NCT05637723

Brief Summary

The aim of this study is to evaluate the effect of Schroth exercise training and Traditional Scoliosis exercise training applied 3 days a week for 6 weeks in people with Adolescent Idiopathic Scoliosis on the pelvic floor muscles and to compare these results with the control group, to evaluate pelvic asymmetry, pain, posture, body awareness, flexibility and life expectancy. It will be planned as a prospective randomized controlled trial to evaluate the correlation between 3 groups on the quality of life.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

November 23, 2022

Last Update Submit

April 1, 2024

Conditions

Keywords

scoliosispelvic floor muscleschroth exercise

Outcome Measures

Primary Outcomes (2)

  • Assessment of pelvic floor muscle strength

    The ability of the pelvic floor muscles to contract and relax is evaluated by contraction and relaxation of the pubococcygeal muscles around the vagina and anus. In our study, we will try to determine the change in pelvic floor muscle activity before and after Schroth treatment using EMG Biofeedback device. EMG Biofeedback will be used for evaluation purposes.

    6 weeks

  • Assessment of cobb angle

    The degree of curvature in the coronal plane is measured radiographically according to the Cobb method. The Cobb angle, considered the gold standard, is the angle between the perpendiculars when descending lines drawn from the top of the curve along the upper endplate of the most tilting vertebra at the top and the lines drawn under the lower endplate of the most tilting vertebrae to the bottom. The Cobb angle describes only one plane of a three-dimensional deformity, but provides information about the progression of the curvature. Observer variability was recorded as 2.8°-4.9° and interobserver variability was recorded as 6.3°-7.2° in Cobb angle measurement with conventional techniques. In digital Cobb angle measurements, the variability for the same observer and the interobserver variability were reported as 1.3°. In the study, it is planned to evaluate the Cobb angle by the relevant physician.

    6 weeks

Secondary Outcomes (10)

  • Assessment of Risser sign

    6 weeks

  • Assessment of Angle of Trunk Rotation

    6 weeks

  • Assessment of trunk flexibility

    6 weeks

  • Assessment of Posture

    6 weeks

  • Assessment of Body Awareness

    6 weeks

  • +5 more secondary outcomes

Study Arms (3)

schroth exercise group

EXPERIMENTAL

Included participants will be included in the Schroth exercise program by a Schroth-trained physiotherapist 3 days a week for 6 weeks, after being evaluated at the start of treatment.

Other: schroth exercise

traditional scoliosis exercise group

ACTIVE COMPARATOR

Included participants will be included in the traditional scoliosis exercise program by a physiotherapist 3 days a week for 6 weeks, after being evaluated at the start of treatment.

Other: traditional scoliosis exercises

control group

NO INTERVENTION

Any exercise program for scoliosis will not be applied to this group.

Interventions

The schroth exercise program will be given 3 days a week for 6 weeks.

schroth exercise group

The traditional scoliosis exercises program will be given 3 days a week for 6 weeks.

traditional scoliosis exercise group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Having been diagnosed with idiopathic scoliosis by a specialist physician,
  • years old,
  • The primary curvature is between 10-45 degrees according to the Cobb method,
  • C or S scoliosis,
  • Pain in the back/lumbar region due to scoliosis,
  • Those who have not received any exercise therapy for scoliosis before,
  • Volunteer to participate in the study,
  • Having the cognitive capacity to cooperate with the guidance of the physiotherapist,
  • Have not had any musculoskeletal injury in the last 6 months,
  • No neurological, orthopedic or cardiopulmonary disorders other than the diagnosis of scoliosis,
  • Young individuals who have not undergone any surgery related to the diagnosis of scoliosis will be included in the study.

You may not qualify if:

  • The patient has any contraindications for exercise,
  • Having previously undergone spine surgery and pelvic surgery,
  • Having any mental problems,
  • The fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital),
  • In case of neurological, psychiatric, muscular, rheumatic or orthopedic diseases, these people will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of health sciences Istanbul physical therapy and rehabilitation training and research hospital

Istanbul, Bahcelievler, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Schreiber S, Parent EC, Khodayari Moez E, Hedden DM, Hill DL, Moreau M, Lou E, Watkins EM, Southon SC. Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis - an Assessor and Statistician Blinded Randomized Controlled Trial. PLoS One. 2016 Dec 29;11(12):e0168746. doi: 10.1371/journal.pone.0168746. eCollection 2016.

    PMID: 28033399BACKGROUND
  • Rigo M, Reiter Ch, Weiss HR. Effect of conservative management on the prevalence of surgery in patients with adolescent idiopathic scoliosis. Pediatr Rehabil. 2003 Jul-Dec;6(3-4):209-14. doi: 10.1080/13638490310001642054.

    PMID: 14713587BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Esra Pehlivan, assoc. prof.

CONTACT

Zeynep Ayyıldız Eroğlu, MSc PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Physiotherapist

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 5, 2022

Study Start

January 15, 2023

Primary Completion

April 30, 2024

Study Completion

May 1, 2024

Last Updated

April 2, 2024

Record last verified: 2024-04

Locations