Function and Scoliosis Surgery

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Functional Testing, and Biomechanics Before and After Scoliosis Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237248
• Other study ID #: Pro00055257
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: June 27, 2017
• Start date: November 2014
• Est. completion date: June 19, 2017

Study information

• Verified date: June 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 19, 2017
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Tegner Activity Scale		Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Secondary	Change in Marx Activity Scale		Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Secondary	Change in EQ-5D		Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Secondary	Change in SRS-22		Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively