Oxygen Consumption in Adolescent Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Effect of Conservative Treatment on Pulmonary Functions, Gait Oxygen Consumption Balance and Lower Limb Load Distribution in Adolescents With Idiopathic Scoliosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514082
• Other study ID #: ETK00-2016-0141
• Status: Completed
• Start date: April 15, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: January 2019
• Source: Eastern Mediterranean University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• Rigid Thermoplastic Spinal Brace
Custom made rigid thermoplastic brace with 23 hours daily wearing time.

Locations

Country	Name	City	State
Turkey	Eastern Mediterranean University	Mersin	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.