A Study to Evaluate Spine Motion in Older Adults

Completed

• Conditions: Healthy

• Registration Number: NCT05364320
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is being done to measure real-world motions and forces in the spine during everyday activities. This information will be used to develop and validate a computer model of how the spine moves and determine injury risk.

Detailed Description

Kinematic motion data will be collected at 120 Hz using a 14-camera Real Time Motion Analysis system. Cortex software (Motion Analysis Corp., Rohnert Park, CA) will be used to visualize the data during physical activities. A developed Matlab code will be used for data analysis. Statistical parametric mapping (SPM) will be used to collect the entire kinematic motion waveforms to compare motion profiles of different individuals. Also, the peak values for each activity will be captured for statistical analysis. Muscle response and electrical activity, which will be used to estimate muscle forces, will be recorded during gait analysis from the paraspinal lumbar muscles using an EMG system. Surface electrodes will be attached to the lumbar spine. EMG data will be collected at 2400 Hz. For each participant, the investigators will record five trials per activity.

Additionally, gait speed as well as static and dynamic balance will assess. Knee and grip strength will also be measured. Finally, physical activity levels will be assessed both objectively and subjectively.

Study Timeline

• Study Start: 2022-03-10
• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Primary Completion: 2023-03-24
• Study Completion: 2023-03-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 50 and over
• Ability to perform trunk flexion, lateral bending, and axial rotation, as well as lift at least 5 pounds of weight from the floor

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Exclusion Criteria

• Spinal pathologies
• Physiological and neuromuscular disorders
• BMI>35
• Knee or hip replacement in the past 12 months
• Use of assistive devices
• Frailty: with FRAIL score of 3 or greater

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thoracic and lumbar spine ranges of motions in degrees	Day 1
Paraspinal muscle activities in Newtons	Day 1

Secondary Outcome Measures

Name	Time	Method
Physical activity levels measured by accelerometry in MET-minutes per week	Day 5
Upper extremity strength in Newtons	Day 1
Lower extremity strength in Newton-meters	Day 1
Physical activity levels measured by IPAQ questionnaire in MET-minutes per week	Day 1	MET (metabolic equivalent task) is defined as 1 kcal/kg/hour

Trial Locations

Locations (1)

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