Adolescent Idiopathic ScoliosisNCT05056363
The Effects of Core Stability Training 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
Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine in which lateral flexion and axial rotation are seen in vertebrae with a Cobb (method for measuring spinal curvature) angle of 10° and above. Read more about this study
- Who is it for?
- Ages 10 to 20 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
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2021to 25 Mar 2022
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with AIS between the ages of 10-20
- Cobb angle is between 15-40 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
Official title: In The Light of Isokinetic Test and sEMG: How Effective Is Core Stability Exercise Training On Cobb Angle Muscle Strenght and Quality of Life In Adolescent Idiopathic Scoliosis
Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine in which lateral flexion and axial rotation are seen in vertebrae with a Cobb (method for measuring spinal curvature) angle of 10° and above. AIS is the most common type of scoliosis and it occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.
Children with AIS have cosmetic effects, decrease in functional capacity, muscle weakness in certain parts of the body, decrease in quality of life and posture disorders. Lack of core stability might be causing these problems.
Read more
Core stability training may have a positive effect for these problems experienced by children with AIS.
Pathologies that cause the disease may originate from the nervous system and musculoskeletal system. In this study, the investigators will evaluate these systems objectively with EMG biofeedback and Isokinetic Testing.
The aim of this study is to show the effect of core stability training on various problems (as we mentioned before) caused by the disease. In addition, the investigators of this study hope to contribute to the literature(with objective evaluations) about the pathological background and treatment of this challenging disease which the cause is unknown.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Home Based Traditional Scoliosis Exercises, Core Stability Training
- Keywords
- Isokinetic Testing, EMG Biofeedback, Core Stability
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.
Muscle Strength of Trunk Flexion / Extension
Measurement of isokinetic and isometric muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.
Measured: 8 week
Cobb Angle
Cobb Angle measurement with AP Radiography
Measured: 8 week
Muscle Strength
Evaluation of the muscle strength with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
Measured: 8 week
Muscle Electromyographic Activity
Measurement of the surface electromyographic activity with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
Measured: 8 week
Secondary outcomes (4)
Trunk Rotation
Evaluation of the thoracic, thoracic-lumber junction, lumber axial trunk rotation with Bunnell Scoliometer
Measured: 8 week
Patients Quality of Life
Quality of life will be measured with using the Scoliosis Research Society 22 item questionnaire (SRS-22r).
SRS-22 has a minimum score of 22 and a maximum score of 110. Each question is scored on 1-5 scale. Questions are sorted into different domains and total and mean scores for each domain are calculated. A total score for the entire questionnaire is also calculated.
Measured: 8 week
Cosmetic Deformity Evaluation
Patients cosmetic deformity will be evaluated with Walter Reed Visuel Assesment Scale.
This scale includes seven items with figures representing different aspects of the spinal deformity: spinal deformity, rib prominence, lumbar prominence, thoracic deformity, trunk imbalance, shoulder asymmetry and scapular asymmetry. The figures are scored from minimum (1, no deformity) to maximum (5, severe deformity) and summed up to yield a total score (minimum: 5 points, maximum: 35 points).
Measured: 8 week
Flexibility Measurement
Patients flexibility will be measured with forward and lateral bending tests
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 posted24 Sep 2021
- Study start5 Oct 2021
- Primary completion10 Mar 2022
- Study completion25 Mar 2022
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuat Gokdemir, Istanbul University
- Investigators
- Fuat Gökdemir, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056363
- Sponsor's protocol ID
- IUFGokdemir01
- Status last verified
- Feb 2024
- First submitted
- 15 Sep 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In The Light of Isokinetic Test and sEMG: How Effective Is Core Stability Exercise Training On Cobb Angle Muscle Strenght and Quality of Life In Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05056363
- Acronym / sponsor ID
- IUFGokdemir01
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Isokinetic Testing, EMG Biofeedback, Core Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 24 Sep 2021 (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.
Adolescent idiopathic scoliosis (AIS) is a three-dimensional structural deformity of the spine in which lateral flexion and axial rotation are seen in vertebrae with a Cobb (method for measuring spinal curvature) angle of 10° and above. AIS is the most common type of scoliosis and it occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.
Children with AIS have cosmetic effects, decrease in functional capacity, muscle weakness in certain parts of the body, decrease in quality of life and posture disorders. Lack of core stability might be causing these problems.
Core stability training may have a positive effect for these problems experienced by children with AIS.
Pathologies that cause the disease may originate from the nervous system and musculoskeletal system. In this study, the investigators will evaluate these systems objectively with EMG biofeedback and Isokinetic Testing.
The aim of this study is to show the effect of core stability training on various problems (as we mentioned before) caused by the disease. In addition, the investigators of this study hope to contribute to the literature(with objective evaluations) about the pathological background and treatment of this challenging disease which the cause is unknown.
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 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with AIS between the ages of 10-20
- Cobb angle is between 15-40 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
Muscle Strength of Trunk Flexion / Extension
Time frame: 8 week
Measurement of isokinetic and isometric muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.
Cobb Angle
Time frame: 8 week
Cobb Angle measurement with AP Radiography
Muscle Strength
Time frame: 8 week
Evaluation of the muscle strength with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
Muscle Electromyographic Activity
Time frame: 8 week
Measurement of the surface electromyographic activity with using a non-invasive Myomed 932 EMG-biofeedback device (Enraf-Nonius, The Netherlands)
4 secondary outcomes
Trunk Rotation
Time frame: 8 week
Patients Quality of Life
Time frame: 8 week
Cosmetic Deformity Evaluation
Time frame: 8 week
Flexibility Measurement
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 21 Feb 2024.
- 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. This study is not recruiting at the moment.
Fuat Gökdemir principal investigator
Istanbul University
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 21 Feb 2024. 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?
Muscle Strength of Trunk Flexion / Extension (time frame: 8 week). 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 21 Feb 2024.