NCT06875453

Brief Summary

This study aimed to investigate the effect of Detethering exercises on muscle tone in patients with adolescent idiopathic scoliosis. H1: Detethering exercises affect muscle tone in patients with adolescent idiopathic scoliosis.

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

July 10, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

10 months

First QC Date

March 9, 2025

Last Update Submit

March 9, 2025

Conditions

Keywords

scoliosisexercisemuscle tone

Outcome Measures

Primary Outcomes (2)

  • ATR - Angle of Trunk Rotation

    Measurement of the angle/degree of trunk rotation is the most appropriate method for the clinical evaluation of scoliosis. ATR can be used to monitor the effects of treatment without radiographic evaluation. ATR is measured using a special inclinometer called a scoliometer. The patient is asked to lean forward with arms relaxed. The scoliometer is placed on the back and the degree observed at each point of maximum gibbosity is recorded.

    1 week

  • Muscle Tone

    Intramuscular mechanical properties can be measured with the MyotonPRO device (Myoton Ltd., Estonia), a new diagnostic evaluation method, which measures intramuscular tension or resting muscle tone, muscle compliance, and muscle elasticity. In this study, it was shown that in conditions where electromyographic measurements are not possible, MyotonPRO measurements (viscoelastic and biomechanical properties) are used as an alternative to muscle strength and activation. The device is held upright and downward pressure is applied. When the red light on the plexiglass frame of the device probe turns green, the pressure application is stopped and the device is held stationary until 5 strokes are performed. Standard stroke intervals are used in all evaluations. During the application, care is taken to move the device and maintain the correct position. Measurements will be repeated 3 times and averaged.

    1 week

Study Arms (1)

Intervention

EXPERIMENTAL

Detethering exercises will be performed for participants with adolescent idiopathic scoliosis.

Other: Exercise

Interventions

The Schroth Best Practice program, which is widely used in the conservative treatment of scoliosis, consists of 6 modules including physiological exercises to correct the sagittal plane, activities of daily living, 3D correction techniques, powerful Schroth exercises, de-tethering exercises and gait rehabilitation. Detethering exercises in this program will be performed in this study.

Intervention

Eligibility Criteria

Age10 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Be between the ages of 10-30,
  • Being diagnosed with IS
  • Cobb angle between 20º and 50º,
  • To be able to continue the program to be implemented,
  • No chronic disease requiring the use of any neurological or psychiatric medication,
  • Parents and/or child volunteering to participate in the study.

You may not qualify if:

  • The patient has any contra-indication for exercise,
  • Previous spine surgery,
  • Having a curve with an apex thoracic 6 and above,
  • The presence of any mental problem,
  • Scoliosis is not idiopathic but has different causes (neurological, congenital, etc...), neurological, psychiatric, muscular, rheumatic or orthopedic diseases are present.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation,

Bandırma, 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 9, 2025

First Posted

March 13, 2025

Study Start

July 10, 2024

Primary Completion

April 30, 2025

Study Completion

September 30, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations