Scoliosis IdiopathicNCT04203394
Comparison of the Effects of Controlled Schroth Exercise and Home Exercise Programs
A study testing Schroth Exercise Group and Home Exercise Group in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of Schroth 3D exercise method on home symmetry, trunk topography, scapula symmetry, pelvic symmetry, health related quality of life and cosmetic deformity perception in adolescents with idiopathic scoliosis Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis; Adolescence
- What is being tested?
- Schroth Exercise Group and Home Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2019to 30 May 2021
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with scoliosis diagnosed and followed up by the attending physician
- 10-16 age group,
- Patients who voluntarily agreed to participate in the study
- Living in Antalya/TURKEY
Who cannot join
- Mental retardation, congenital scoliosis or spinal deformity, spinal surgery, neuromuscular disease, rheumatologic disease, tumor, cardiovascular or pulmonary disease, vertigo attack or balance problem, neurological disease
- İndividual who does not sign the consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Physical Therapy and Rehabilitation
Antalya, Konyaalti, 07100
About this study
Official title: Comparison of the Effects of Controlled Schroth Exercise and Home Programs on Body Symmetry, Deformity Perception and Quality of Life in Adolescent Idiopathic Scoliosis
The aim of this study is to compare the effects of Schroth 3D exercise method on home symmetry, trunk topography, scapula symmetry, pelvic symmetry, health related quality of life and cosmetic deformity perception in adolescents with idiopathic scoliosis
Read the detailed description
Cobb angle measurement, which is accepted as the gold standard in patients with scoliosis, is a radiological measurement. However, in continuous follow-up, the search for other methods to obtain objective data that will provide a short term evaluation on the patient in determining the efficacy of conservative treatment continues.
In our study, individuals who meet the criteria will be evaluated at the beginning and end of the study. Sociodemographic features and scoliosis characteristics (Cobb angle, degree of bone maturation according to Risser, apex, vertebra rotation angle) will be recorded. Posterior Trunk Asymmetry Index (POTSI) will be used to determine body asymmetry, and topographic measurements will be performed with Artec Eva 3D Scanner and motion analysis will be performed with Biomechanical Motion Analysis Sistem (Model is BTS Smart DX100) . Individuals will evaluate their cosmetic deformities with the Walter Reed Visual Evaluation Scale. Scoliosis Research Society-22 will be used to measure quality of life.
- Conditions
- Scoliosis Idiopathic, Scoliosis; Adolescence
- Being tested
- Schroth Exercise Group, Home Exercise Group
- Keywords
- Schroth exercise, conservative treatment, scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schroth Exercise GroupOther
12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise
Home Exercise GroupOther
Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise
| Study group | Role | What they receive |
|---|---|---|
| Schroth Exercise Group | Experimental | 12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise Receives: Other: Schroth Exercise Group |
| Home Exercise Group | Experimental | Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise Receives: Other: Home Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Mean Square(RMS)
Body right and left asymmetry will be examined.
Measured: 12 weeks
3D Motion analysis
3D motion analysis with 4 cameras, symmetry of certain points will be evaluated during motion.
Measured: 12 weeks
Postural Trunk Asymmetry Index (POTSI)
It is a method that allows an individual with AIS to evaluate body shape and asymmetry.
Measured: 12 weeks
Walter Reed Visuel Assesment Scale
Walter Reed Visuel Assesment Scale (WRVAS) each aspect is shown with five levels of increasing severity of the seven type of deformity that are scored from minimum (1) to maximum (5). How individuals perceive their own cosmetic deformities and the effectiveness of treatment in improving cosmetic deformity can be evaluated
Measured: 12 weeks
Scoliosis Research Society-22
Scoliosis Research Society (SRS-22) is a simple and practical questionnaire specific to individuals with scoliosis. The questionnaire included pain, self-image, function / activity, mental health and treatment satisfaction. There are 22 questionnaire questions, scoring from 1 to 5. The minimum score is the worst score (22).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start18 Aug 2019
- Primary completion30 Jan 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Sponsor
- Investigators
- KADRIYE TOMBAK, Study director, AKDENIZ UNIVERSITY PHYSICAL THERAPY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203394
- Sponsor's protocol ID
- 02.04.2018 2018/57-06
- Status last verified
- Oct 2022
- First submitted
- 16 Dec 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Controlled Schroth Exercise and Home Programs on Body Symmetry, Deformity Perception and Quality of Life in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT04203394
- Acronym / sponsor ID
- 02.04.2018 2018/57-06
- Conditions
- Scoliosis Idiopathic, Scoliosis; Adolescence
- Keywords
- Schroth exercise, conservative treatment, scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 18 Aug 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 18 Dec 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 aim of this study is to compare the effects of Schroth 3D exercise method on home symmetry, trunk topography, scapula symmetry, pelvic symmetry, health related quality of life and cosmetic deformity perception in adolescents with idiopathic scoliosis
Detailed description
Cobb angle measurement, which is accepted as the gold standard in patients with scoliosis, is a radiological measurement. However, in continuous follow-up, the search for other methods to obtain objective data that will provide a short term evaluation on the patient in determining the efficacy of conservative treatment continues.
In our study, individuals who meet the criteria will be evaluated at the beginning and end of the study. Sociodemographic features and scoliosis characteristics (Cobb angle, degree of bone maturation according to Risser, apex, vertebra rotation angle) will be recorded. Posterior Trunk Asymmetry Index (POTSI) will be used to determine body asymmetry, and topographic measurements will be performed with Artec Eva 3D Scanner and motion analysis will be performed with Biomechanical Motion Analysis Sistem (Model is BTS Smart DX100) . Individuals will evaluate their cosmetic deformities with the Walter Reed Visual Evaluation Scale. Scoliosis Research Society-22 will be used to measure quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schroth Exercise Group | Experimental | Other: Schroth Exercise Group12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise |
| Home Exercise Group | Experimental | Other: Home Exercise GroupHome exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with scoliosis diagnosed and followed up by the attending physician
- 10-16 age group,
- Patients who voluntarily agreed to participate in the study
- Living in Antalya/TURKEY
Key exclusion criteria (2 listed)
- Mental retardation, congenital scoliosis or spinal deformity, spinal surgery, neuromuscular disease, rheumatologic disease, tumor, cardiovascular or pulmonary disease, vertigo attack or balance problem, neurological disease
- İndividual who does not sign the consent form
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 Exercise Group12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise | Other | Schroth Exercise Group |
| Home Exercise GroupHome exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise | Other | Home Exercise Group |
Primary outcome
Root Mean Square(RMS)
Time frame: 12 weeks
Body right and left asymmetry will be examined.
3D Motion analysis
Time frame: 12 weeks
3D motion analysis with 4 cameras, symmetry of certain points will be evaluated during motion.
Postural Trunk Asymmetry Index (POTSI)
Time frame: 12 weeks
It is a method that allows an individual with AIS to evaluate body shape and asymmetry.
Walter Reed Visuel Assesment Scale
Time frame: 12 weeks
Walter Reed Visuel Assesment Scale (WRVAS) each aspect is shown with five levels of increasing severity of the seven type of deformity that are scored from minimum (1) to maximum (5). How individuals perceive their own cosmetic deformities and the effectiveness of treatment in improving cosmetic deformity can be evaluated
Scoliosis Research Society-22
Time frame: 12 weeks
Scoliosis Research Society (SRS-22) is a simple and practical questionnaire specific to individuals with scoliosis. The questionnaire included pain, self-image, function / activity, mental health and treatment satisfaction. There are 22 questionnaire questions, scoring from 1 to 5. The minimum score is the worst score (22).
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 2 Nov 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
KADRIYE TOMBAK study director
AKDENIZ UNIVERSITY PHYSICAL THERAPY
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 Exercise Group and Home Exercise Group in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Eastern Mediterranean 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 2 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 2 Nov 2022. 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?
Root Mean Square(RMS) (time frame: 12 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?
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 2 Nov 2022.