HealthyNCT05333263

A Study to Validate Treadmill Parameters

A study testing Treadmetrix in people with Healthy, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Treadmetrix
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 17 Jun 2022to 17 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Validation of Treadmill Disturbance Parameters

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

Conditions: Healthy
Being tested: Treadmetrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TreadmetrixDevice
Programmable treadmill that delivers controlled postural disturbances

Study groups in NCT05333263
Study group	Role	What they receive
ABB Motor	Experimental	Subjects will undergo a balance assessment using the following program on the treadmill: 3-phase-motor, velocity control mode. Receives: Device: Treadmetrix
ETM Motor	Experimental	Subjects will undergo a balance assessment using the following program on the treadmill: single-phase, velocity control mode. Receives: Device: Treadmetrix
NIDEC/CT Motor	Experimental	Subjects will undergo a balance assessment using the following program on the treadmill: single-phase motor, position-mode. Receives: Device: Treadmetrix

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Duration of participant test session (approximately 2 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jun 202217 Dec 2024

First posted18 Apr 2022
Study start17 Jun 2022
Primary completion17 Dec 2024
Study completion17 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05333263
Sponsor's protocol ID: 20-007581
Other IDs: W81XWH-20-C-0104
Status last verified: Dec 2025
First submitted: 11 Apr 2022
Last updated: 23 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validation of Treadmill Disturbance Parameters
ClinicalTrials.gov ID: NCT05333263
Acronym / sponsor ID: 20-007581
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 17 Jun 2022 (actual)
Primary completion: 17 Dec 2024 (actual)
Study completion: 17 Dec 2024 (actual)
First posted: 18 Apr 2022 (actual)
Results: Posted 23 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ABB Motor	Experimental	Device: TreadmetrixSubjects will undergo a balance assessment using the following program on the treadmill: 3-phase-motor, velocity control mode.
ETM Motor	Experimental	Device: TreadmetrixSubjects will undergo a balance assessment using the following program on the treadmill: single-phase, velocity control mode.
NIDEC/CT Motor	Experimental	Device: TreadmetrixSubjects will undergo a balance assessment using the following program on the treadmill: single-phase motor, position-mode.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TreadmetrixProgrammable treadmill that delivers controlled postural disturbances	Device	ABB Motor, ETM Motor, NIDEC/CT Motor

Primary outcome

Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement.
Time frame: Duration of participant test session (approximately 2 hours)
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.
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity.
Time frame: Duration of participant test session (approximately 2 hours)
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.
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration.
Time frame: Duration of participant test session (approximately 2 hours)
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.

Results and safety

Results posted to the registry on 23 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABB Motor	5	5
ETM Motor	2	2
NIDEC/CT Motor	5	5

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

Time frame: Duration of participant test session (approximately 2 hours). Mean (Standard Deviation). Unit: Mean Relative Error (%)

Measure	ABB Motor n = 5	ETM Motor n = 2	NIDEC/CT Motor n = 5
4 cm	-8.5 (4.2)	20.0 (1.3)	2.1 (1.2)
20 cm	-5.8 (0.5)	-6.6 (0.8)	-0.2 (0.1)
40 cm	-5.9 (0.4)	-7.5 (2.3)	-0.5 (0.1)
60 cm	-6.0 (0.9)	-2.9 (0.7)	-3.1 (2.8)
80 cm	-3.8 (1.4)	9.4 (0.6)	-2.4 (3.9)
-4 cm	-2.8 (2.9)	20.0 (3.0)	2.2 (1.2)
-20 cm	-5.5 (0.3)	-6.9 (2.2)	-0.3 (0.3)
-40 cm	-5.6 (0.4)	-2.6 (6.0)	-0.6 (0.2)

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

Time frame: Duration of participant test session (approximately 2 hours). Mean (Standard Deviation). Unit: Mean Relative Error (%)

Measure	ABB Motor n = 5	ETM Motor n = 2	NIDEC/CT Motor n = 5
20 cm/s	0.1 (0.5)	15.8 (3.2)	-0.9 (0.8)
100 cm/s	-2.9 (0.8)	-2.9 (4.0)	-2.1 (0.9)
200 cm/s	-3.9 (0.5)	-5.8 (2.0)	-2.7 (0.9)
300 cm/s	-3.3 (0.4)	4.3 (2.6)	-1.0 (0.7)
400 cm/s	-2.5 (0.4)	20.4 (1.1)	14.4 (2.0)
-20 cm/s	1.7 (1.6)	15.4 (1.8)	-0.2 (1.4)
-100 cm/s	-1.7 (1.2)	0.8 (1.0)	-1.8 (1.2)
-200 cm/s	-2.5 (0.6)	2.2 (2.5)	-2.3 (1.5)

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

Time frame: Duration of participant test session (approximately 2 hours). Mean (Standard Deviation). Unit: Mean Relative Error (%)

Measure	ABB Motor n = 5	ETM Motor n = 2	NIDEC/CT Motor n = 5
100 cm/s/s	0.2 (7.4)	-6.9 (0.7)	-15.2 (4.7)
500 cm/s/s	1.1 (3.5)	5.8 (1.6)	-1.6 (1.1)
1000 cm/s/s	1.7 (1.5)	5.9 (3.0)	-0.5 (0.9)
1500 cm/s/s	1.8 (0.8)	18.7 (3.0)	2.4 (1.2)
2000 cm/s/s	3.0 (1.2)	37.3 (2.6)	25.3 (3.1)
-100 cm/s/s	-2.8 (6.5)	-7.2 (1.3)	-14.9 (6.4)
-500 cm/s/s	2.6 (1.4)	8.7 (3.6)	-0.4 (1.9)
-1000 cm/s/s	3.4 (0.8)	15.9 (5.2)	0.6 (2.3)

Adverse events

Time frame: Adverse events were collected from the time of informed consent through study completion, approximately 2 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABB Motor	0 of 5 (0%)	0 of 5 (0%)	0 of 5
ETM Motor	0 of 2 (0%)	0 of 2 (0%)	0 of 2
NIDEC/CT Motor	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kenton Kaufman, PhD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Treadmetrix in people with Healthy, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. (time frame: Duration of participant test session (approximately 2 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05333263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.