Effect of Adult Spinal Deformity Surgery on Functional Reach
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
Adult spinal deformity (ASD) is a common spinal condition that often impacts an individual's ability to stand and maintain an upright posture. Poor balance often limits an individual's ability to perform basic activities of daily life (ADL) and can lead to disability. Current considerations of correcting ASD to improve balance focus on the amount of sway that one exhibits during normal standing. However, current tests do not provide insight into the limits of balance during normal ADL.
The goal of this research is to develop a new balance assessment that includes a functional reach test (FRT) to provide numerical data on the limits of one's ability to maintain balance. The study will include both ASD patients and matched healthy adults and will compare postural sway measures between them. Wearable motion tracking sensors and a force plate will be used to monitor body movement and changes in the center of pressure under foot during normal standing and during a FRT. Data from this study will inform spine surgeons of ASD patient's risk of balance loss in daily life and enable further research on the effects of surgical techniques to restore balance among ASD surgery patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults over the age of 18
Diagnosed with adult spinal deformity according to the SRS-Schwab Adult Spinal Deformity Classification System
Indicated for deformity corrective surgery including multilevel spinal fusion of three or more levels
Lowest instrumented level includes S1 or pelvic fixation
Disqualifiers
Indicated for spinal fusion due to spinal tumor, trauma, or infection
ASD patients who do not plan to be available for all follow-up evaluations at our institution
Pregnancy during any time point within the participation duration
Adults over the age of 18
Trial population
The adult spinal deformity (ASD) group will consist of adults with a diagnosis of scoliosis who are eligible for spinal deformity correcting surgery at the University of Kansas Medical Center. The asymptomatic control group will consist of adults who do not have any spinal diagnoses, have not have prior spinal fusions, and do not have any other conditions that affect their ability to perform the study activities.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Spinal Fusion
Procedure/SurgeryRealignment and fusion of adult spinal deformity
No intervention
Other interventionNo intervention for control group.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Adult spinal deformity surgery patients1 intervention
Group B: Asymptomatic adult controls1 intervention
Trial outcomes
Primary outcomes
1
Functional reach distance
The distance a participant can reach forward (in cm), to the side, and 45 degrees to the side with each arm
Time frame
Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups2
Center of pressure sway range
The range (in mm) that the participant's center of pressure moves in sagittal and coronal plane directions during the functional reach tests
Time frame
Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups3
Center of pressure velocity
The maximum and average velocity (in m/s) that the participant's center of pressure reaches during the functional reach tests
Time frame
Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups4
Center of pressure excursion
The summation of the distance (in mm) that the participant's center of pressure moves during the functional reach tests
Time frame
Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-upsSecondary outcomes
1
Patient reported pain level
Questionnaires assessing level of pain (0-10 on the numeric rating scale) for the mid-back, low-back, and both legs
Time frame
Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups2
Patient reported disability
A questionnaire called the Oswestry disability index (ODI) that assesses level of disability in performing activities of daily living
Time frame
Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups3
Timed up and go test
The time is takes to rise from a chair, walked forward 10 feet, turn around, and then sit back down
Time frame
Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-upsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
Scoliosis Research Society
Collaborator
Source ClinicalTrials.gov