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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-20-C-0104 | Other Grant/Funding Number | Department of Defense |
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The purpose of this study is to evaluate the accuracy with which a microprocessor-controlled treadmill delivers controlled postural disturbances.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABB Motor | Experimental | Subjects will undergo a balance assessment using the following program on the treadmill: 3-phase-motor, velocity control mode. |
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| ETM Motor | Experimental | Subjects will undergo a balance assessment using the following program on the treadmill: single-phase, velocity control mode. |
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| NIDEC/CT Motor | Experimental | Subjects will undergo a balance assessment using the following program on the treadmill: single-phase motor, position-mode. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadmetrix | Device | Programmable treadmill that delivers controlled postural disturbances |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenton Kaufman, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABB Motor | 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 |
| BG001 | ETM Motor |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Mean Relative Error (%) | Duration of participant test session (approximately 2 hours) |
|
Adverse events were collected from the time of informed consent through study completion, approximately 2 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABB Motor | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenton Kaufman, Ph.D | Mayo Clinic | 507-284-2262 | Kaufman.Kenton@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 23, 2020 | Dec 19, 2025 | Prot_001.pdf |
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| Duration of participant test session (approximately 2 hours) |
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 |
| BG002 | NIDEC/CT Motor | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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
| OG001 | 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 |
| OG002 | 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 |
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| Primary | 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. | Posted | Mean | Standard Deviation | Mean Relative Error (%) | Duration of participant test session (approximately 2 hours) |
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| Primary | 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. | Posted | Mean | Standard Deviation | Mean Relative Error (%) | Duration of participant test session (approximately 2 hours) |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | 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 | 0 | 5 | 0 | 5 | 0 | 5 |
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| 200 cm/s |
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| 300 cm/s |
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| 400 cm/s |
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| -20 cm/s |
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| -100 cm/s |
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| -200 cm/s |
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| -300 cm/s |
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| -400 cm/s |
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| 1000 cm/s/s |
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| 1500 cm/s/s |
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| 2000 cm/s/s |
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| -100 cm/s/s |
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| -500 cm/s/s |
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| -1000 cm/s/s |
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| -1500 cm/s/s |
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| -2000 cm/s/s |
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