NCT06083714

Brief Summary

Idiopathic scoliosis is a three-dimensional deformity of the spine that accounts for approximately 70% of all scoliosis anomalies, and adolescent idiopathic scoliosis (AIS) is the most common type. AIS not only changes the shape of the trunk, but also the relationships between body parts. Considering the close anatomical relationship between the scapula and the rib cage, AIS is associated with changes in scapular position and orientation. Scapular stabilization exercises; these are exercises that aim to restore the position and orientation of the scapula and the motor control and movement pattern of the muscles, thus providing scapula stability for better shoulder kinematics. There are studies reporting that scapular stabilization exercises should be included in the rehabilitation program of patients with scapular dyskinesia and various shoulder pathologies. However, no study has been found in the literature examining the effects of scapular stabilization exercises on changes in scapular position, shoulder imbalance and curve severity seen in scoliosis. Therefore, the aim of the study is to investigate the effect of scapular stabilization exercises applied in addition to Schroth exercises used in the treatment of individuals with AIS, on scoliosis severity, scapula position and shoulder imbalance.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

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

October 9, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

October 9, 2023

Last Update Submit

May 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Scoliosis Severity

    In determining the degree of curvature, the Cobb angle obtained from the spine x-ray taken in the antero-posterior direction and containing the entire spine will be accepted as the standard measurement method. End vertebral levels will be recorded on the antero-posterior x-ray. Lines perpendicular to the upper end plate of the upper end vertebra and the lower end plate of the lower end vertebra will be drawn and the angle formed between these lines will be recorded as the Cobb angle.

    Change from baseline at 8 weeks

Secondary Outcomes (10)

  • Axial Trunk Rotation

    Change from baseline at 8 weeks

  • Scapula Position-XRay

    Change from baseline at 8 weeks

  • Scapula Position-Lateral Scapula Slide Test

    Change from baseline at 8 weeks

  • Scapula Position-Scapular Index

    Change from baseline at 8 weeks

  • Periscapular Muscle Strength

    Change from baseline at 8 weeks

  • +5 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

Participants in this group will receive scapular stabilization exercises in addition to Schroth exercises specific to scoliosis.

Other: Scapular Stabilization ExercisesOther: Schroth Exercises

Group 2

ACTIVE COMPARATOR

Participants in this group will receive Schroth exercises specific to scoliosis only.

Other: Schroth Exercises

Interventions

Home-based scapular stabilization exercises (Inferior Glide, Low Row, Scapular Clock, Wall Push Up, Wall Slide and Squat Robbery) will be performed once or twice a day, 3 sets x 20 repetitions, 3 days a week for 8 weeks.

Group 1

It will be implemented face to face, 3 days a week, each session lasting approximately 45 minutes and in 8-week programs.

Group 1Group 2

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with adolescent idiopathic scoliosis,
  • Having Cobb angle between 10°-30°,
  • Those with main thoracic curvature,
  • Risser stage between 0-3,
  • Volunteer individuals

You may not qualify if:

  • Individuals who have had surgery related to the spine and upper extremity,
  • Using a supra-axillary trunk orthosis,
  • Having any systemic or neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University

Ankara, Çankaya, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 16, 2023

Study Start

March 30, 2024

Primary Completion

August 30, 2024

Study Completion

October 30, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations