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

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Device: Rigid Thermoplastic Spinal Brace

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Turkey
  • Famagusta
    • Mersin, Famagusta, Turkey, 99628
      • Eastern Mediterranean University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject who come to our outpatient clinic will be assessed for eligibility.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Functions	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.	Assessment will be done at the end of first month of conservative treatment.
Balance	Balance will be assessed with a special equipment that gives deviation that lower values mean better.	Assessment will be done at the end of first month of conservative treatment.
Lower extremity loading symmetry	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.	Assessment will be done at the end of first month of conservative treatment.

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Principal Investigator: Yasin Yurt, Asst. Prof., Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: April 20, 2018
• First Submitted That Met QC Criteria: April 20, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: ETK00-2016-0141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No