Adolescent Idiopathic ScoliosisNCT03823053
The Effect of the Core Stabilization Training on Respiratory Parameters , Functional Capacity and Balance in Scoliosis
A study testing Home Based Traditional Scoliosis Exercise and Home Based Core Stabilization Training in people with Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic… Read more about this study
- Who is it for?
- Ages 10 to 24 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Home Based Traditional Scoliosis Exercise and Home Based Core Stabilization Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2019to 28 Jun 2019
- 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 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent Idiopathic Scoliosis diagnosis
Who cannot join
- Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessments results.
- Subjects previously undertaken any of spinal surgeries.
- Subjects involved in exercise training 3 or more days a week.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, Eyüp, 34050
About this study
Official title: The Effect of Core Stabilization Training on Respiratory Parameters, Peripheral Muscle Strength, Balance, Functional Capacity and Quality of Life in Children With Adolescent Idiopathic Scoliosis
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.
Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease.Children with adolescent idiopathic scoliosis have inadequate respiratory function and a decrease in functional capacity. At the same time, these children show muscle weakness in certain parts of the body.
The aim of this study was to investigate the relationship between home based core stabilization training, respiratory parameters, peripheral muscle strength, balance, functional capacity and quality of life in individuals with young scoliosis. The investigators suggest that the addition of core stabilization training to children with mild and moderate adolescent idiopathic scoliosis will produce good results.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Home Based Traditional Scoliosis Exercise, Home Based Core Stabilization Training
- Keywords
- Adolescent idiopathic scoliosis, Scoliosis, Core Stabilization Training, Exercise Training, Pulmonary Function Test, 6 - Minute Walk Test, Peripheral Muscle Strength, Balance with Biodex, Quality of Life
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based Traditional Scoliosis ExerciseOther
Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. Exercises will be applied 1 sets of 10 repetitions and once a day.
Home Based Core Stabilization TrainingOther
Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. In addition, the training group received core stabilization exercises for multifidus, transversus abdominis, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and pelvic floor muscles.Exercises will be applied 1 sets of 10 repetitions and once a day.
| 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 30 minutes. The content of the physiotherapy program; posture, interscapular muscle strengthening, stretching and lateral flexion exercises are formed. Receives: Other: Home Based Traditional Scoliosis Exercise |
| Training Group | Experimental | In addition to home based traditional scoliosis exercise, the training group will also receive core stabilization exercise training for 8 weeks, 5 days a week, for 30 minutes. Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and latissimus dorsi. Receives: Other: Home Based Traditional Scoliosis Exercise; Other: Home Based Core Stabilization Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Measured: Eight weeks
Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks
Measured: Eight weeks
Change from baseline Peripheral Muscle strength at 8 weeks
Measured: Eight weeks
Change from baseline Balance at 8 weeks
Measured: Eight weeks
Change from baseline distance covered in Six- Minute Walk Test at 8 weeks
Measured: Eight weeks
Secondary outcomes (1)
Change from baseline axial trunk rotation (ATR)
Measurements will be applied with Bunnell Scoliometer by physiotherapist.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start25 Feb 2019
- Primary completion21 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823053
- Sponsor's protocol ID
- BVUsyildirim01
- Status last verified
- Nov 2020
- First submitted
- 28 Jan 2019
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yildirim S, Ozyilmaz S, Elmadag NM, Yabaci A. Effects of Core Stabilization Exercises on Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength, Functional Capacity, and Perceived Appearance in Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Aug 1;101(8):719-725. doi: 10.1097/PHM.0000000000001984. Epub 2022 Feb 2.
PubMed 35859288
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stabilization Training on Respiratory Parameters, Peripheral Muscle Strength, Balance, Functional Capacity and Quality of Life in Children With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03823053
- Acronym / sponsor ID
- BVUsyildirim01
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Adolescent idiopathic scoliosis, Scoliosis, Core Stabilization Training, Exercise Training, Pulmonary Function Test, 6 - Minute Walk Test, Peripheral Muscle Strength, Balance with Biodex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 30 Jan 2019 (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.
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates.
Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease.Children with adolescent idiopathic scoliosis have inadequate respiratory function and a decrease in functional capacity. At the same time, these children show muscle weakness in certain parts of the body.
The aim of this study was to investigate the relationship between home based core stabilization training, respiratory parameters, peripheral muscle strength, balance, functional capacity and quality of life in individuals with young scoliosis. The investigators suggest that the addition of core stabilization training to children with mild and moderate adolescent idiopathic scoliosis will produce good results.
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 ExerciseThe control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 30 minutes. The content of the physiotherapy program; posture, interscapular muscle strengthening, stretching and lateral flexion exercises are formed. |
| Training Group | Experimental | Other: Home Based Traditional Scoliosis Exercise, Other: Home Based Core Stabilization TrainingIn addition to home based traditional scoliosis exercise, the training group will also receive core stabilization exercise training for 8 weeks, 5 days a week, for 30 minutes. Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and latissimus dorsi. |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent Idiopathic Scoliosis diagnosis
Key exclusion criteria (3 listed)
- Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessments results.
- Subjects previously undertaken any of spinal surgeries.
- Subjects involved in exercise training 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 ExerciseProgram will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. Exercises will be applied 1 sets of 10 repetitions and once a day. | Other | Control Group, Training Group |
| Home Based Core Stabilization TrainingProgram will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. In addition, the training group received core stabilization exercises for multifidus, transversus abdominis, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and pelvic floor muscles.Exercises will be applied 1 sets of 10 repetitions and once a day. | Other | Training Group |
Primary outcome
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time frame: Eight weeks
Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks
Time frame: Eight weeks
Change from baseline Peripheral Muscle strength at 8 weeks
Time frame: Eight weeks
Change from baseline Balance at 8 weeks
Time frame: Eight weeks
Change from baseline distance covered in Six- Minute Walk Test at 8 weeks
Time frame: Eight weeks
1 secondary outcome
Change from baseline axial trunk rotation (ATR)
Time frame: Eight weeks
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 13 Nov 2020.
- Derived from this study: PubMed 35859288Yildirim S, Ozyilmaz S, Elmadag NM, Yabaci A. Effects of Core Stabilization Exercises on Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength, Functional Capacity, and Perceived Appearance in Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Aug 1;101(8):719-725. doi: 10.1097/PHM.0000000000001984. Epub 2022 Feb 2.
- 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.
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 Exercise and Home Based Core Stabilization Training in people with Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif 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 1 inclusion and 3 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 13 Nov 2020. 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?
Change from baseline Forced Vital Capacity (FVC) at 8 weeks (time frame: Eight weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823053, which also lists 1 linked publication.
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 13 Nov 2020.