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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823053
Recruitment Status : Completed
First Posted : January 30, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bezmialem Vakif University

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.


Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Other: Home Based Traditional Scoliosis Exercise Other: Home Based Core Stabilization Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : March 25, 2019
Actual Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Active Comparator: Control Group
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.
Other: Home Based Traditional Scoliosis Exercise
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.

Experimental: Training Group
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.
Other: Home Based Traditional Scoliosis Exercise
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.

Other: Home Based Core Stabilization Training
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 Measures :
  1. Change from baseline Forced Vital Capacity (FVC) at 8 weeks [ Time Frame: Eight weeks ]
  2. Change from baseline Forced Expiratory volume in 1 second (FEV1)at 8 weeks [ Time Frame: Eight weeks ]
  3. Change from baseline Peripheral Muscle strength at 8 weeks [ Time Frame: Eight weeks ]
  4. Change from baseline Balance at 8 weeks [ Time Frame: Eight weeks ]
  5. Change from baseline distance covered in Six- Minute Walk Test at 8 weeks [ Time Frame: Eight weeks ]

Secondary Outcome Measures :
  1. Change from baseline axial trunk rotation (ATR) [ Time Frame: Eight weeks ]
    Measurements will be applied with Bunnell Scoliometer by physiotherapist.



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Ages Eligible for Study:   10 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823053


Locations
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Turkey
Bezmialem Vakıf University
Istanbul, Eyüp, Turkey, 34050
Sponsors and Collaborators
Bezmialem Vakif University

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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03823053    
Other Study ID Numbers: BVUsyildirim01
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bezmialem Vakif University:
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
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases