A Study to Validate Treadmill Parameters

NCT05333263 | Completed Results FDA Device

• 2 other identifiers: 20-007581W81XWH-20-C-0104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement.

  Treadmill belt displacement (cm) will be measured with a Motion Capture system for each perturbation trial and compared to the commanded magnitude to assess system accuracy. Mean observed treadmill belt displacement, in centimeters, relative to commended treadmill belt displacement was calculated and the mean relative error (percentage) was reported. Percent Error = (Commanded Kinematic Value - Observed Kinematic Value)/Commanded Kinematic Value \*100%. The mean value is then determined from the individual errors for each participant. This results in Mean Relative Error. Lower numbers are considered a better outcome (less error). A negative percentage indicates that the observed value is larger than the command value.

  Duration of participant test session (approximately 2 hours)

• Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity.

  Treadmill belt peak velocity (cm/s) will be measured with a Motion Capture system for each perturbation trial and compared to the commanded magnitude to assess system accuracy. Mean observed treadmill belt peak velocity, in centimeters/second, relative to commended treadmill belt peak velocity was calculated and the mean relative error (percentage) was reported. Percent Error = (Commanded Kinematic Value - Observed Kinematic Value)/Commanded Kinematic Value \*100%. The mean value is then determined from the individual errors for each participant. This results in Mean Relative Error. Lower numbers are considered a better outcome (less error). A negative percentage indicates that the observed value is larger than the command value.

  Duration of participant test session (approximately 2 hours)

• Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration.

  Treadmill belt average initial acceleration (cm/s/s) will be measured with a Motion Capture system for each perturbation trial and compared to the commanded magnitude to assess system accuracy. Mean observed treadmill belt average initial acceleration, in centimeters/second/second, relative to commended treadmill belt average initial acceleration was calculated and the mean relative error (percentage) was reported. Percent Error = (Commanded Kinematic Value - Observed Kinematic Value)/Commanded Kinematic Value \*100%. The mean value is then determined from the individual errors for each participant. This results in Mean Relative Error. Lower numbers are considered a better outcome (less error). A negative percentage indicates that the observed value is larger than the command value.

  Duration of participant test session (approximately 2 hours)

Study Arms (3)

ABB Motor

EXPERIMENTAL

Subjects will undergo a balance assessment using the following program on the treadmill: 3-phase-motor, velocity control mode.

Device: Treadmetrix

ETM Motor

EXPERIMENTAL

Subjects will undergo a balance assessment using the following program on the treadmill: single-phase, velocity control mode.

Device: Treadmetrix

NIDEC/CT Motor

EXPERIMENTAL

Subjects will undergo a balance assessment using the following program on the treadmill: single-phase motor, position-mode.

Device: Treadmetrix

Interventions

Treadmetrix DEVICE

Programmable treadmill that delivers controlled postural disturbances

ABB Motor; ETM Motor; NIDEC/CT Motor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Current or chronic pain in your shoulders, elbows, hips, knees, ankles, feet, neck or back.
• Use of assistive device such as walker or cane.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Results Point of Contact

• Title: Kenton Kaufman, Ph.D
• Organization: Mayo Clinic

Kaufman.Kenton@mayo.edu

507-284-2262

Study Officials

• Kenton Kaufman, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: June 17, 2022
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Locations

US (1)