NCT04203394

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

December 16, 2019

Last Update Submit

October 31, 2022

Conditions

Scoliosis IdiopathicScoliosis; Adolescence

Keywords

Schroth exercise, conservative treatment, scoliosis

Outcome Measures

Primary Outcomes (5)

  • Root Mean Square(RMS)

    Body right and left asymmetry will be examined.

    12 weeks

  • 3D Motion analysis

    3D motion analysis with 4 cameras, symmetry of certain points will be evaluated during motion.

    12 weeks

  • Postural Trunk Asymmetry Index (POTSI)

    It is a method that allows an individual with AIS to evaluate body shape and asymmetry.

    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

    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).

    12 weeks

Study Arms (2)

Schroth Exercise Group

EXPERIMENTAL

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

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

Other: Home Exercise Group

Interventions

Schroth Exercise GroupOTHER

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

Schroth Exercise Group
Home Exercise GroupOTHER

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

Home Exercise Group

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients with scoliosis diagnosed and followed up by the attending physician
  • age group,
  • Patients who voluntarily agreed to participate in the study
  • Living in Antalya/TURKEY

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University Physical Therapy and Rehabilitation

Antalya, Konyaalti, 07100, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • KADRIYE TOMBAK

    AKDENIZ UNIVERSITY PHYSICAL THERAPY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 18, 2019

Study Start

August 18, 2019

Primary Completion

January 30, 2021

Study Completion

May 30, 2021

Last Updated

November 2, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)