NCT06716957

Brief Summary

The aim of this study is to examine the effectiveness of stabilization exercises integrated with Schroth exercises on quality of life, trunk rotation angle, body awareness and sleep quality in young people with scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

December 13, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

November 29, 2024

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Scoliosis Research Society-22

    It is a scoliosis-specific, valid and reliable quality of life scale that questions pain, body image perception, function/activity, mental health, and satisfaction with treatment. A minimum of 1 point (worst) and a maximum of 5 points (best) are taken for each question. Scoring is obtained by dividing the total score from each section by the number of questions in that section. As a result of the scoring, it is accepted that the higher the score, the higher the quality of life.

    14 weeks

  • Walter Reed Visual Assessment

    It is a valid scale consisting of 7 questions, each of which includes 5 visuals and evaluates the physical deformity perceived by the patients.The selected images are scored as the lowest "1" and the highest "5", and the highest total score is 35 and the lowest is 5. It is accepted that the higher the score, the more negative-evil perception of the deformity.

    14 weeks

  • Pittsburgh Sleep Quality Index

    The scale includes a total of 24 questions. 19 of these questions are self-evaluation questions, and 5 of them are answered by the individual's spouse or a roommate. These 5 questions are used for clinical information only and are not included in the scoring. The scale questions that determine sleep quality include various factors related to sleep quality. These questions are to determine sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems; 18 items were grouped as 7 component scores. The total score ranges from 0 to 21. A high total score indicates poor sleep quality. The scale does not indicate the presence of sleep disorders or the prevalence of sleep disorders. However, it is stated that a total score of 5 and above indicates poor sleep quality.

    14 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

Schroth exercises

Other: Schroth exercise

exercise

EXPERIMENTAL

Schroth exercise and dynamic stabilization exercises

Other: Schroth exerciseOther: Dynamic Stabilization 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.

controlexercise

The dynamic neuromuscular stabilization group will receive developmental postures based on developmental kinesiology. It will involve a supine 3month Position, side-lying Position, Quadruped, oblique sitting, bear position, squat Position. Each position will be performed for 30-60 s for five reps, active exercise 5-10 reps under supervision for two days/week, and unsupervised for 3 days/week for 12 weeks

exercise

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being between 9-17 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 had 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)

Bursa Eforfiz Healthy Living Center

Bursa, Turkey (Türkiye)

Location

Related Publications (3)

  • Almahmoud OH, Baniodeh B, Musleh R, Asmar S, Zyada M, Qattousah H. Overview of adolescent idiopathic scoliosis and associated factors: a scoping review. Int J Adolesc Med Health. 2023 Nov 21;35(6):437-441. doi: 10.1515/ijamh-2023-0166. eCollection 2023 Dec 1.

    PMID: 37982659BACKGROUND
  • Mohamed N, Acharya V, Schreiber S, Parent EC, Westover L. Effect of adding Schroth physiotherapeutic scoliosis specific exercises to standard care in adolescents with idiopathic scoliosis on posture assessed using surface topography: A secondary analysis of a Randomized Controlled Trial (RCT). PLoS One. 2024 Apr 30;19(4):e0302577. doi: 10.1371/journal.pone.0302577. eCollection 2024.

    PMID: 38687741BACKGROUND
  • Gan X, Liu X, Cai D, Zhang R, Li F, Fang H, Huang J, Qiu C, Zhan H. Wearable accelerometers reveal objective assessment of walking symmetry and regularity in idiopathic scoliosis patients. PeerJ. 2024 Jul 16;12:e17739. doi: 10.7717/peerj.17739. eCollection 2024.

    PMID: 39035168BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Sude Asya ALŞAN MOVAHHEDİ

    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 29, 2024

First Posted

December 4, 2024

Study Start

December 13, 2024

Primary Completion

March 15, 2025

Study Completion

June 20, 2025

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations