Trial Outcomes & Findings for A Study to Validate Treadmill Parameters (NCT NCT05333263)

Last Updated: 2025-12-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Duration of participant test session (approximately 2 hours)

Results posted on

2025-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	ABB Motor Subjects underwent a balance assessment using the following program on the treadmill: 3-phase motor, velocity-control mode. Treadmetrix: Programmable treadmill that delivers controlled postural disturbances	ETM Motor Subjects will undergo a balance assessment using the following program on the treadmill: single-phase, velocity control mode. Device: Treadmetrix Programmable treadmill that delivers controlled postural disturbances	NIDEC/CT Motor Subjects will undergo a balance assessment using the following program on the treadmill: single-phase motor, position-mode. Device: Treadmetrix Programmable treadmill that delivers controlled postural disturbances
Overall Study STARTED	5	2	5
Overall Study COMPLETED	5	2	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Validate Treadmill Parameters

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Duration of participant test session (approximately 2 hours)

Outcome measures

Outcome measures
Measure	NIDEC/CT Motor n=5 Participants Subjects will undergo a balance assessment using the following program on the treadmill: single-phase motor, position-mode. Device: Treadmetrix Programmable treadmill that delivers controlled postural disturbances	ABB Motor n=5 Participants Subjects will undergo a balance assessment using the following program on the treadmill: 3-phase-motor, velocity control mode. Treadmetrix: Programmable treadmill that delivers controlled postural disturbances	ETM Motor n=2 Participants Subjects will undergo a balance assessment using the following program on the treadmill: single-phase, velocity control mode. Device: Treadmetrix Programmable treadmill that delivers controlled postural disturbances
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. 4 cm	2.1 Mean Relative Error (%) Standard Deviation 1.2	-8.5 Mean Relative Error (%) Standard Deviation 4.2	20.0 Mean Relative Error (%) Standard Deviation 1.3
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. 20 cm	-0.2 Mean Relative Error (%) Standard Deviation 0.1	-5.8 Mean Relative Error (%) Standard Deviation 0.5	-6.6 Mean Relative Error (%) Standard Deviation 0.8
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. 40 cm	-0.5 Mean Relative Error (%) Standard Deviation 0.1	-5.9 Mean Relative Error (%) Standard Deviation 0.4	-7.5 Mean Relative Error (%) Standard Deviation 2.3
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. 60 cm	-3.1 Mean Relative Error (%) Standard Deviation 2.8	-6.0 Mean Relative Error (%) Standard Deviation 0.9	-2.9 Mean Relative Error (%) Standard Deviation 0.7
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. 80 cm	-2.4 Mean Relative Error (%) Standard Deviation 3.9	-3.8 Mean Relative Error (%) Standard Deviation 1.4	9.4 Mean Relative Error (%) Standard Deviation 0.6
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. -4 cm	2.2 Mean Relative Error (%) Standard Deviation 1.2	-2.8 Mean Relative Error (%) Standard Deviation 2.9	20.0 Mean Relative Error (%) Standard Deviation 3.0
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. -20 cm	-0.3 Mean Relative Error (%) Standard Deviation 0.3	-5.5 Mean Relative Error (%) Standard Deviation 0.3	-6.9 Mean Relative Error (%) Standard Deviation 2.2
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. -40 cm	-0.6 Mean Relative Error (%) Standard Deviation 0.2	-5.6 Mean Relative Error (%) Standard Deviation 0.4	-2.6 Mean Relative Error (%) Standard Deviation 6.0
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. -60 cm	-0.8 Mean Relative Error (%) Standard Deviation 0.5	-5.0 Mean Relative Error (%) Standard Deviation 0.4	5.1 Mean Relative Error (%) Standard Deviation 2.8
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Belt Displacement. -80 cm	3.1 Mean Relative Error (%) Standard Deviation 1.1	-2.0 Mean Relative Error (%) Standard Deviation 2.8	16.8 Mean Relative Error (%) Standard Deviation 3.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NIDEC/CT Motor n=5 Participants Subjects will undergo a balance assessment using the following program on the treadmill: single-phase motor, position-mode. Device: Treadmetrix Programmable treadmill that delivers controlled postural disturbances	ABB Motor n=5 Participants Subjects will undergo a balance assessment using the following program on the treadmill: 3-phase-motor, velocity control mode. Treadmetrix: Programmable treadmill that delivers controlled postural disturbances	ETM Motor n=2 Participants Subjects will undergo a balance assessment using the following program on the treadmill: single-phase, velocity control mode. Device: Treadmetrix Programmable treadmill that delivers controlled postural disturbances
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. 20 cm/s	-0.9 Mean Relative Error (%) Standard Deviation 0.8	0.1 Mean Relative Error (%) Standard Deviation 0.5	15.8 Mean Relative Error (%) Standard Deviation 3.2
