NCT05557773

Brief Summary

Scoliosis can be defined as a 3-dimensional deformity in which the lateral deviation and rotation of the vertebrae occur, as well as changes in the physiological curves of the spine. The gold standard criterion is that the Cobb angle, which determines the lateral deviation of the spine in the frontal plane, is greater than 10°. Postural control and balance occur as a result of the integration of many sensory information. It is thought that postural control and balance in Adolescent Idiopathic Scoliosis (AIS) patients are adversely affected by biomechanical changes in sensory input, central integration, weight transfer mechanism and the structure of the medulla spinalis. In addition to these, vestibular disorders and proprioceptive losses may have an effect on balance. Decline in balance reduces the quality of life of individuals with AIS. In addition, exercise has an important place in the treatment of individuals with AIS. In order to get more efficiency from the exercises, it is necessary to improve the balance. The aim of this study is to evaluate the changes in balance, proprioception, and knee muscle strength of patients, to determine the place of balance exercises in the treatment of individuals with AIS, and to investigate the effect of core stabilization exercises on balance and proprioception in patients with AIS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 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

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2023

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

September 24, 2022

Last Update Submit

February 6, 2025

Conditions

Keywords

adolescent idiopathic scoliosiscore stabilization exercisesbalanceproprioceptionknee muscle strength

Outcome Measures

Primary Outcomes (3)

  • Balance

    Evaluation of balance with Biodex Balance System

    8 week

  • Proprioception

    Evaluation of proprioception with Biodex System 3 Pro Multijoint System

    8 week

  • Muscle Strength of Knee Flexion / Extension

    Muscle Strength of Knee Measurement of isokinetic muscle strength with Biodex System 3Pro Multijoint System Isokinetic Dynamometer.e Flexion / Extension

    8 week

Secondary Outcomes (1)

  • Balance

    8 week

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 45 minutes.

Other: Home Based Traditional Scoliosis Exercises

Training Group

EXPERIMENTAL

In addition to conventional home based traditional scoliosis exercises, patients in this group will also receive core stabilization exercise training for 45 minutes, 5 times in a week for 8 weeks. Every two sessions will be supervised in a clinic per week.

Other: Home Based Traditional Scoliosis ExercisesOther: Core Stability Training

Interventions

Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.

Control GroupTraining Group

Patients in this group will receive traditional scoliosis exercises. In addition, the training group will receive core stabilization exercises for multifidus, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, iliopsoas, gluteus maximus, and pelvic floor muscles.

Training Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with AIS between the ages of 10-18
  • Cobb angle is between 10-40 degrees
  • The child's and family's consent to participate in the study
  • The child does not receive any other treatment that will affect his scoliosis

You may not qualify if:

  • Surgical operation in the last 3 months
  • Presence of an orthopedic, neurological, systemic disease that will prevent him from exercising
  • Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises
  • Exercising 3 or more days a week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Study Design

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

Study Record Dates

First Submitted

September 24, 2022

First Posted

September 28, 2022

Study Start

June 1, 2022

Primary Completion

February 5, 2023

Study Completion

February 23, 2023

Last Updated

February 10, 2025

Record last verified: 2023-02

Locations