Scoliosis; AdolescenceNCT06224361
Reliability of a New Balance Assessment System in Patients With Adolescent Idiopathic Scoliosis
An observational study of Scoliosis; Adolescence, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Postural stability is one of the most important factors determining a person's ability to initiate and maintain movement. In the presence of scoliosis, postural stability may be negatively affected due to somatosensory impairments. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Scoliosis; Adolescence
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Feb 2024to 30 Dec 2025
- Phase
- Observational
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents diagnosed with adolescent idiopathic scoliosis between the ages of 12-18 who meet the inclusion criteria will be included in our study.
Who may be able to join
- Being between the ages of 12 and 18
- Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist
- Cobb angle measured on anteroposterior radiograph is below 40 degrees
- Ability to understand and follow instructions
- Volunteering to participate in the study
Who cannot join
- Presence of neuromuscular, rheumatic disease, or vestibular problems that may affect balance, vision-related diseases
- Having a recent history of orthopedic injury or surgery in the lower extremity
- Having had spine surgery
- Not having experienced any acute situation that could affect postural stability and balance between the two tests (within 7 days)
- Corset use has not changed between two tests (within 7 days)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Empatim Özel Eğitim ve Rehabilitasyon Merkezi
Istanbul
About this study
Postural stability is one of the most important factors determining a person's ability to initiate and maintain movement. In the presence of scoliosis, postural stability may be negatively affected due to somatosensory impairments. Numerous studies in the literature have evaluated postural stability in individuals diagnosed with scoliosis using objective methods.
The evaluation of postural sway with objective devices is used to determine whether postural stability changes in adolescent idiopathic scoliosis (AIS) and whether the type and location of scoliosis affect progression. The most commonly used objective devices for this purpose are balance assessment systems in which changes in postural sway are recorded on a force platform.
Read more
This study aims to investigate the reliability of the Postural Stability, Limits of Stability, Sensory Integration, and Bilateral Comparison tests of the Al Balance Balance Exercise and Analysis System in individuals with adolescent idiopathic scoliosis.
After the demographic information of participants who meet the inclusion criteria is recorded, postural stability and balance evaluations will be performed using the Al Balance System. Evaluations will be carried out with participants barefoot and with their feet positioned at the same coordinates.
Each test will last 30 seconds and will be repeated three times, with a 1-minute rest interval between trials. These measurements will be repeated after 7 days to evaluate reliability.
This study will test the reliability of a new, locally developed balance assessment system in individuals with adolescent idiopathic scoliosis.
- Conditions
- Scoliosis; Adolescence
- Keywords
- scoliosis, postural control, balance, reliability
- 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 |
|---|---|---|
| Reliability | Participants will be evaluated with the "Postural Stability Test", "Limits of Stability Test", "Sensory Integration Test" and "Bilateral Comparison Test" within the AlBalance Balance Evaluation System. To calculate the test-retest reliability of the device, these measurements will be made by the same evaluator, will last 30 seconds and will be repeated a total of 3 times with a 1-minute rest between tests. These measurements will be repeated after 7 days to evaluate reliability. Then, parallel clinical tests will be applied to the participants, "Functional Reaching Test" and "One Leg Standing Test". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability Test
Stability indices represent fluctuations around the zero point established before testing when the platform is stable. With the "Postural Stability Test", the anteroposterior, right-left, and general stability indexes of the cases will be recorded. During the test, participants will be asked to stand on the force platform with their feet in a comfortable position, arms at their sides, and palms facing toward the thighs. All measurements will be made with bare feet, and without shoes, and foot position will be recorded using coordinates on the platform's grid to ensure consistency in testing. The participant will be asked to stand still looking at the screen in front of him for 30 seconds. There will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's Postural Stability will be assessed with Postural Stability Test.
Measured: Change from baseline to 7 day
Limits of Stability
In this test, the participant stands on force plates and deliberately shifts his or her body weight in the direction indicated on the screen without lifting his or her feet off the ground. This protocol measures various movement characteristics in 8 different directions: front, forward/right, right, back/right, back, back/left, left, and forward/left. During the test, participants will be asked to stand on the force platform with their feet in a comfortable position, arms at their sides, and palms facing toward the thighs. Direction control (%) and test times (sec) in all directions of the participants, who will move in 8 different directions sequentially, will be recorded. There will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's Limits of Stability will be assessed with Limits of Stability Test.
Measured: Change from baseline to 7 day
Sensory Integration Test
The test decides which of the visual, vestibular, and proprioceptive information is used to provide orientation to maintain balance in different situations. During the test, visual and proprioceptive stimuli are disrupted and the ability to maintain the center of gravity is evaluated. The test consists of 4 different situations that gradually become more difficult: Situation 1: Eyes open; firm surface Situation 2: Eyes closed; firm surface Situation 3: Eyes open; foam surface Situation 4: Eyes closed; foam surface All measurements will be made with bare feet, and without shoes, and foot position will be recorded using coordinates on the platform's grid to ensure consistency in testing. The participant will be asked to stand still looking at the screen in front of him for 30 seconds. There will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's Sensory Integration will be assessed with Sensory Integration Test.
Measured: Change from baseline to 7 day
Bilateral Comparison Test
Bilateral Comparison test demonstrates postural stability by measuring the individual's ability to stand on one leg with eyes open and closed. On the balance platform, the individual stands on one leg with his hands at hip level. The test is repeated for the right foot and left foot. For both feet, 3 trials with eyes open and 3 trials with eyes closed are made. Each trial lasts 30 seconds. What is required from the individual is to remain stable on one leg as much as possible without losing balance. All measurements will be made with bare feet, and without shoes, and foot position will be recorded using coordinates on the platform's grid to ensure consistency in testing. The participant's Bilateral Comparison will be assessed with Bilateral Comparison Test.
Measured: Change from baseline to 7 day
Multimodal Functional Reach Test
Multimodal functional reaching test is performed in three different positions: front, back, and side.
In the functional forward reach test, the patient stands with the arm flexed at 90° and the fist closed, not touching but close to the wall. Three attempts are made and the average of these attempts is taken.
In the functional back reach test, the patient stands with the arm flexed at 90° and the fist closed, not touching but close to the wall. Three attempts are made and the average of these attempts is taken.
In the functional lateral reach test, the patient stands with his back to the wall, without touching the wall, keeping his arm in 90° abduction and his fist closed. Three attempts are made and the average of these attempts is taken. The participant's Multimodal Functional Reach balance will be assessed with Multimodal Functional Reach Test.
Measured: Change from baseline to 7 day
One Leg Stance Test
The one-leg stance test demonstrates postural stability by measuring the individual's ability to stand on one leg with eyes open and closed. The individual stands on one leg with his hands at hip level. The test is repeated for the right foot and left foot. For both feet, 3 trials with eyes open and 3 trials with eyes closed are made. Each trial lasts 30 seconds. What is required from the individual is to remain stable on one leg as much as possible without losing balance. The participant's One Leg Stance balance will be assessed with One Leg Stance Test.
Measured: Change from baseline to 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start29 Feb 2024
- Primary completion30 Jun 2024
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis; AdolescenceStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elcin Akyurek, Istanbul University - Cerrahpasa
- Investigators
- Asena Yekdaneh, Principal investigator, Fenerbahçe Universityİrem Kurt Ulusoy, Principal investigator, Istanbul University-Cerrahpasa, Institute of Postgraduate EducationNilay Arman, Principal investigator, Istanbul University-Cerrahpasa Faculty of Health ScienceAyşe Zengin Alpözgen, Principal investigator, Istanbul University-Cerrahpaşa Faculty of Health SciencesElçin Akyürek, Study chair, Istanbul University-Cerrahpasa, Institute of Postgraduate Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224361
- Sponsor's protocol ID
- AkyurekE2
- Status last verified
- May 2026
- First submitted
- 16 Jan 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No