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NCT05364320 Clinical Trial

A Study to Evaluate Spine Motion in Older Adults

Healthy Clinical Trial

— SADLROM  

Official title:
Lumbar Spine Range of Motion and EMG Outcomes in Older Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05364320
Other study ID # 20-013160
Secondary ID K25AG068368
Status Completed
Phase
First received
Last updated
Start date March 10, 2022
Est. completion date March 28, 2023

Study information
Verified date April 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 28, 2023
Est. primary completion date March 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Thoracic and lumbar spine ranges of motions in degrees Day 1
Primary Paraspinal muscle activities in Newtons Day 1
Secondary Upper extremity strength in Newtons Day 1
Secondary Lower extremity strength in Newton-meters Day 1
Secondary Physical activity levels measured by IPAQ questionnaire in MET-minutes per week MET (metabolic equivalent task) is defined as 1 kcal/kg/hour Day 1
Secondary Physical activity levels measured by accelerometry in MET-minutes per week Day 5
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