Function and Scoliosis Surgery

Functional Testing, and Biomechanics Before and After 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).

Study Overview

• Status: Completed
• Conditions: Adolescent Idiopathic Scoliosis

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients that are undergoing spinal fusion surgery to treat idiopathic scoliosis.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Lower Quarter Y-Balance Test (YBT-LQ)	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.	Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in Functional Movement Screen (FMS)	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.	Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Tegner Activity Scale	Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Change in Marx 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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Robert K Lark, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): June 19, 2017
• Study Completion (Actual): June 19, 2017

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Functional Movement Screen; Adolescent Idiopathic Scoliosis; Y Balance Test
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: Pro00055257