Oxygen Consumption in Adolescent Idiopathic Scoliosis

Completed

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Device: Rigid Thermoplastic Spinal Brace

• Registration Number: NCT03514082
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-15
• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-04-20
• Study First Posted: 2018-05-02
• Status Verified: 2019-01
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescent Idiopathic Scoliosis	Rigid Thermoplastic Spinal Brace	Subjects with AIS who are beginning to the conservative treatment.

Primary Outcome Measures

Name	Time	Method
Gait Oxygen Consumption	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

Name	Time	Method
Pulmonary Functions	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	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	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.

Trial Locations

Locations (1)

Eastern Mediterranean University; 🇹🇷 Mersin, Famagusta, Turkey