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OpenTrials
Completed

NCT Number: NCT05364320

A Study to Evaluate Spine Motion in Older Adults

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.

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Key information

Conditions

Healthy

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Thoracic and lumbar spine ranges of motions in degrees

    Time frame: Day 1

  2. Paraspinal muscle activities in Newtons

    Time frame: Day 1

Secondary outcomes

  1. Upper extremity strength in Newtons

    Time frame: Day 1

  2. Lower extremity strength in Newton-meters

    Time frame: Day 1

  3. Physical activity levels measured by IPAQ questionnaire in MET-minutes per week

    Time frame: Day 1

    MET (metabolic equivalent task) is defined as 1 kcal/kg/hour

  4. Physical activity levels measured by accelerometry in MET-minutes per week

    Time frame: Day 5

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Lumbar Spine Range of Motion and EMG Outcomes in Older Adults

Acronym: SADLROM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 6, 2022
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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