ScoliosisNCT05377086
Structured 3D Exercise and the Conventional Exercise Program for Scoliosis in Children With Rheumatic Disease
A study testing Schroth 3-Dimensional scoliosis exercise and conventional scoliosis exercise in people with Scoliosis and Juvenile Idiopathic Arthritis, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Usage including cases followed up with rheumatism diagnosis and treatment in Istanbul University-Cerrahpasa Medical Faculty Pediatric Rheumatology Clinic, Physiotherapy and Rehabilitation Unit. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis, Juvenile Idiopathic Arthritis
- What is being tested?
- Schroth 3-Dimensional scoliosis exercise and conventional scoliosis exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2022to 1 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cases with a diagnosis of rheumatism in whom scoliosis problems were detected by spine X-ray,
- be between the ages of 8-16,
- Being between 0-4 in the riser,
- Being in exercise indication (Cobb=10-45 ˚)
Who cannot join
- Having an additional neurological or orthopedic diagnosis other than scoliosis accompanying rheumatism and affecting treatment results
- Having had any surgery on the spine
- Have had previous scoliosis treatment poor mental state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of the Structured 3D Exercise and the Conventional Exercise Program for Scoliosis in Children With Rheumatic Disease
Usage including cases followed up with rheumatism diagnosis and treatment in Istanbul University-Cerrahpasa Medical Faculty Pediatric Rheumatology Clinic, Physiotherapy and Rehabilitation Unit. The study included 50 patients with a spinal x-ray scoliosis problem, aged 8-16 years, who were diagnosed with rheumatism at least 6 months ago, whose medical treatment was stable, Risser 0-4 and exercise indication (Cobb = 10-45ͦ). Patients with additional neurological diagnosis against rheumatism, who have received any previous treatment for a spine problem, who have a mental state and who do not have the consent of their family will not be included. The cases will be divided into 2 groups by method. In the first group (n = 25), structured 3-dimensional scoliosis exercises are taught in the clinic, and the second group (n = 25) is taught conventional physiotherapy applications (posture-core applications-bennet protocols) in the clinic, and both groups are followed by the WTE method.
Read the detailed description
The demographic and clinical characteristics of all subjects willing to participate in the study will be questioned with the "Sociodemographic Data Form". Sociodemographic data form; pain, age, gender, height, weight, type of rheumatism, how many years ago the patient was diagnosed, the presence of rheumatism and scoliosis in the family, the drugs used, exercise habits, exacerbation history, whether they used a device before, and the awareness of the family about scoliosis. The trunk rotation angles with the forward bend test and the Cobb angle with the SubrotoAngleAid application via x-ray. Respiratory functions will be evaluated with portable spirometer, body awareness will be evaluated with Walter Reed Visual Assessment Scale, and quality of life will be evaluated with Scoliosis Research Association Scale-22 (SRS-22). After the evaluations, in the first treatment session in the clinic, the cases in the first group; Body awareness, respiratory control, differences between rotational and normal breathing, posture exercises and core stabilization exercises will be taught and family training will be provided. In the next session, a home program will be created by applying 3D scoliosis exercises that are structured according to the needs of the patients. Body awareness, respiratory control, posture exercises and core stabilization exercises will be taught and family training will be given to the patients in the second group in the first treatment session. In the next session, conventional exercises for the needs of the cases will be taught and a home exercise program will be created. Both groups will be interviewed for 2-week periods using the WTE method, and the exercises will be progressed gradually as needed. At the beginning of the treatment and in the 6th month, all evaluations will be repeated and the effectiveness of the exercises will be investigated. SPSS (Statistical Package for Social Sciences) (SPSS 21.0) statistical program will be used in the statistical analysis of the data. In all statistical analyzes, p <0.05 will be considered significant.
- Conditions
- Scoliosis, Juvenile Idiopathic Arthritis
- Being tested
- Schroth 3-Dimensional scoliosis exercise, conventional scoliosis exercise
- Keywords
- scoliosis, Juvenile idiopathic arthritis, 3D exercise
- Medical subject headings
- Scoliosis, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schroth 3-Dimensional scoliosis exerciseOther
Schroth 3-Dimensional scoliosis exercises
conventional scoliosis exerciseOther
conventional scoliosis exercise
| Study group | Role | What they receive |
|---|---|---|
| schroth group | Experimental | This arm was planned as the exercise group which includes Schroth 3-Dimensional scoliosis exercise. Receives: Other: Schroth 3-Dimensional scoliosis exercise |
| conventional group | Experimental | This arm was planned as the exercise group which includes conventional scoliosis exercise. Receives: Other: conventional scoliosis exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angle
Measuring the scoliosis angle on x-ray is the most commonly used method. The Cobb angle is most commonly used to measure the magnitude of the curve. Measurements are made on a standing posteroanterior spine radiograph as standard. To determine the boundaries of the scoliosis, a line is drawn parallel to the upper line of the vertebra with the greatest deviation. Similarly, for the lower border, a line is drawn parallel to the lowest vertebra. Vertical lines are drawn parallel to these two lines and the angle between the two lines is measured. This angle is defined as the scoliosis angle (Cobb angle). Radiological imaging will only be applied to children who are considered to be in need by the doctor as a result of physical examination. The measurement of the Cobb angle will be made on the X-ray via the SubrotoAngleAid application.
Measured: 0-6 month
Trunk rotation with Scoliometer
The trunk rotation angle will be measured with a scoliometer. It is an easy to use, reliable, practical and specially designed inclinometer in the clinical evaluation of scoliosis. It is accepted as a clinical evaluation method used in addition to radiological methods in determining the efficacy of treatment and the prognosis of scoliosis.
Measured: 0-6 month
Secondary outcomes (5)
Physical deformity assesment using with The Walter Reed Visual Assessment Scale (WRVAS)
The Walter Reed Visual Assessment Scale (WRVAS) developed to evaluate the physical deformity perceived by patients with idiopathic scoliosis. Walter Reed Visual Evaluation Scale evaluates deformity from 7 aspects; spine curvature, rib protrusion, lumbar protrusion, thorax deformity relative to pelvis (alignment disorder), trunk imbalance, shoulder and scapula asymmetry. For each of the 7 questions that make up the Walter Reed visual assessment scale, there is an answer section consisting of 5 different pictures indicating different degrees of deformity. Each deformity is scored with these pictures as a minimum of "1" and a maximum of "5". The scale will be filled in by the therapist.
Measured: 0-6 month
FEV1
It is a physiological test in which the volume of air an individual inhales or exhales is evaluated as a function of time. Pulmonary function test will be done with a portable spirometer (Contec SP10W). Forced expiration test; calm breathing followed by a forced inspiration followed by an expiration as fast and deep (forced) as possible. During the test, the patient will be placed in a sitting position in a way that is comfortable and the patient will be prevented from breathing in and out of the nose with the nose clip. Maneuvers that may affect the test results such as bending forward and neck flexion during forced expiration will be prevented. Expiration should continue for at least six seconds and eventually plateau. Care will be taken to ensure that there is no leakage in the system.
Measured: 0-6 month
FVC
It is a physiological test in which the volume of air an individual inhales or exhales is evaluated as a function of time. Pulmonary function test will be done with a portable spirometer (Contec SP10W). Forced expiration test; calm breathing followed by a forced inspiration followed by an expiration as fast and deep (forced) as possible. During the test, the patient will be placed in a sitting position in a way that is comfortable and the patient will be prevented from breathing in and out of the nose with the nose clip. Maneuvers that may affect the test results such as bending forward and neck flexion during forced expiration will be prevented. Expiration should continue for at least six seconds and eventually plateau. Care will be taken to ensure that there is no leakage in the system.
Measured: 0-6 month
PEF
It is a physiological test in which the volume of air an individual inhales or exhales is evaluated as a function of time. Pulmonary function test will be done with a portable spirometer (Contec SP10W). Forced expiration test; calm breathing followed by a forced inspiration followed by an expiration as fast and deep (forced) as possible. During the test, the patient will be placed in a sitting position in a way that is comfortable and the patient will be prevented from breathing in and out of the nose with the nose clip. Maneuvers that may affect the test results such as bending forward and neck flexion during forced expiration will be prevented. Expiration should continue for at least six seconds and eventually plateau. Care will be taken to ensure that there is no leakage in the system.
Measured: 0-6 month
QUALITY OF LIFE ASSESSMENT
Scoliosis Research Society Scale-22 (SRS-22)" questionnaire is an inquiry form designed for scoliosis and evaluating quality of life. It consists of 23 questions with five subgroups. These subgroups are; pain, image/appearance, function/activity, mental health, and treatment satisfaction. It is defined as 0 (worst) and 5 (best) points for each question. Patients will be asked to mark the answers that are suitable for them and the form will be filled. (because of pandemic, its not completed)
Measured: 0-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start17 May 2022
- Primary completion15 Dec 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylül Pınar KISA, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377086
- Sponsor's protocol ID
- PHD Thesis
- Status last verified
- Jun 2023
- First submitted
- 1 May 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of the Structured 3D Exercise and the Conventional Exercise Program for Scoliosis in Children With Rheumatic Disease
- ClinicalTrials.gov ID
- NCT05377086
- Acronym / sponsor ID
- PHD Thesis
- Conditions
- Scoliosis, Juvenile Idiopathic Arthritis
- Keywords
- scoliosis, Juvenile idiopathic arthritis, 3D exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 17 May 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.
Usage including cases followed up with rheumatism diagnosis and treatment in Istanbul University-Cerrahpasa Medical Faculty Pediatric Rheumatology Clinic, Physiotherapy and Rehabilitation Unit. The study included 50 patients with a spinal x-ray scoliosis problem, aged 8-16 years, who were diagnosed with rheumatism at least 6 months ago, whose medical treatment was stable, Risser 0-4 and exercise indication (Cobb = 10-45ͦ). Patients with additional neurological diagnosis against rheumatism, who have received any previous treatment for a spine problem, who have a mental state and who do not have the consent of their family will not be included. The cases will be divided into 2 groups by method. In the first group (n = 25), structured 3-dimensional scoliosis exercises are taught in the clinic, and the second group (n = 25) is taught conventional physiotherapy applications (posture-core applications-bennet protocols) in the clinic, and both groups are followed by the WTE method.
Detailed description
The demographic and clinical characteristics of all subjects willing to participate in the study will be questioned with the "Sociodemographic Data Form". Sociodemographic data form; pain, age, gender, height, weight, type of rheumatism, how many years ago the patient was diagnosed, the presence of rheumatism and scoliosis in the family, the drugs used, exercise habits, exacerbation history, whether they used a device before, and the awareness of the family about scoliosis. The trunk rotation angles with the forward bend test and the Cobb angle with the SubrotoAngleAid application via x-ray. Respiratory functions will be evaluated with portable spirometer, body awareness will be evaluated with Walter Reed Visual Assessment Scale, and quality of life will be evaluated with Scoliosis Research Association Scale-22 (SRS-22). After the evaluations, in the first treatment session in the clinic, the cases in the first group; Body awareness, respiratory control, differences between rotational and normal breathing, posture exercises and core stabilization exercises will be taught and family training will be provided. In the next session, a home program will be created by applying 3D scoliosis exercises that are structured according to the needs of the patients. Body awareness, respiratory control, posture exercises and core stabilization exercises will be taught and family training will be given to the patients in the second group in the first treatment session. In the next session, conventional exercises for the needs of the cases will be taught and a home exercise program will be created. Both groups will be interviewed for 2-week periods using the WTE method, and the exercises will be progressed gradually as needed. At the beginning of the treatment and in the 6th month, all evaluations will be repeated and the effectiveness of the exercises will be investigated. SPSS (Statistical Package for Social Sciences) (SPSS 21.0) statistical program will be used in the statistical analysis of the data. In all statistical analyzes, p <0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schroth group | Experimental | Other: Schroth 3-Dimensional scoliosis exerciseThis arm was planned as the exercise group which includes Schroth 3-Dimensional scoliosis exercise. |
| conventional group | Experimental | Other: conventional scoliosis exerciseThis arm was planned as the exercise group which includes conventional scoliosis exercise. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Cases with a diagnosis of rheumatism in whom scoliosis problems were detected by spine X-ray,
- be between the ages of 8-16,
- Being between 0-4 in the riser,
- Being in exercise indication (Cobb=10-45 ˚)
Key exclusion criteria (3 listed)
- Having an additional neurological or orthopedic diagnosis other than scoliosis accompanying rheumatism and affecting treatment results
- Having had any surgery on the spine
- Have had previous scoliosis treatment poor mental state
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 |
|---|---|---|
| Schroth 3-Dimensional scoliosis exerciseSchroth 3-Dimensional scoliosis exercises | Other | schroth group |
| conventional scoliosis exerciseconventional scoliosis exercise | Other | conventional group |
Primary outcome
Cobb angle
Time frame: 0-6 month
Measuring the scoliosis angle on x-ray is the most commonly used method. The Cobb angle is most commonly used to measure the magnitude of the curve. Measurements are made on a standing posteroanterior spine radiograph as standard. To determine the boundaries of the scoliosis, a line is drawn parallel to the upper line of the vertebra with the greatest deviation. Similarly, for the lower border, a line is drawn parallel to the lowest vertebra. Vertical lines are drawn parallel to these two lines and the angle between the two lines is measured. This angle is defined as the scoliosis angle (Cobb angle). Radiological imaging will only be applied to children who are considered to be in need by the doctor as a result of physical examination. The measurement of the Cobb angle will be made on the X-ray via the SubrotoAngleAid application.
Trunk rotation with Scoliometer
Time frame: 0-6 month
The trunk rotation angle will be measured with a scoliometer. It is an easy to use, reliable, practical and specially designed inclinometer in the clinical evaluation of scoliosis. It is accepted as a clinical evaluation method used in addition to radiological methods in determining the efficacy of treatment and the prognosis of scoliosis.
5 secondary outcomes
Physical deformity assesment using with The Walter Reed Visual Assessment Scale (WRVAS)
Time frame: 0-6 month
FEV1
Time frame: 0-6 month
FVC
Time frame: 0-6 month
PEF
Time frame: 0-6 month
QUALITY OF LIFE ASSESSMENT
Time frame: 0-6 month
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 15 Jun 2023.
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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 Schroth 3-Dimensional scoliosis exercise and conventional scoliosis exercise in people with Scoliosis and Juvenile Idiopathic Arthritis, run by Biruni 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 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 15 Jun 2023. 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?
Cobb angle (time frame: 0-6 month). The study lists 2 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 15 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.