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Completed

NCT Number: NCT03514082

Oxygen Consumption in Adolescent 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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Mediterranean University

Mersin, Famagusta, 99628, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rigid Thermoplastic Spinal Brace

Device

Custom made rigid thermoplastic brace with 23 hours daily wearing time.

Primary outcomes

  1. Gait Oxygen Consumption

    Time frame: 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 outcomes

  1. Pulmonary Functions

    Time frame: 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.

  2. Balance

    Time frame: 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.

  3. Lower extremity loading symmetry

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 2, 2018
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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