- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04203394
Comparison of the Effects of Controlled Schroth Exercise and Home Exercise Programs
Comparison of the Effects of Controlled Schroth Exercise and Home Programs on Body Symmetry, Deformity Perception and Quality of Life in Adolescent Idiopathic Scoliosis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Konyaalti
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Antalya, Konyaalti, Turkey, 07100
- Akdeniz University Physical Therapy and Rehabilitation
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Schroth Exercise Group
12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise
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12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise
|
EXPERIMENTAL: Home Exercise Group
Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise
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Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Root Mean Square(RMS)
Time Frame: 12 weeks
|
Body right and left asymmetry will be examined.
|
12 weeks
|
3D Motion analysis
Time Frame: 12 weeks
|
3D motion analysis with 4 cameras, symmetry of certain points will be evaluated during motion.
|
12 weeks
|
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.
|
12 weeks
|
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
|
12 weeks
|
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).
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: KADRIYE TOMBAK, AKDENIZ UNIVERSITY PHYSICAL THERAPY
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02.04.2018 2018/57-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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