have been using a Cheneau-type brace for at least one month, have a primary thoracic or thoracolumbar curve, and a Cobb angle of 20 degrees or more. Additionally, the dominant hand must be the right hand, and participants must be willing to participate in the study with parental consent. Exclusion criteria include a diagnosis of congenital scoliosis, being a professional athlete, having a history of neuromuscular, rheumatological, renal, vestibular, pulmonary, or cardiovascular diseases unrelated to scoliosis, and a history of spinal surgery.

Control Group

This group consists of healthy adolescents without any scoliosis or spinal deformities. The age range for this group is 10-18 years. Participants must have a dominant right hand and be willing to participate in the study. Exclusion criteria include a history of neuromuscular, rheumatological, renal, vestibular, pulmonary, or cardiovascular diseases, a history of spinal surgery, and being a professional athlete.

Eligibility Criteria

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

This study will be carried out on adolescent idiopathic scoliosis individuals between the ages of 10-18 who have been using the brace prescribed by a physician for at least one month and age-matched healthy individuals. The corsets used by the individuals with scoliosis included in the study will be the previously prepared Cheneau type brace. Healthy individuals will be included in the study with the snowball method from the close environment of the individuals with scoliosis.

You may qualify if:

  • To have a diagnosis of adolescent idiopathic scoliosis (AIS),
  • Be using Cheneau Type corset for at least one month,
  • Having a primary thoracic or thoracolumbar curve,
  • Cobb angle of 20 degrees or more,
  • The dominant hand is the right hand,
  • Volunteering to participate in the study,
  • Individuals between the ages of 10-18
  • Dominant Hand is the Right Hand
  • Volunteering to Participate in the Study

You may not qualify if:

  • Having a diagnosis of Congenital Scoliosis,
  • Becoming a Professional Athlete,
  • Neuromuscular, Rheumatologic, Renal Except Scoliosis, Any History of Vestibular, Pulmonary or Cardiovascular Disease Finding
  • Neuromuscular, Rheumatologic, Renal, Vestibular, Pulmonary Or History of any Cardiovascular Disease
  • History of Spine Surgery,
  • Being a Professional Athlete.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University / Orthotics and Biomechanics Unit

Ankara, altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

KÜBRA NURDOĞAN, PT, MSc

CONTACT

Gözde Yağcı, Prof. Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 27, 2025

First Posted

April 1, 2025

Study Start

April 1, 2025

Primary Completion

May 30, 2025

Study Completion

June 30, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations