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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15AG063106 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Falls are the leading source of injury for all ages, and for older adults are the primary cause of injury related death. Loss of foot to ground traction accounts for 25-40% of falls, typically referred to as a slip. Slips alter the relationship between center of mass and lower limb base of support resulting in altered whole-body angular momentum and inability to support body weight due to loss of stability. But not all slips lead to falls. Stability may be recovered through a combination of response movements, such as swinging the arms or rapid recovery steps. Stability must be recovered quickly otherwise insufficient bodyweight support rapidly leads to a damaging ground collision. A high percentage of falls result in fractures, contusions and sprains to both the trunk and limbs, while slips disproportionately cause lower back injuries. A primary goal of fall prevention training is to improve the ability to resist slips using perturbations that mimic the specific sensory and biomechanical context of natural slip events. However, generating lifelike slip perturbations that mimic the diversity of slipping conditions poses a significant hurdle to improving a more general slip resistance ability. Using movement analysis, the investigators will determine the relationships between diverse slip conditions, reactive responses to slips from those conditions, and slip vulnerability across the gait cycle to generate new data that may guide future interventions.
Recent evidence suggests most slip-related falls in daily life happen in diverse slipping conditions where the ground is not level, or the person is turning or changing direction. While slips that occur during straight walking on level ground and the responses to those slips are relatively well understood, very little is known about slips that occur while walking on slopes or curved paths and which reactive responses are effective to prevent falls in such conditions. This limits the ability of clinicians to incorporate a diverse range of slipping experiences into fall prevention interventions. Understanding how reactive responses and slip vulnerability depend on diverse slip conditions may guide future interventions that promote a more general fall resistance to the broader range of slips encountered in the real environment.
This project will determine the impact of turns and slopes on reactive movements and fall vulnerability by determining the effects of path curvature on reactive movements and slip vulnerability at different times in the gait cycle and determining the effects of ground slope on reactive movements and slip vulnerability at difference times in the gait cycle. It is hypothesized that diverse slipping conditions will change the reactive responses involving protective stepping and arm swing and that the distinct dynamics of turns and slopes produce maximum vulnerability to slips at different times in the gait cycle compared to slips during straight walking on level ground. To evaluate these aims, the investigators will administer slip perturbations on slopes that vary in both magnitude and direction, on curved paths that vary in curvature, and with slip onset that varies across early, middle, and late stance. Understanding the relationships between diverse slipping conditions, reactive responses, slip severity and fall vulnerability may guide future research and training interventions towards more comprehensive fall resistance ability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slips on Turns | Experimental | Slips will be administered during walking on a curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot. |
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| Slips on Slopes | Experimental | Slips will be administered during walking on sloped ground of 5.0 or 10.0 degrees mediolaterally or anteroposteriorly, or flat ground, in early middle or late stance. For mediolateral slopes, slips will be administered to the uphill or downhill foot. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slips on Turns | Other | A slip will be administered to participants at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips will be delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters. |
| Measure | Description | Time Frame |
|---|---|---|
| Fall Rates - Slips on Turns | Percentage of trials which result in a fall is recorded. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight. | Up to 4 hours |
| Fall Rates - Slips on Slopes | Percentage of trials which result in a fall is recorded. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight. | Up to 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Slipping Foot Distance | The distance travelled by the slipping foot relative to the center of mass following the administered slip perturbation | Up to 4 hours |
| Slipping Foot Maximum Velocity | The maximum velocity of the slipping foot relative to the center of mass following the administered slip perturbation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel H Hunt, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomechanics Research Building | Omaha | Nebraska | 68182 | United States |
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion.
Data access requests should be emailed to the PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Slips on Turns | Slips administered during walking on a straight path, or on curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot. Slips on Turns: Subjects were administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips were delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters. |
| FG001 | Slips on Slopes | Slips administered during walking on sloped ground of 5.0 or 10.0 degrees mediolaterally or anteroposteriorly, or flat ground, in early middle or late stance. For mediolateral slopes, slips were administered to the uphill or downhill foot. Slips on Slopes: Slips were administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the Computer Assisted Rehabilitation Environment (CAREN) system treadmill. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Slips on Turns | Slips administered during walking on a straight path, or on curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot. Slips on Turns: Subjects were administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips were delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters. |
| 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 | Fall Rates - Slips on Turns | Percentage of trials which result in a fall is recorded. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight. | Subjects were administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips were delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters. | Posted | Number | Percent of trials resulting in falls. | Up to 4 hours | Trials | Trials |
|
Up to 4 hours
This protocol was not expected to put participants at risk for Serious Adverse Events, or at risk for All-Cause Mortality.
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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 | Slips on Turns | Slips administered during walking on a straight path, or on curved paths of radii 1.0, or 2.0 meters in early, middle or late stance to the inside or outside foot. Slips on Turns: Subjects were administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips were delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters. |
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Fall rates for slipping on slopes are taken from walking trials on a treadmill. The moving treadmill belts require the participants to recover from the slip and continue walking. Therefore, the fall rates we measured are very likely to overestimate the fall rates from slips on slopes during walking overground.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathaniel Hunt | University of Nebraska Omaha | 402-554-4195 | nhunt@unomaha.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2021 | Apr 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 10, 2023 | Mar 11, 2024 | ICF_001.pdf |
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| Slips on Slopes | Other | Slips will be administered to participants at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the Computer Assisted Rehabilitation Environment (CAREN) system treadmill. |
|
| Up to 4 hours |
| Trunk Maximum Angular Momentum | The maximum angular momentum of the trunk following the administered slip perturbation | Up to 4 hours |
| Reactive Stepping Response Placement | Position of the placement of the reactive stepping response relative to the center of mass following the administered slip perturbation | Up to 4 hours |
| Reactive Stepping Response Time | Duration of time between the onset of the administered slip perturbation and the placement of the reactive stepping response | Up to 4 hours |
| Reactive Arm Swing Momentum Change | The change in arm momentum between the onset of the administered slip perturbation and the end of the slip | Up to 4 hours |
| BG001 | Slips on Slopes | Slips administered during walking on sloped ground of 5.0 or 10.0 degrees mediolaterally or anteroposteriorly, or flat ground, in early middle or late stance. For mediolateral slopes, slips were administered to the uphill or downhill foot. Slips on Slopes: Slips were administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the CAREN system treadmill. |
| BG002 | 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 |
|
| Height | Mean | Standard Deviation | meters |
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| Weight | Mean | Standard Deviation | kilograms |
|
|
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| Primary | Fall Rates - Slips on Slopes | Percentage of trials which result in a fall is recorded. Falls are classified when a load cell embedded in the harness system measures support forces exceeding 30% body weight. | Slips were administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the CAREN system treadmill. | Posted | Number | Percent of trials resulting in falls. | Up to 4 hours | Trials | Trials |
|
|
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| Secondary | Slipping Foot Distance | The distance travelled by the slipping foot relative to the center of mass following the administered slip perturbation | Not Posted | Dec 2026 | Up to 4 hours | Participants |
| Secondary | Slipping Foot Maximum Velocity | The maximum velocity of the slipping foot relative to the center of mass following the administered slip perturbation | Not Posted | Dec 2026 | Up to 4 hours | Participants |
| Secondary | Trunk Maximum Angular Momentum | The maximum angular momentum of the trunk following the administered slip perturbation | Not Posted | Dec 2026 | Up to 4 hours | Participants |
| Secondary | Reactive Stepping Response Placement | Position of the placement of the reactive stepping response relative to the center of mass following the administered slip perturbation | Not Posted | Dec 2026 | Up to 4 hours | Participants |
| Secondary | Reactive Stepping Response Time | Duration of time between the onset of the administered slip perturbation and the placement of the reactive stepping response | Not Posted | Dec 2026 | Up to 4 hours | Participants |
| Secondary | Reactive Arm Swing Momentum Change | The change in arm momentum between the onset of the administered slip perturbation and the end of the slip | Not Posted | Dec 2026 | Up to 4 hours | Participants |
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Slips on Slopes | Slips administered during walking on sloped ground of 5.0 or 10.0 degrees mediolaterally or anteroposteriorly, or flat ground, in early middle or late stance. For mediolateral slopes, slips were administered to the uphill or downhill foot. Slips on Slopes: Slips were administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the CAREN system treadmill. | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Measurements |
|---|---|
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| Fall Rate, Sloped Walking (5 degrees), Downhill Slope |
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| Fall Rate, Sloped Walking (10 degrees), Downhill Slope |
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| Fall Rate, Sloped Walking (5 degrees), Cross-Slope |
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| Fall Rate, Sloped Walking (10 degrees), Cross-Slope |
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