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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03514082
Other study ID # ETK00-2016-0141
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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