Adult Spinal Deformity Surgery Real-World Functional Activity

Not Applicable

Recruiting

• Conditions: Degenerative Thoracolumbar Deformity
• Interventions: Device: Triaxial accelerometer

• Registration Number: NCT05611775
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-11-01
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-10
• Study Start: 2023-06-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

° Unable to return to Mayo Clinic for follow-up evaluation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Activity Monitor Assessment	Triaxial accelerometer	Subjects will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester and have activity monitored in the free-living environment.

Primary Outcome Measures

Name	Time	Method
Motion Analysis Lab - Change in trunk stability	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.
Motion Analysis Lab - Change in function	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	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.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States