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Comparison of the Effects of Controlled Schroth Exercise and Home Exercise Programs

Primary Purpose

Scoliosis Idiopathic, Scoliosis; Adolescence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Schroth Exercise Group
Home Exercise Group
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis Idiopathic focused on measuring Schroth exercise, conservative treatment, scoliosis

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Akdeniz University Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Schroth Exercise Group

Home Exercise Group

Arm Description

12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise

Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise

Outcomes

Primary Outcome Measures

Root Mean Square(RMS)
Body right and left asymmetry will be examined.
3D Motion analysis
3D motion analysis with 4 cameras, symmetry of certain points will be evaluated during motion.
Postural Trunk Asymmetry Index (POTSI)
It is a method that allows an individual with AIS to evaluate body shape and asymmetry.
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
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).

Secondary Outcome Measures

Full Information

First Posted
December 16, 2019
Last Updated
October 31, 2022
Sponsor
Eastern Mediterranean University
Collaborators
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04203394
Brief Title
Comparison of the Effects of Controlled Schroth Exercise and Home Exercise Programs
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 18, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Mediterranean University
Collaborators
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis Idiopathic, Scoliosis; Adolescence
Keywords
Schroth exercise, conservative treatment, scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schroth Exercise Group
Arm Type
Experimental
Arm Description
12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise
Arm Title
Home Exercise Group
Arm Type
Experimental
Arm Description
Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise
Intervention Type
Other
Intervention Name(s)
Schroth Exercise Group
Intervention Description
12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise
Intervention Type
Other
Intervention Name(s)
Home Exercise Group
Intervention Description
Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise
Primary Outcome Measure Information:
Title
Root Mean Square(RMS)
Description
Body right and left asymmetry will be examined.
Time Frame
12 weeks
Title
3D Motion analysis
Description
3D motion analysis with 4 cameras, symmetry of certain points will be evaluated during motion.
Time Frame
12 weeks
Title
Postural Trunk Asymmetry Index (POTSI)
Description
It is a method that allows an individual with AIS to evaluate body shape and asymmetry.
Time Frame
12 weeks
Title
Walter Reed Visuel Assesment Scale
Description
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
Time Frame
12 weeks
Title
Scoliosis Research Society-22
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KADRIYE TOMBAK
Organizational Affiliation
AKDENIZ UNIVERSITY PHYSICAL THERAPY
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University Physical Therapy and Rehabilitation
City
Antalya
State/Province
Konyaalti
ZIP/Postal Code
07100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://link.springer.com/content/pdf/10.1007/s00586-021-06769-5.pdf
Description
Related Info

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Comparison of the Effects of Controlled Schroth Exercise and Home Exercise Programs

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