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.|
|ClinicalTrials.gov Identifier: NCT03514082|
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment|
|Adolescent Idiopathic Scoliosis||Device: Rigid Thermoplastic Spinal Brace|
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|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|
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.
- 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.
- 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.
- 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.
- 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.
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): NCT03514082
|Eastern Mediterranean University|
|Mersin, Famagusta, Turkey, 99628|
|Principal Investigator:||Yasin Yurt, Asst. Prof.||Eastern Mediterranean University|