NCT07250295

Brief Summary

The study population comprised patients with AIS who had applied to the outpatient clinic between January and June 2022. The patients were divided into two groups. Treatment group(TG) was instructed in specific scoliosis exercises, while the Control group(CG) was given exercises for the lower extremities. Each patient was included in a 12- week exercise program accompanied by a physiotherapist. The patients' quality of life, and paravertebral muscles were evaluated ultrasonographically before and after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2025

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

November 18, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

ExerciseMusclesScoliosisUltrasound

Outcome Measures

Primary Outcomes (2)

  • Paravertebral Muscle Thickness in Ultrasonographic Measurements

    A standard imaging protocol was employed for the transverse imaging of the thoracic and lumbar multifidus muscles. Pre- and post-exercise measurements were performed by the same physician who was blinded to the exercise program the patient received. This evaluator was a PMR physician with 3 years of experience in the field of ultrasound. For each ultrasound image, the examiner positioned the probe over the spinous process and then moved it laterally and proceeded to image the multifidus and deep thoracic paravertebral muscles on both the convex and concave sides of the apex with the patient positioned prone. Two images were obtained for each segment on each side. The mean of the two trials was employed for the purpose of data analysis.

    12 weeks

  • The Turkish version of the Spinal Appearance Questionnaire (Tr-SGA)

    The questionnaire comprises two distinct sections: one pertaining to appearance and the other to expectations. Each section contains a series of questions presented on a 5-point Likert scale.

    12 weeks

Secondary Outcomes (1)

  • The Short Form-36 Health Status Questionnaire (SF-36)

    12 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

The treatment group (TG) was given exercises for the thoracic and lumbar regions for scoliosis.

Other: Exercise

Control Group

PLACEBO COMPARATOR

The control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises.

Other: Exercise for Lower Extremities

Interventions

Patients were expected to attend treatment under the supervision of a physiotherapist. If they missed a day, they were contacted by phone and advised to do their exercises at home. The number of days they missed did not exceed five. Each set included a 30-second rest period to prevent fatigue. A five-minute warm-up and cool-down period was allotted before and after the exercise session. The exercise program was implemented by a physiotherapist with three years of experience in scoliosis management. Before initiating the intervention, the physiotherapist underwent a structured training session, including practical demonstrations, supervised practice, and detailed exercise protocols.

Treatment Group

The control group (CG) was instructed to perform gluteus maximus, hamstring, and quadriceps strengthening exercises.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Patients who had been diagnosed with AIS by means of radiographic and clinical examination of the spine were included in the study.

You may not qualify if:

  • Cases with a history of surgery to the paravertebral region
  • Metabolic bone disease
  • Neuromuscular disease
  • chromosomal anomaly
  • Serious autoimmune and endocrine disease
  • Congenital scoliosis
  • Skeletal dysplasia and serious cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityScoliosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Principal Investigator

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 26, 2025

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

August 15, 2022

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations