NCT05636280

Brief Summary

Although abdominal muscle thickness has been evaluated in individuals with scoliosis in the literature, there is no study in the literature reporting the relationship between abdominal muscle thickness under ultrasound as a result of schroth exercises. The aim of this study is to evaluate the effectiveness of the Schroth method on abdominal muscle thickness in people with AIS.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

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
2 months until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2023

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

November 23, 2022

Last Update Submit

April 15, 2023

Conditions

Keywords

scoliosisabdominal muscle thicknessschroth exercise

Outcome Measures

Primary Outcomes (1)

  • Assessment of Abdominal Muscle Thickness Measurement Under Ultrasound

    Abdominal muscle imaging and measurement will be performed with the participants lying on their back with the soles of the feet on the bed with the knees flexed to 90 degrees and the hips to approximately 45 degrees of flexion. The medial convex probe will be placed at the intersection point of a horizontal line drawn from the navel to the lateral and a vertical line drawn from the anterior superior iliac spine to the cranial. The probe will be placed transversely so that the medial fascia of the transversus abdominus is medial to the image and the transversus abdominus, internal oblique and external oblique muscles are well visible.

    6 weeks

Secondary Outcomes (4)

  • Assessment of Risser Sign

    6 weeks

  • Assessment of cobb angle

    6 weeks

  • Assessment of Angle of Trunk Rotation

    6 weeks

  • Assessment of Quality of Life

    6 weeks

Study Arms (2)

schroth exercise group

EXPERIMENTAL

In this study, Schroth exercise training applied 3 days a week for 6 weeks in people with Adolescent Idiopathic Scoliosis will be applied by a physiotherapist trained in schroth.

Other: schroth exercise

traditional scoliosis exercise group

ACTIVE COMPARATOR

In this study, traditional scoliosis exercise training applied 3 days a week for 6 weeks in people with Adolescent Idiopathic Scoliosis will be applied by a physiotherapist.

Other: traditional scoliosis exercise

Interventions

In this study, Schroth exercise training applied 3 days a week for 6 weeks in people with Adolescent Idiopathic Scoliosis will be applied by a physiotherapist trained in schroth.

schroth exercise group

In this study, traditional scoliosis exercise training applied 3 days a week for 6 weeks in people with Adolescent Idiopathic Scoliosis will be applied by a physiotherapist.

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 had previous spine surgery and abdominal 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)

Zeynep Ayyıldız Eroğlu

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 25, 2023

Primary Completion

June 8, 2023

Study Completion

September 8, 2023

Last Updated

April 19, 2023

Record last verified: 2023-04

Locations