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The Effect of the Core Stabilization Training on Respiratory Parameters , Functional Capacity and Balance in Scoliosis

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home Based Traditional Scoliosis Exercise
Home Based Core Stabilization Training
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent idiopathic scoliosis, Scoliosis, Core Stabilization Training, Exercise Training, Pulmonary Function Test, 6 - Minute Walk Test, Peripheral Muscle Strength, Balance with Biodex, Quality of Life

Eligibility Criteria

10 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adolescent Idiopathic Scoliosis diagnosis

Exclusion Criteria:

  • Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessments results.
  • Subjects previously undertaken any of spinal surgeries.
  • Subjects involved in exercise training 3 or more days a week.

Sites / Locations

  • Bezmialem Vakıf University

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 30 minutes. The content of the physiotherapy program; posture, interscapular muscle strengthening, stretching and lateral flexion exercises are formed.

In addition to home based traditional scoliosis exercise, the training group will also receive core stabilization exercise training for 8 weeks, 5 days a week, for 30 minutes. Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and latissimus dorsi.

Outcomes

Primary Outcome Measures

Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks
Change from baseline Peripheral Muscle strength at 8 weeks
Change from baseline Balance at 8 weeks
Change from baseline distance covered in Six- Minute Walk Test at 8 weeks

Secondary Outcome Measures

Change from baseline axial trunk rotation (ATR)
Measurements will be applied with Bunnell Scoliometer by physiotherapist.

Full Information

First Posted
January 28, 2019
Last Updated
November 12, 2020
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03823053
Brief Title
The Effect of the Core Stabilization Training on Respiratory Parameters , Functional Capacity and Balance in Scoliosis
Official Title
The Effect of Core Stabilization Training on Respiratory Parameters, Peripheral Muscle Strength, Balance, Functional Capacity and Quality of Life in Children With Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif 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
The vertebral column is a structure that transfers the weight of the head and torso to the lower extremity, provides trunk movements and protects the spinal cord.A three dimensional deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above, including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the closure of growth plates. Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ disorders and pain. In addition, the quality of life in these individuals is also seen to decrease.Children with adolescent idiopathic scoliosis have inadequate respiratory function and a decrease in functional capacity. At the same time, these children show muscle weakness in certain parts of the body. The aim of this study was to investigate the relationship between home based core stabilization training, respiratory parameters, peripheral muscle strength, balance, functional capacity and quality of life in individuals with young scoliosis. The investigators suggest that the addition of core stabilization training to children with mild and moderate adolescent idiopathic scoliosis will produce good results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Adolescent idiopathic scoliosis, Scoliosis, Core Stabilization Training, Exercise Training, Pulmonary Function Test, 6 - Minute Walk Test, Peripheral Muscle Strength, Balance with Biodex, Quality of Life

7. Study Design

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

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 30 minutes. The content of the physiotherapy program; posture, interscapular muscle strengthening, stretching and lateral flexion exercises are formed.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
In addition to home based traditional scoliosis exercise, the training group will also receive core stabilization exercise training for 8 weeks, 5 days a week, for 30 minutes. Core stabilization training; exercises for 2 muscle systems that contribute to spinal stability are given. The first one is the "local system" muscles; multifidus, transversus abdominis, diaphragm and pelvic floor muscles. The second, the "global system" includes large superficial muscles, such as erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and latissimus dorsi.
Intervention Type
Other
Intervention Name(s)
Home Based Traditional Scoliosis Exercise
Intervention Description
Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. Exercises will be applied 1 sets of 10 repetitions and once a day.
Intervention Type
Other
Intervention Name(s)
Home Based Core Stabilization Training
Intervention Description
Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. In addition, the training group received core stabilization exercises for multifidus, transversus abdominis, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and pelvic floor muscles.Exercises will be applied 1 sets of 10 repetitions and once a day.
Primary Outcome Measure Information:
Title
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Peripheral Muscle strength at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Balance at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline distance covered in Six- Minute Walk Test at 8 weeks
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Change from baseline axial trunk rotation (ATR)
Description
Measurements will be applied with Bunnell Scoliometer by physiotherapist.
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adolescent Idiopathic Scoliosis diagnosis Exclusion Criteria: Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessments results. Subjects previously undertaken any of spinal surgeries. Subjects involved in exercise training 3 or more days a week.
Facility Information:
Facility Name
Bezmialem Vakıf University
City
Istanbul
State/Province
Eyüp
ZIP/Postal Code
34050
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35859288
Citation
Yildirim S, Ozyilmaz S, Elmadag NM, Yabaci A. Effects of Core Stabilization Exercises on Pulmonary Function, Respiratory Muscle Strength, Peripheral Muscle Strength, Functional Capacity, and Perceived Appearance in Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Aug 1;101(8):719-725. doi: 10.1097/PHM.0000000000001984. Epub 2022 Feb 2.
Results Reference
derived

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The Effect of the Core Stabilization Training on Respiratory Parameters , Functional Capacity and Balance in Scoliosis

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