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A Study to Validate Treadmill Parameters

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05333263
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
5.5
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the accuracy with which a microprocessor-controlled treadmill delivers controlled postural disturbances.

Condition or Disease Intervention/Treatment Phase
  • Device: Treadmetrix
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Validation of Treadmill Disturbance Parameters
Actual Study Start Date :
Jun 17, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Balance assessment on specialized treadmill

Subjects will undergo a balance assessment on a microprocessor-controlled treadmill

Device: Treadmetrix
Programmable treadmill that delivers controlled postural disturbances

Outcome Measures

Primary Outcome Measures

  1. Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: belt displacement. [Duration of participant test session (approximately 2 hours)]

    Treadmill belt displacement (m) will be measured with a Motion Capture system for each perturbation trial and compared to the commanded magnitude to assess system accuracy.

  2. Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: peak velocity. [Duration of participant test session (approximately 2 hours)]

    Treadmill belt peak velocity (m/s) will be measured with a Motion Capture system for each perturbation trial and compared to the commanded magnitude to assess system accuracy.

  3. Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: average initial acceleration. [Duration of participant test session (approximately 2 hours)]

    Treadmill belt average initial acceleration (m/s/s) will be measured with a Motion Capture system for each perturbation trial and compared to the commanded magnitude to assess system accuracy.

Secondary Outcome Measures

  1. Kinetic loading exerted on treadmill during perturbations: treadmill force. [Duration of participant test session (approximately 2 hours)]

    Treadmill force (N) time series will be measured with force plates imbedded in the treadmill deck and recorded for each perturbation trial to assess the mechanical loading condition on the machine.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy adults with no medical conditions or previous injuries, trauma, or surgeries that reduce your balance, mobility or strength.

  • Able to follow simple directions.

  • Willingness to participate in the study.

  • No restriction will be placed on gender, race, or ethnicity.

Exclusion Criteria:

  • Current or chronic pain in your shoulders, elbows, hips, knees, ankles, feet, neck or back.

  • Use of assistive device such as walker or cane.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Kenton Kaufman, PhD, M

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Kenton R. Kaufman, PhD, PE, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05333263
Other Study ID Numbers:
  • 20-007581
  • W81XWH-20-C-0104
First Posted:
Apr 18, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Jun 30, 2022