NCT02237248

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

2.6 years

First QC Date

September 9, 2014

Last Update Submit

June 27, 2017

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Adolescent Idiopathic ScoliosisFunctional Movement ScreenY Balance Test

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Neuromuscular or congenital scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

  • Robert K Lark, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 11, 2014

Study Start

November 1, 2014

Primary Completion

June 19, 2017

Study Completion

June 19, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

US(1)