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. 100 cm/s	-2.1 Mean Relative Error (%) Standard Deviation 0.9	-2.9 Mean Relative Error (%) Standard Deviation 0.8	-2.9 Mean Relative Error (%) Standard Deviation 4.0
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. 200 cm/s	-2.7 Mean Relative Error (%) Standard Deviation 0.9	-3.9 Mean Relative Error (%) Standard Deviation 0.5	-5.8 Mean Relative Error (%) Standard Deviation 2.0
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. 300 cm/s	-1.0 Mean Relative Error (%) Standard Deviation 0.7	-3.3 Mean Relative Error (%) Standard Deviation 0.4	4.3 Mean Relative Error (%) Standard Deviation 2.6
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. 400 cm/s	14.4 Mean Relative Error (%) Standard Deviation 2.0	-2.5 Mean Relative Error (%) Standard Deviation 0.4	20.4 Mean Relative Error (%) Standard Deviation 1.1
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. -20 cm/s	-0.2 Mean Relative Error (%) Standard Deviation 1.4	1.7 Mean Relative Error (%) Standard Deviation 1.6	15.4 Mean Relative Error (%) Standard Deviation 1.8
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. -100 cm/s	-1.8 Mean Relative Error (%) Standard Deviation 1.2	-1.7 Mean Relative Error (%) Standard Deviation 1.2	0.8 Mean Relative Error (%) Standard Deviation 1.0
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. -200 cm/s	-2.3 Mean Relative Error (%) Standard Deviation 1.5	-2.5 Mean Relative Error (%) Standard Deviation 0.6	2.2 Mean Relative Error (%) Standard Deviation 2.5
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. -300 cm/s	0.1 Mean Relative Error (%) Standard Deviation 1.0	-2.7 Mean Relative Error (%) Standard Deviation 0.6	11.6 Mean Relative Error (%) Standard Deviation 0.2
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Peak Velocity. -400 cm/s	17.3 Mean Relative Error (%) Standard Deviation 2.3	-0.8 Mean Relative Error (%) Standard Deviation 1.1	27.2 Mean Relative Error (%) Standard Deviation 0.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NIDEC/CT Motor n=5 Participants Subjects will undergo a balance assessment using the following program on the treadmill: single-phase motor, position-mode. Device: Treadmetrix Programmable treadmill that delivers controlled postural disturbances	ABB Motor n=5 Participants Subjects will undergo a balance assessment using the following program on the treadmill: 3-phase-motor, velocity control mode. Treadmetrix: Programmable treadmill that delivers controlled postural disturbances	ETM Motor n=2 Participants Subjects will undergo a balance assessment using the following program on the treadmill: single-phase, velocity control mode. Device: Treadmetrix Programmable treadmill that delivers controlled postural disturbances
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. -100 cm/s/s	-14.9 Mean Relative Error (%) Standard Deviation 6.4	-2.8 Mean Relative Error (%) Standard Deviation 6.5	-7.2 Mean Relative Error (%) Standard Deviation 1.3
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. 100 cm/s/s	-15.2 Mean Relative Error (%) Standard Deviation 4.7	0.2 Mean Relative Error (%) Standard Deviation 7.4	-6.9 Mean Relative Error (%) Standard Deviation 0.7
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. 500 cm/s/s	-1.6 Mean Relative Error (%) Standard Deviation 1.1	1.1 Mean Relative Error (%) Standard Deviation 3.5	5.8 Mean Relative Error (%) Standard Deviation 1.6
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. 1000 cm/s/s	-0.5 Mean Relative Error (%) Standard Deviation 0.9	1.7 Mean Relative Error (%) Standard Deviation 1.5	5.9 Mean Relative Error (%) Standard Deviation 3.0
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. 1500 cm/s/s	2.4 Mean Relative Error (%) Standard Deviation 1.2	1.8 Mean Relative Error (%) Standard Deviation 0.8	18.7 Mean Relative Error (%) Standard Deviation 3.0
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. 2000 cm/s/s	25.3 Mean Relative Error (%) Standard Deviation 3.1	3.0 Mean Relative Error (%) Standard Deviation 1.2	37.3 Mean Relative Error (%) Standard Deviation 2.6
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. -500 cm/s/s	-0.4 Mean Relative Error (%) Standard Deviation 1.9	2.6 Mean Relative Error (%) Standard Deviation 1.4	8.7 Mean Relative Error (%) Standard Deviation 3.6
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. -1000 cm/s/s	0.6 Mean Relative Error (%) Standard Deviation 2.3	3.4 Mean Relative Error (%) Standard Deviation 0.8	15.9 Mean Relative Error (%) Standard Deviation 5.2
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. -1500 cm/s/s	4.6 Mean Relative Error (%) Standard Deviation 1.9	2.4 Mean Relative Error (%) Standard Deviation 0.5	29.8 Mean Relative Error (%) Standard Deviation 1.0
Estimate the Limits of Agreement Between Observed and Commanded Treadmill Belt Disturbance Parameters: Average Initial Acceleration. -2000 cm/s/s	28.0 Mean Relative Error (%) Standard Deviation 3.5	5.9 Mean Relative Error (%) Standard Deviation 2.2	45.8 Mean Relative Error (%) Standard Deviation 0.1

Adverse Events

ABB Motor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ETM Motor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NIDEC/CT Motor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kenton Kaufman, Ph.D

Mayo Clinic

Phone: 507-284-2262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	ETM Motor n=2 Participants Subjects will undergo a balance assessment using the following program on the treadmill: single-phase, velocity control mode. Treadmetrix: Programmable treadmill that delivers controlled postural disturbances	NIDEC/CT Motor n=5 Participants Subjects will undergo a balance assessment using the following program on the treadmill: single-phase motor, position-mode. Treadmetrix: Programmable treadmill that delivers controlled postural disturbances	Total n=12 Participants Total of all reporting groups	ABB Motor n=5 Participants Subjects will undergo a balance assessment using the following program on the treadmill: 3-phase-motor, velocity control mode. Treadmetrix: Programmable treadmill that delivers controlled postural disturbances
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=4 Participants	5 Participants n=219 Participants	12 Participants n=219 Participants	5 Participants n=68 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Sex: Female, Male Female	1 Participants n=4 Participants	2 Participants n=219 Participants	4 Participants n=219 Participants	1 Participants n=68 Participants
Sex: Female, Male Male	1 Participants n=4 Participants	3 Participants n=219 Participants	8 Participants n=219 Participants	4 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=4 Participants	5 Participants n=219 Participants	12 Participants n=219 Participants	5 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Race (NIH/OMB) White	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=4 Participants	5 Participants n=219 Participants	12 Participants n=219 Participants	5 Participants n=68 Participants
Region of Enrollment United States	2 participants n=4 Participants	5 participants n=219 Participants	12 participants n=219 Participants	5 participants n=68 Participants