Adolescent Idiopathic Scoliosis (AIS)NCT06904157
Investigation of Shoulder Position, Upper Extremity Proprioception, and Function in Adolescents With Idiopathic Scoliosis Using Braces
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by Gözde Yagci (Gür) at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Inclusion criteria for the patient group;
- 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,
Show all 11Show fewer
- Volunteering to participate in the study,
- Parental consent was required. Inclusion criteria for the control group;
- Individuals between the ages of 10-18
- Dominant Hand is the Right Hand
- Volunteering to Participate in the Study
Who cannot join
- Having a diagnosis of Congenital Scoliosis,
- Becoming a Professional Athlete,
- Neuromuscular, Rheumatologic, Renal Except Scoliosis, Any History of Vestibular, Pulmonary or Cardiovascular Disease Finding
- History of Surgical Intervention on the Spine. Exclusion Criteria for Control Group;
- Neuromuscular, Rheumatologic, Renal, Vestibular, Pulmonary Or History of any Cardiovascular Disease
- History of Spine Surgery,
- Being a Professional Athlete.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University / Orthotics and Biomechanics Unit
Ankara, altındağ, 06100
Fatih Erbahçeci, Prof. Dr., +90 312 305 15 76, ftr@hacettepe.edu.tr
Gözde YAĞCI, Prof., +90 507 427 43 51, gozdeyg8@gmail.com
About this study
Official title: Investigation of Shoulder Head Position, Upper Extremity Proprioception, and Upper Extremity Function in Adolescents With Idiopathic Scoliosis Using Braces
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.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional spinal deformity characterized by lateral curvature and vertebral rotation, affecting postural alignment, musculoskeletal function, and neuromuscular control. AIS can lead to asymmetrical loading of the spine and trunk, potentially altering proprioception, postural stability, and functional capacity. Bracing is a widely used conservative treatment aimed at preventing curve progression and maintaining spinal alignment during skeletal growth. However, its effects on upper extremity function, proprioception, and shoulder biomechanics remain underexplored.
Proprioception, the body's ability to sense movement and position, plays a critical role in motor control and stability. In AIS, spinal asymmetry and altered postural alignment may disrupt proprioceptive feedback mechanisms, leading to compensatory movement strategies and potential impairments in upper extremity coordination and function. Additionally, bracing may impose external constraints that influence neuromuscular activation patterns and joint positioning, further affecting movement efficiency and functional performance.
This study aims to investigate the impact of brace use on shoulder position, upper extremity proprioception, and functional performance in adolescents with idiopathic scoliosis. Participants will be assessed in both braced and unbraced conditions to determine how brace-related mechanical constraints influence proprioceptive accuracy, postural adaptation, and functional motor skills. Shoulder position will be analyzed through photographic assessment, while proprioception will be measured using the Laser Pointer-Assisted Angle Reproduction Test. Upper extremity function will be evaluated using standardized clinical assessments, including strength tests, stability and coordination measures, and reaction time assessments.
Understanding the effects of bracing on upper extremity proprioception and function is essential for optimizing rehabilitation strategies in AIS. This study seeks to provide evidence that can inform clinical decision-making regarding brace design, therapy interventions, and functional training approaches to minimize movement restrictions and enhance musculoskeletal performance in adolescents undergoing brace treatment.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Scoliosis, Brace, Upper Extremity, Proprioception, Function
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (°)
Measured: 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 (°)
Measured: 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
Measured: 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)
Measured: Before brace application and 1 hour after brace application
Secondary outcomes (6)
Upper Extremity Muscle Strength
Isometric muscle strength of shoulder and elbow muscles will be assessed using a digital dynamometer (Power Track). Each test will be performed three times, and the highest value will be recorded in Newtons (N). Strength tests will include shoulder elevation (upper trapezius), flexion, abduction, internal and external rotation, elbow flexion, and extension.
Unit of Measure: Newtons (N)
Measured: Before brace application and 1 hour after brace application
Hand Dexterity (Minnesota Dexterity Test)
Hand dexterity will be assessed using the Minnesota Hand Dexterity Test, which includes two timed tasks: (1) placing disks in holes and (2) rotating disks. The total completion time will be recorded.
Unit of Measure: Seconds (s)
Measured: Before brace application and 1 hour after brace application
Hand Reaction Time (Nelson Hand Reaction Test)
Reaction time will be measured using the Nelson Hand Reaction Test, where participants will catch a dropped ruler between their thumb and index finger. The distance (cm) the ruler falls before being caught will be converted into reaction time using the formula: Reaction Time = √(2 × Distance / 980 ms²). The best and worst trials will be excluded, and the average of three trials will be recorded.
Unit of Measure: Milliseconds (cm/ms)
Measured: Before brace application and 1 hour after brace application
Upper Extremity Coordination (Finger-to-Nose Test)
Coordination will be assessed using the finger-to-nose test. Participants will touch their nose and then the examiner's finger, repeating the movement for 20 seconds. The number of successful repetitions will be recorded.
Unit of Measure: Repetitions in 20 seconds
Measured: Before brace application and 1 hour after brace application
Closed Kinetic Chain Upper Extremity Stability (CKCUES) Test
Participants will perform alternating hand touches between two lines (30 cm apart) while in a modified push-up position. The total number of touches in 15 seconds will be recorded.
Unit of Measure: Number of touches
Measured: Before brace application and 1 hour after brace application
Open Kinetic Chain Upper Extremity Power (Medicine Ball Throw Test)
Upper extremity explosive power will be assessed using the Medicine Ball Throw Test. Participants, kneeling on a mat, will throw a 3-kg medicine ball forward using a chest pass motion. The distance from the starting point to the first contact point will be measured. The best of three trials will be recorded.
Unit of Measure: Centimeters (cm)
Measured: Before brace application and 1 hour after brace application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gözde Yagci (Gür)
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Gözde Yagci (Gür), Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904157
- Sponsor's protocol ID
- HU-KNurdogan-001
- Other IDs
- SBA 23/116
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Shoulder Head Position, Upper Extremity Proprioception, and Upper Extremity Function in Adolescents With Idiopathic Scoliosis Using Braces
- ClinicalTrials.gov ID
- NCT06904157
- Acronym / sponsor ID
- HU-KNurdogan-001
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Scoliosis, Brace, Upper Extremity, Proprioception, Function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gözde Yagci (Gür)University, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional spinal deformity characterized by lateral curvature and vertebral rotation, affecting postural alignment, musculoskeletal function, and neuromuscular control. AIS can lead to asymmetrical loading of the spine and trunk, potentially altering proprioception, postural stability, and functional capacity. Bracing is a widely used conservative treatment aimed at preventing curve progression and maintaining spinal alignment during skeletal growth. However, its effects on upper extremity function, proprioception, and shoulder biomechanics remain underexplored.
Proprioception, the body's ability to sense movement and position, plays a critical role in motor control and stability. In AIS, spinal asymmetry and altered postural alignment may disrupt proprioceptive feedback mechanisms, leading to compensatory movement strategies and potential impairments in upper extremity coordination and function. Additionally, bracing may impose external constraints that influence neuromuscular activation patterns and joint positioning, further affecting movement efficiency and functional performance.
This study aims to investigate the impact of brace use on shoulder position, upper extremity proprioception, and functional performance in adolescents with idiopathic scoliosis. Participants will be assessed in both braced and unbraced conditions to determine how brace-related mechanical constraints influence proprioceptive accuracy, postural adaptation, and functional motor skills. Shoulder position will be analyzed through photographic assessment, while proprioception will be measured using the Laser Pointer-Assisted Angle Reproduction Test. Upper extremity function will be evaluated using standardized clinical assessments, including strength tests, stability and coordination measures, and reaction time assessments.
Understanding the effects of bracing on upper extremity proprioception and function is essential for optimizing rehabilitation strategies in AIS. This study seeks to provide evidence that can inform clinical decision-making regarding brace design, therapy interventions, and functional training approaches to minimize movement restrictions and enhance musculoskeletal performance in adolescents undergoing brace treatment.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (11 listed)
- Inclusion criteria for the patient group;
- 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,
Key exclusion criteria (7 listed)
- Having a diagnosis of Congenital Scoliosis,
- Becoming a Professional Athlete,
- Neuromuscular, Rheumatologic, Renal Except Scoliosis, Any History of Vestibular, Pulmonary or Cardiovascular Disease Finding
- History of Surgical Intervention on the Spine. Exclusion Criteria for Control Group;
- Neuromuscular, Rheumatologic, Renal, Vestibular, Pulmonary Or History of any Cardiovascular Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cobb Angle Measurement
Time frame: Baseline and first week of brace use
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 (°)
Angle of Trunk Rotation (ATR)
Time frame: Before brace application and 1 hour after brace application
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 (°)
Upper Extremity Proprioception Accuracy
Time frame: Before brace application and 1 hour after brace application
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
Anterior Humeral Head Position
Time frame: Before brace application and 1 hour after brace application
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)
6 secondary outcomes
Upper Extremity Muscle Strength
Time frame: Before brace application and 1 hour after brace application
Hand Dexterity (Minnesota Dexterity Test)
Time frame: Before brace application and 1 hour after brace application
Hand Reaction Time (Nelson Hand Reaction Test)
Time frame: Before brace application and 1 hour after brace application
Upper Extremity Coordination (Finger-to-Nose Test)
Time frame: Before brace application and 1 hour after brace application
Closed Kinetic Chain Upper Extremity Stability (CKCUES) Test
Time frame: Before brace application and 1 hour after brace application
Open Kinetic Chain Upper Extremity Power (Medicine Ball Throw Test)
Time frame: Before brace application and 1 hour after brace application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by Gözde Yagci (Gür) at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KÜBRA NURDOĞAN, PT, MSc (+905350699394, kubranurdogan@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb Angle Measurement (time frame: Baseline and first week of brace use). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.