Back to resultsAdult Spinal Deformity Surgery Real-World Functional Activity
Primary Purpose
Degenerative Thoracolumbar Deformity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triaxial accelerometer
Sponsored by
About this trial
This is an interventional supportive care trial for Degenerative Thoracolumbar Deformity
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic MinnesotaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Activity Monitor Assessment
Arm Description
Subjects will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester and have activity monitored in the free-living environment.
Outcomes
Primary Outcome Measures
Motion Analysis Lab - Change in function
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
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
Trunk stability will be measured by EMG frequency content and activation pattern during gait and postural sway.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05611775
Brief Title
Adult Spinal Deformity Surgery Real-World Functional Activity
Official Title
Real-World Functional Activity in Adult Spinal Deformity Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Thoracolumbar Deformity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Activity Monitor Assessment
Arm Type
Other
Arm Description
Subjects will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester and have activity monitored in the free-living environment.
Intervention Type
Device
Intervention Name(s)
Triaxial accelerometer
Intervention Description
Monitors placed on the waist, thigh, and bilateral ankles. Accelerometry will measure patients' physical activities in the free-living environment for 4 consecutive days. The patients will wear the monitor during waking hours and remove it during sleeping, showering, and swimming time.
Primary Outcome Measure Information:
Title
Motion Analysis Lab - Change in function
Description
Spatiotemporal measures including velocity, step/stride length, step width, single/double support times, and R/L temporal symmetriesm will be used to measure function.
Time Frame
Baseline, 6-12 weeks post-surgery, 1 year
Title
Motion Analysis Lab - Change in gait
Description
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.
Time Frame
Baseline, 6-12 weeks post-surgery, 1 year
Title
Motion Analysis Lab - Change in trunk stability
Description
Trunk stability will be measured by EMG frequency content and activation pattern during gait and postural sway.
Time Frame
Baseline, 6-12 weeks post-surgery, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Ranfranz
Phone
507-293-7354
Email
Ranfranz.Rebecca@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Elder, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Adult Spinal Deformity Surgery Real-World Functional Activity
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