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Completed

NCT Number: NCT02237248

Function and Scoliosis Surgery

The purpose of the study is to examine the changes in function and performance biomechanics in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis (AIS).

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Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

12 year–18 year

Sex eligibility

Female

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

About this study

Methods will consist of movement studies, questionnaires, and chart review. The recruited subjects will be followed at the usual clinical schedule of pre-op, 6-week, 3 -, 6- and 12-month post-operative follow-up visits. After signing informed consent, age at time of surgery, height, weight, body composition, leg length will be recorded to be used during data processing. Chart review will further yield data on Cobb angle, Lenke Scoliosis classification, instrumentation used during surgery, and level of spinal fusion. All subjects will be asked to complete assessments of activity level (Marx Score, Tegner Activity Score), general health (EQ-5D), and a validated scoliosis survey (Scoliosis Research Study questionnaire SRS-22). Movement studies will consist of the Lower Quarter Y Balance Test (YBT-LQ), and Functional Movement Screen (FMS), and measures of forward flexion, right and left lateral bending, and right and left trunk rotation. These measures will be assessed preoperatively and at postoperative follow-up visits.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of idiopathic scoliosis
  • Patients identified to undergo spinal fusion surgery
  • Treated at Duke University Medical Center

Exclusion criteria

  • Neuromuscular or congenital scoliosis

Treatment and study plan

Primary outcomes

  1. Change in Lower Quarter Y-Balance Test (YBT-LQ)

    Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

    The YBT-LQ is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.

  2. Change in Functional Movement Screen (FMS)

    Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

    The FMS is a screening tool used to identify limitations or asymmetries in movement patterns by executing seven motions. Activities include a deep squat, lunges, hurdle steps, a push-up, straight-leg raises, shoulder mobility assessments, and rotary stability assessments.

Secondary outcomes

  1. Change in Tegner Activity Scale

    Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

  2. Change in Marx Activity Scale

    Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

  3. Change in EQ-5D

    Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

  4. Change in SRS-22

    Time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Functional Testing, and Biomechanics Before and After Scoliosis Surgery

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2014
Registry last updated
Jun 28, 2017

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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