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Clinical Trials/NCT02237248
NCT02237248
Completed
Not Applicable

Functional Testing, and Biomechanics Before and After Scoliosis Surgery

Duke University1 site in 1 country15 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Idiopathic Scoliosis
Sponsor
Duke University
Enrollment
15
Locations
1
Primary Endpoint
Change in Lower Quarter Y-Balance Test (YBT-LQ)
Status
Completed
Last Updated
8 years ago

Overview

Brief 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).

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
June 19, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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

  • Change in Marx Activity Scale(Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively)
  • Change in Tegner Activity Scale(Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively)
  • Change in EQ-5D(Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively)
  • Change in SRS-22(Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively)

Study Sites (1)

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