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| ID | Type | Description | Link |
|---|---|---|---|
| 2P20GM109090-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Recent research on slips has shown that use of perturbation training to improve specific motor skills to resist slips can vastly reduce falls. However, these interventions have only addressed slips occurring at heel-strike, and not the diverse range of slipping disturbances presented by a complex environment. This project will focus on slips that occur across the gait cycle, and the reactive stabilization movements that follow.
Participants from two age groups will be enrolled: younger (19 - 35 years of age) and older (65-79 years of age). Each participant will participate in 3 visits within the span of 1 week. On the initial visit, participants will perform informed consent, have demographic and body measurement information collected and complete medical and physical activity questionnaires. Upper and lower body strength will be measured using a hand-held dynamometer during the first and last visits. On each of the three visits, subjects will perform a gait variability assessment followed by a diverse slip perturbation assessment. Participants will complete four slips in each of early, middle, and late stance on each visit. Measures of falls, slip severity, and reactive stabilization movements will be calculated.
Recent research on slips has shown that use of perturbation training to improve specific motor skills to resist slips can vastly reduce falls. However, these interventions have only addressed slips occurring at heel-strike, and not the diverse range of slipping disturbances presented by a complex environment. This study will focus on slips that occur across the gait cycle, and the reactive stabilization movements that follow. Slips at different phases of the gait cycle have unique biomechanical contexts, and successful reactive stabilization movements are likely to be highly specific to that context. Yet nothing is known about the specificity of the repertoire of reactive stabilization movements to resist different slip conditions. Furthermore, variability in the repertoire of reactive stabilization movements is likely to affect the success/failure rate of resisting these disturbances. Thus, the objective of the proposed study is to determine the roles of variability and specificity in reactive stabilization movements to resist falling in diverse slipping conditions.
A novel wearable apparatus for slipping perturbations (WASP) will deliver lifelike, unexpected slips in early, middle and late stance in younger (19 - 35 years of age) and older adults. Biomechanical analysis based on three-dimensional motion capture data of the reactive stabilization movements will generate novel results on the specificity and variability of protective stepping and arm swinging responses. The central hypothesis is that increases in specificity and decreases in variability of reactive stabilization movements will reduce fall rates. The long-term objective of this research is to support future studies into the repertoire of reactive stabilization movements across the full range of disturbances faced in navigating the environment.
Each participant will participate in 3 visits within the span of 1 week. On the initial visit, participants will perform informed consent, have demographic and body measurement information collected and complete medical and physical activity questionnaires. Upper and lower body strength will be measured using a hand-held dynamometer during the first and last visits. On each of the three visits, subjects will perform a gait variability assessment followed by a diverse slip perturbation assessment. Before recording data, retroreflective markers will be placed on specific anatomical locations. These locations are defined to create a full-body dynamics model. For gait variability assessment, participants will be familiarized with the activity, then they will walk on a treadmill for 5 minutes at a prescribed pace of 1.3 meters per second while whole body kinematics are collected. Both linear and nonlinear measures of gait variability will be calculated to determine possible relationships between these measures and other outcome variables such as learning rate for reactive movements and fall rate.
