Real-World Functional Activity in Adult Spinal Deformity Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Motion Analysis Lab - Change in function
Study Overview
Brief Summary
The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of degenerative thoracolumbar deformity
- •Deformity correction surgery scheduled with either Dr. Elder or Dr. Fogelson, minimum 4-level fusion with fixation to the pelvis.
Exclusion Criteria
- •° Unable to return to Mayo Clinic for follow-up evaluation
Arms & Interventions
Activity Monitor Assessment
Subjects will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester and have activity monitored in the free-living environment.
Intervention: Triaxial accelerometer (Device)
Outcomes
Primary Outcomes
Motion Analysis Lab - Change in function
Time Frame: Baseline, 6-12 weeks post-surgery, 1 year
Spatiotemporal measures including velocity, step/stride length, step width, single/double support times, and R/L temporal symmetriesm will be used to measure function.
Motion Analysis Lab - Change in gait
Time Frame: Baseline, 6-12 weeks post-surgery, 1 year
Gait will be measured by segmental and joint range of motion, peak kinetics during walking, and changes in deviation from normal bands using sensory processing measures.
Motion Analysis Lab - Change in trunk stability
Time Frame: Baseline, 6-12 weeks post-surgery, 1 year
Trunk stability will be measured by EMG frequency content and activation pattern during gait and postural sway.
Secondary Outcomes
No secondary outcomes reported
Investigators
Benjamin D. Elder
Principal Investigator
Mayo Clinic