- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06904157
Investigation of Shoulder Position, Upper Extremity Proprioception, and Function in Adolescents with Idiopathic Scoliosis Using Braces
Investigation of Shoulder Head Position, Upper Extremity Proprioception, and Upper Extremity Function in Adolescents with Idiopathic Scoliosis Using Braces
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: KÜBRA NURDOĞAN, PT, MSc
- Phone Number: +905350699394
- Email: kubranurdogan@hacettepe.edu.tr
Study Contact Backup
- Name: Gözde Yağcı, Prof. Dr.
- Phone Number: +90 507 427 43 51
- Email: gozdeygc8@gmail.com
Study Locations
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Altındağ
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Ankara, Altındağ, Turkey, 06100
- Hacettepe University / Orthotics and Biomechanics Unit
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Contact:
- Fatih Erbahçeci, Prof. Dr.
- Phone Number: +90 312 305 15 76
- Email: ftr@hacettepe.edu.tr
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Contact:
- Gözde YAĞCI, Prof.
- Phone Number: +90 507 427 43 51
- Email: gozdeyg8@gmail.com
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Contact:
- Kübra NURDOĞAN, PT, MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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,
- 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
Exclusion Criteria:
Exclusion Criteria for Patient Group;
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Cobb Angle Measurement
Time Frame: Baseline and first week of brace use
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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
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Angle of Trunk Rotation (ATR)
Time Frame: Before brace application and 1 hour after brace application
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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
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Upper Extremity Proprioception Accuracy
Time Frame: Before brace application and 1 hour after brace application
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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
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Anterior Humeral Head Position
Time Frame: Before brace application and 1 hour after brace application
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Upper Extremity Muscle Strength
Time Frame: Before brace application and 1 hour after brace application
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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) |
Before brace application and 1 hour after brace application
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Hand Dexterity (Minnesota Dexterity Test)
Time Frame: Before brace application and 1 hour after brace application
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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) |
Before brace application and 1 hour after brace application
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Hand Reaction Time (Nelson Hand Reaction Test)
Time Frame: Before brace application and 1 hour after brace application
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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) |
Before brace application and 1 hour after brace application
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Upper Extremity Coordination (Finger-to-Nose Test)
Time Frame: Before brace application and 1 hour after brace application
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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 |
Before brace application and 1 hour after brace application
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Closed Kinetic Chain Upper Extremity Stability (CKCUES) Test
Time Frame: Before brace application and 1 hour after brace application
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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 |
Before brace application and 1 hour after brace application
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Open Kinetic Chain Upper Extremity Power (Medicine Ball Throw Test)
Time Frame: Before brace application and 1 hour after brace application
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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) |
Before brace application and 1 hour after brace application
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-KNurdogan-001
- SBA 23/116 (Other Identifier: Hacettepe University Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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