A Study to Validate Treadmill Parameters

Healthy Clinical Trial

Official title:

Validation of Treadmill Disturbance Parameters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333263
• Other study ID #: 20-007581
• Secondary ID: W81XWH-20-C-0104
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Treadmetrix
Programmable treadmill that delivers controlled postural disturbances

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: belt displacement.	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.	Duration of participant test session (approximately 2 hours)
Primary	Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: peak velocity.	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.	Duration of participant test session (approximately 2 hours)
Primary	Estimate the limits of agreement between observed and commanded treadmill belt disturbance parameters: average initial acceleration.	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.	Duration of participant test session (approximately 2 hours)
Secondary	Kinetic loading exerted on treadmill during perturbations: treadmill force.	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.	Duration of participant test session (approximately 2 hours)