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The Effects of Core Stability Training on Balance in Children With Adolescent Idiopathic Scoliosis

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home Based Traditional Scoliosis Exercises
Core Stability Training
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Balance, Proprioception, Exercise

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Istanbul UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Training Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Balance
Evaluation of balance with Biodex Balance System
Proprioception
Evaluation of proprioception with Biodex System 3 Pro Multijoint System

Secondary Outcome Measures

Balance
Evaluation of balance with Unipedal Stance Test
Proprioception
Evaluation of proprioception with Unterberger Test
Balance
Evaluation of balance with Modified Rhomberg Test

Full Information

First Posted
September 24, 2022
Last Updated
September 24, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05557773
Brief Title
The Effects of Core Stability Training on Balance in Children With Adolescent Idiopathic Scoliosis
Official Title
The Effects of Core Stability Training on Balance in Children With Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 and proprioception 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Balance, Proprioception, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will be given home based traditional scoliosis exercise training for 8 weeks, 5 days a week for 45 minutes.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home Based Traditional Scoliosis Exercises
Intervention Description
Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.
Intervention Type
Other
Intervention Name(s)
Core Stability Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Balance
Description
Evaluation of balance with Biodex Balance System
Time Frame
8 week
Title
Proprioception
Description
Evaluation of proprioception with Biodex System 3 Pro Multijoint System
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Balance
Description
Evaluation of balance with Unipedal Stance Test
Time Frame
8 week
Title
Proprioception
Description
Evaluation of proprioception with Unterberger Test
Time Frame
8 week
Title
Balance
Description
Evaluation of balance with Modified Rhomberg Test
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuat Gökdemir
Phone
+905543727084
Email
fuatgokdemir95@gmail.com
Facility Information:
Facility Name
Istanbul University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuat Gokdemir
Phone
+905543727084
Email
fuatgokdemir95@gmail.com

12. IPD Sharing Statement

Learn more about this trial

The Effects of Core Stability Training on Balance in Children With Adolescent Idiopathic Scoliosis

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