Oxygen Consumption in Adolescent Idiopathic Scoliosis
Effect of Conservative Treatment on Pulmonary Functions, Gait Oxygen Consumption Balance and Lower Limb Load Distribution in Adolescents With Idiopathic Scoliosis
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2018
CompletedFirst Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2019
CompletedJanuary 31, 2019
January 1, 2019
9 months
April 20, 2018
January 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Gait Oxygen Consumption
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.
Assessment will be done at the end of first month of conservative treatment.
Secondary Outcomes (3)
Pulmonary Functions
Assessment will be done at the end of first month of conservative treatment.
Balance
Assessment will be done at the end of first month of conservative treatment.
Lower extremity loading symmetry
Assessment will be done at the end of first month of conservative treatment.
Study Arms (1)
Adolescent Idiopathic Scoliosis
Subjects with AIS who are beginning to the conservative treatment.
Interventions
Custom made rigid thermoplastic brace with 23 hours daily wearing time.
Eligibility Criteria
Subject who come to our outpatient clinic will be assessed for eligibility.
You may qualify if:
- Cobb angle between 20-45 degree,
- Prescribed a rigid spinal brace by doctor
You may not qualify if:
- Having leg length discrepancy more than 1 centimeter
- Having a lung disease
- Having another orthopedic or neurologic disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern Mediterranean University
Mersin, Famagusta, 99628, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Yasin Yurt, Asst. Prof.
Eastern Mediterranean University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 20, 2018
First Posted
May 2, 2018
Study Start
April 15, 2018
Primary Completion
January 15, 2019
Study Completion
January 15, 2019
Last Updated
January 31, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share