NCT06689735

Brief Summary

The aim of this study is to examine the effectiveness of Schroth exercises and Pilates exercises in patients with scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

November 12, 2024

Last Update Submit

June 24, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • The Pittsburgh Sleep Quality Index (PSQI)

    Pittsburgh Sleep Quality Index; It evaluates sleep duration, sleep disturbance, sleep efficiency, subjective sleep quality, sleep medication use, daytime dysfunction, and sleep delay and consists of a total of 24 questions. 19 of them are self-report scales and 5 of them consist of questions to be answered by a friend or spouse. There are 7 components with 18 questions scored in the scale, and each component is evaluated between 0 and 3 points. The total score ranges from 0 to 21, and 5 or more is an indicator of "poor sleep quality".

    14 weeks

  • Scoliosis Research Society-22

    Scoliosis Research Society-22 is a functional survey for the patient to fill out on their scoliosis. This survey has been validated in the literature. It is a 22 question survey on the functional status and pain that a patient experiences. Created by the scoliosis research society. There is a scoring rubric that goes with the survey. This survey has 5 domains that are covered with the minimum score of 22 and the maximum score of 110. The higher the score the better the patient is doing in the domains of: Activities of Daily Living, Mental Health, Pain, Patient Satisfaction, Positive Affect, Quality of Life, Social Relationships, and Stress/Coping.

    14 weeks

  • Scoliometer Degree

    The degree of rotation measured clinically with a scoliometer

    At time of enrollment

  • Walter Reed Visual Assessment Scale

    Walter Reed Visual Assessment Scale (WRGDS) is an evaluation scale created from visual figures. It was developed by Pineda et al. in 2006, for use in individuals with scoliosis, to measure how a person thinks about the deformity in their own body and how severe it is perceived.

    14 weeks

Study Arms (2)

Schroth

EXPERIMENTAL

3D corrective scoliosis exercises

Other: schroth exercises

Pilates

EXPERIMENTAL

Pilates exercises

Other: pilates exercises

Interventions

Exercises will be given in lying, sitting and standing positions. In each exercise, elongation of the spine will be ensured and the person will be positioned according to the type of scoliosis. Exercises will be given progressively in supine, prone, side sitting, sitting and standing positions. In each exercise, elongation of the spine will be ensured and the person will be positioned according to the upper and lower extremities. Progress in the exercises will be made positionally by increasing the number of repetitions and the number of rotational breathing during the exercise.

Schroth

The average application time of the exercises is 30-40 minutes (with the first 10 minutes of warming up and the last 5 minutes of stretching). The first four exercises were used for the warm-up period and the last four exercises were used for the stretching period. The exercises will be done as 1 set of 8 repetitions. The Hundred exercise will be increased to 10 sets of 10 reps every two weeks to 10 reps, 12 reps, and 14 reps, respectively.

Pilates

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 18-45 years of age
  • Having a primary curve between 10-40 degrees according to the Cobb method
  • Having typical S or C scoliosis
  • Being willing to participate in the study
  • Having the cognitive capacity to cooperate with the guidance of a physiotherapist

You may not qualify if:

  • Having a BMI over 30 kg/m²
  • Having any neurological, orthopedic, cardiopulmonary disorders other than the diagnosis of scoliosis
  • Having any injuries related to the musculoskeletal system in the last 6 months
  • Being unable to fulfill exercise requirements for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MG Clinic

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Karavidas N, Iakovidis P, Chatziprodromidou I, Lytras D, Kasimis K, Kyrkousis A, Apostolou T. Physiotherapeutic Scoliosis-Specific Exercises (PSSE-Schroth) can reduce the risk for progression during early growth in curves below 25 degrees : prospective control study. Eur J Phys Rehabil Med. 2024 Apr;60(2):331-339. doi: 10.23736/S1973-9087.24.08177-2. Epub 2024 Mar 19.

    PMID: 38502554BACKGROUND
  • Manzak Dursun AS, Ozyilmaz S, Ucgun H, Elmadag NM. The effect of Pilates-based exercise applied with hybrid telerehabilitation method in children with adolescent idiopathic scoliosis: A randomized clinical trial. Eur J Pediatr. 2024 Feb;183(2):759-767. doi: 10.1007/s00431-023-05340-2. Epub 2023 Nov 23.

    PMID: 37993666BACKGROUND
  • Zhang P, Shen X, Zhang L, Wang S, Wu Q. Effect of sling exercise combined with Schroth therapy on adolescents with mild idiopathic scoliosis: A twelve-week randomized controlled trial. J Back Musculoskelet Rehabil. 2024;37(2):379-388. doi: 10.3233/BMR-230102.

    PMID: 38043003BACKGROUND

MeSH Terms

Conditions

Scoliosis

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Mehmet Ali Gümüş

    Uskudar University

    STUDY CHAIR
  • Berna Karamancıoğlu, M.Sc.

    Uskudar University

    STUDY CHAIR
  • Beyzanur Dikmen Hoşbaş, M.Sc.

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 14, 2024

Study Start

November 15, 2024

Primary Completion

February 20, 2025

Study Completion

June 23, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations