Overview

This trial is active, not recruiting.

Condition adolescent idiopathic scoliosis
Sponsor Duke University
Start date November 2014
End date June 2017
Trial size 15 participants
Trial identifier NCT02237248, Pro00055257

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Change in Lower Quarter Y-Balance Test (YBT-LQ)
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in Functional Movement Screen (FMS)
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

Secondary Outcomes

Measure
Change in Tegner Activity Scale
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in Marx Activity Scale
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in EQ-5D
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in SRS-22
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

Eligibility Criteria

Female participants from 12 years up to 18 years old.

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

Additional Information

Official title Functional Testing, and Biomechanics Before and After Scoliosis Surgery
Principal investigator Robert K Lark, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Duke University.