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Oxygen Consumption in Adolescent Idiopathic 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. Identifier: NCT03514082
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : January 31, 2019
Information provided by (Responsible Party):
Yasin YURT, Eastern Mediterranean University

Brief Summary:
Adolescent Idiopathic Scoliosis (AIS) is a rotational deformity of the spine that could be seen 2-3% of population. Conservative treatment of AIS with 20-45 degree lateral flexion angle (Cobb) includes brace and therapeutic exercises. Some gait abnormalities were defined like decreased torsional movements of spine, increased muscular work and energy expenditure in AIS. Additionally wearing a brace limits pelvic motions and affects pendulum-like mechanism of gait. Our aim was to investigate gait energy consumption, pulmonary functions, balance and lower extremity loading symmetry in AIS subjects who are getting conservative treatment.

Condition or disease Intervention/treatment
Adolescent Idiopathic Scoliosis Device: Rigid Thermoplastic Spinal Brace

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Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Conservative Treatment on Pulmonary Functions, Gait Oxygen Consumption Balance and Lower Limb Load Distribution in Adolescents With Idiopathic Scoliosis
Actual Study Start Date : April 15, 2018
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Adolescent Idiopathic Scoliosis
Subjects with AIS who are beginning to the conservative treatment.
Device: Rigid Thermoplastic Spinal Brace
Custom made rigid thermoplastic brace with 23 hours daily wearing time.

Primary Outcome Measures :
  1. Gait Oxygen Consumption [ Time Frame: Assessment will be done at the end of first month of conservative treatment. ]
    Oxygen consumption will be assessed with a mobile metabolic analyzer during walking on treadmill with 4 km/h gait speed. Recordings will be taken for 2 minutes after first 2 minutes of walking.

Secondary Outcome Measures :
  1. Pulmonary Functions [ Time Frame: Assessment will be done at the end of first month of conservative treatment. ]
    Forced vital capacity (FVC), Forced expiratory volume in one second (FEV1), FEV1/FVC ratio, peak expiratory flow (PEF), forced expiratory flow at 25-75 % of the pulmonary volume (FEF 25-75%) will be assessed with spirometer.

  2. Balance [ Time Frame: Assessment will be done at the end of first month of conservative treatment. ]
    Balance will be assessed with a special equipment that gives deviation that lower values mean better.

  3. Lower extremity loading symmetry [ Time Frame: Assessment will be done at the end of first month of conservative treatment. ]
    Plantar loading symmetry will be assessed with a pedobarograph located in the middle of a six meters walking way. Loading symmetry will be calculated and compared as percentage of total pressure.

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subject who come to our outpatient clinic will be assessed for eligibility.

Inclusion Criteria:

  • Cobb angle between 20-45 degree,
  • Prescribed a rigid spinal brace by doctor

Exclusion Criteria:

  • Having leg length discrepancy more than 1 centimeter
  • Having a lung disease
  • Having another orthopedic or neurologic disorder

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 identifier (NCT number): NCT03514082

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Eastern Mediterranean University
Mersin, Famagusta, Turkey, 99628
Sponsors and Collaborators
Eastern Mediterranean University
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Principal Investigator: Yasin Yurt, Asst. Prof. Eastern Mediterranean University
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Responsible Party: Yasin YURT, Assistant Professor, Eastern Mediterranean University Identifier: NCT03514082    
Other Study ID Numbers: ETK00-2016-0141
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases