Adolescent Idiopathic ScoliosisNCT05557773
The Effects of Core Stabilization Exercises on Balance, Proprioception, and Knee Muscle Strength in Children with Adolescent Idiopathic Scoliosis
A study testing Home Based Traditional Scoliosis Exercises and Core Stability Training in people with Adolescent Idiopathic Scoliosis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Scoliosis can be defined as a 3-dimensional deformity in which the lateral deviation and rotation of the vertebrae occur, as well as changes in the physiological curves of the spine. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Home Based Traditional Scoliosis Exercises and Core Stability Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with AIS between the ages of 10-18
- Cobb angle is between 10-40 degrees
- The child's and family's consent to participate in the study
- The child does not receive any other treatment that will affect his scoliosis
Who cannot join
- Surgical operation in the last 3 months
- Presence of an orthopedic, neurological, systemic disease that will prevent him from exercising
- Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises
- Exercising 3 or more days a week.
Trial locations and contacts
1 site in 1 country.
About this study
Scoliosis can be defined as a 3-dimensional deformity in which the lateral deviation and rotation of the vertebrae occur, as well as changes in the physiological curves of the spine. The gold standard criterion is that the Cobb angle, which determines the lateral deviation of the spine in the frontal plane, is greater than 10°.
Postural control and balance occur as a result of the integration of many sensory information. It is thought that postural control and balance in Adolescent Idiopathic Scoliosis (AIS) patients are adversely affected by biomechanical changes in sensory input, central integration, weight transfer mechanism and the structure of the medulla spinalis. In addition to these, vestibular disorders and proprioceptive losses may have an effect on balance.
Read more
Decline in balance reduces the quality of life of individuals with AIS. In addition, exercise has an important place in the treatment of individuals with AIS. In order to get more efficiency from the exercises, it is necessary to improve the balance.
The aim of this study is to evaluate the changes in balance, proprioception, and knee muscle strength of patients, to determine the place of balance exercises in the treatment of individuals with AIS, and to investigate the effect of core stabilization exercises on balance and proprioception in patients with AIS.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Home Based Traditional Scoliosis Exercises, Core Stability Training
- Keywords
- adolescent idiopathic scoliosis, core stabilization exercises, balance, proprioception, knee muscle strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based Traditional Scoliosis ExercisesOther
Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.
Core Stability TrainingOther
Patients in this group will receive traditional scoliosis exercises. In addition, the training group will receive core stabilization exercises for multifidus, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, iliopsoas, gluteus maximus, and pelvic floor muscles.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 45 minutes. Receives: Other: Home Based Traditional Scoliosis Exercises |
| Training Group | Experimental | In addition to conventional home based traditional scoliosis exercises, patients in this group will also receive core stabilization exercise training for 45 minutes, 5 times in a week for 8 weeks. Every two sessions will be supervised in a clinic per week. Receives: Other: Home Based Traditional Scoliosis Exercises; Other: Core Stability Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Evaluation of balance with Biodex Balance System
Measured: 8 week
Proprioception
Evaluation of proprioception with Biodex System 3 Pro Multijoint System
Measured: 8 week
Muscle Strength of Knee Flexion / Extension
Muscle Strength of Knee Measurement of isokinetic muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.e Flexion / Extension
Measured: 8 week
Secondary outcomes (1)
Balance
Evaluation of balance with Modified Romberg test
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Jun 2022
- Primary completion5 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuat Gokdemir, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557773
- Sponsor's protocol ID
- IUFGokdemir02
- Status last verified
- Feb 2023
- First submitted
- 24 Sep 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Core Stabilization Exercises on Balance, Proprioception, and Knee Muscle Strength in Children with Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05557773
- Acronym / sponsor ID
- IUFGokdemir02
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- adolescent idiopathic scoliosis, core stabilization exercises, balance, proprioception, knee muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 5 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 28 Sep 2022 (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.
Scoliosis can be defined as a 3-dimensional deformity in which the lateral deviation and rotation of the vertebrae occur, as well as changes in the physiological curves of the spine. The gold standard criterion is that the Cobb angle, which determines the lateral deviation of the spine in the frontal plane, is greater than 10°.
Postural control and balance occur as a result of the integration of many sensory information. It is thought that postural control and balance in Adolescent Idiopathic Scoliosis (AIS) patients are adversely affected by biomechanical changes in sensory input, central integration, weight transfer mechanism and the structure of the medulla spinalis. In addition to these, vestibular disorders and proprioceptive losses may have an effect on balance.
Decline in balance reduces the quality of life of individuals with AIS. In addition, exercise has an important place in the treatment of individuals with AIS. In order to get more efficiency from the exercises, it is necessary to improve the balance.
The aim of this study is to evaluate the changes in balance, proprioception, and knee muscle strength of patients, to determine the place of balance exercises in the treatment of individuals with AIS, and to investigate the effect of core stabilization exercises on balance and proprioception in patients with AIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Home Based Traditional Scoliosis ExercisesThe control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 45 minutes. |
| Training Group | Experimental | Other: Home Based Traditional Scoliosis Exercises, Other: Core Stability TrainingIn addition to conventional home based traditional scoliosis exercises, patients in this group will also receive core stabilization exercise training for 45 minutes, 5 times in a week for 8 weeks. Every two sessions will be supervised in a clinic per week. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with AIS between the ages of 10-18
- Cobb angle is between 10-40 degrees
- The child's and family's consent to participate in the study
- The child does not receive any other treatment that will affect his scoliosis
Key exclusion criteria (4 listed)
- Surgical operation in the last 3 months
- Presence of an orthopedic, neurological, systemic disease that will prevent him from exercising
- Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises
- Exercising 3 or more days a week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Based Traditional Scoliosis ExercisesPatients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises. | Other | Control Group, Training Group |
| Core Stability TrainingPatients in this group will receive traditional scoliosis exercises. In addition, the training group will receive core stabilization exercises for multifidus, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, iliopsoas, gluteus maximus, and pelvic floor muscles. | Other | Training Group |
Primary outcome
Balance
Time frame: 8 week
Evaluation of balance with Biodex Balance System
Proprioception
Time frame: 8 week
Evaluation of proprioception with Biodex System 3 Pro Multijoint System
Muscle Strength of Knee Flexion / Extension
Time frame: 8 week
Muscle Strength of Knee Measurement of isokinetic muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.e Flexion / Extension
1 secondary outcome
Balance
Time frame: 8 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Traditional Scoliosis Exercises and Core Stability Training in people with Adolescent Idiopathic Scoliosis, run by Istanbul University 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 8 week). The study lists 3 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 10 Feb 2025.