Oxygen Consumption in Adolescent Idiopathic Scoliosis

Sponsor

Eastern Mediterranean University (Other)

Overall Status

Completed

CT.gov ID

NCT03514082

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Idiopathic Scoliosis	Device: Rigid Thermoplastic Spinal Brace

Study Design

Study Type:

Observational

Actual Enrollment :

15 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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 :

Apr 15, 2018

Actual Primary Completion Date :

Jan 15, 2019

Actual Study Completion Date :

Jan 15, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eastern Mediterranean University	Mersin	Famagusta	Turkey	99628

Sponsors and Collaborators

Eastern Mediterranean University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasin YURT, Assistant Professor, Eastern Mediterranean University

ClinicalTrials.gov Identifier:

NCT03514082

Other Study ID Numbers:

ETK00-2016-0141

First Posted:

May 2, 2018

Last Update Posted:

Jan 31, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scoliosis

Study Results

No Results Posted as of Jan 31, 2019