For diverse slip perturbation assessment, participants will walk overground back and forth across a large motion capture area. Previous studies show that walking speed is highly correlated with some outcome measures, specifically variations in whole body angular momentum, gait variability measures, and loss of balance following a slip. Therefore, gait speed will be controlled to 1.3 ± 0.2 m/s, a typically comfortable speed for both younger and older adults. Participants will be informed that a slip may occur, and that if slipped, they should attempt to maintain balance and continue walking. Participants will then be slipped without warning at a randomly chosen time after 1 to 3 minutes of walking. Slips will be administered to both feet simultaneously during early, middle or late stance in a randomized order. After each slip, participants will rest seated for 5 minutes. During this rest period, motion capture data and force data from the harness will be recorded, and the WASP will be reset for the next trial. Participants will complete four slips in each of early, middle, and late stance on each visit. Measures of falls, slip severity, and reactive stabilization movements will be calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slipping Perturbations | Experimental | Participants will be exposed to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administered Slip Perturbations | Other | Participants will be exposed to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Fall Rates | Percentage of trials which result in a fall. Falls are classified when the maximum force on the load cell in the harness system exceeds 30% body weight. | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Heel Displacement of the Slipping Foot Following Slip Perturbation | The total displacement of the slipping foot from the point of administered slip perturbation, until the foot stops sliding is assessed. | Up to 7 days |
| Trunk Angular Momentum Following 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 |
|---|---|---|---|---|---|---|
| University of Nebraska-Omaha, Biomechanics Research Building | Omaha | Nebraska | 68182 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Slipping Perturbations - Younger Adults | The intervention involves exposing younger adult participants to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase. Administered Slip Perturbations: Slips will be administered in early, middle or late phases of stance during overground walking. |
| FG001 | Slipping Perturbations - Older Adults | The intervention involves exposing older adult participants to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase. Administered Slip Perturbations: Slips will be administered in early, middle or late phases of stance during overground walking. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Slipping Perturbations - Younger Adults | The intervention involves exposing younger adult participants to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase. Administered Slip Perturbations: Slips will be administered in early, middle or late phases of stance during overground walking. |
| 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 | Percentage of trials which result in a fall. Falls are classified when the maximum force on the load cell in the harness system exceeds 30% body weight. | Participants were administered slips 12 times in a session for each of 3 sessions. | Posted | Number | Percentage of trials resulting in falls. | Up to 7 days | Trials | Trials |
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Up to 7 days
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 | Slipping Perturbations - Younger Adults | The intervention involves exposing younger adult participants to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase. Administered Slip Perturbations: Slips will be administered in early, middle or late phases of stance during overground walking. |
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Fall rates were derived from controlled walking trials using a safety harness on a sliding gantry. The harness may have influenced natural recovery responses. Additionally, laboratory conditions and participants' awareness of slip risk could have induced anticipatory behaviors, limiting generalizability.
| 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 | Apr 20, 2021 | Apr 8, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2023 | Apr 8, 2025 | ICF_001.pdf |
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Angular momentum of the trunk is assessed during the period of time from the onset of slip perturbation until the subject recovers or falls. |
| Up to 7 days |
| Position of the Recovery Step Following Slip Perturbation | Position of the placement of the swing foot relative to the center of mass in the transverse plane following slip perturbation will be assessed. | Up to 7 days |
| Coefficient of Variation of Stride Time Time Series | The coefficient of variation of the time series of stride times during treadmill walking is assessed. | Up to 7 days |
| Maximum Heel Sliding Velocity of the Slipping Foot Following Slip Perturbation | The maximum velocity of the slipping foot will be assessed within the period from the administered slip perturbation, until the foot stops sliding. | Up to 7 days |
| Time of the Recovery Step Following Slip Perturbation | Time of the placement of the swing foot relative to the onset of the administered slip perturbation is assessed | Up to 7 days |
| Sample Entropy of Stride Time Time Series | The sample entropy of the time series of stride times during treadmill walking is assessed. | Up to 7 days |
| BG001 | Slipping Perturbations - Older Adults | The intervention involves exposing older adult participants to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase. Administered Slip Perturbations: Slips will be administered in early, middle or late phases of stance during overground walking. |
| 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 |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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| Slipping Perturbations - Older Adults |
The intervention involves exposing older adult participants to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase. Administered Slip Perturbations: Slips will be administered in early, middle or late phases of stance during overground walking. |
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| Secondary | Total Heel Displacement of the Slipping Foot Following Slip Perturbation | The total displacement of the slipping foot from the point of administered slip perturbation, until the foot stops sliding is assessed. | Not Posted | Dec 2026 | Up to 7 days | Participants |
| Secondary | Trunk Angular Momentum Following Slip Perturbation | Angular momentum of the trunk is assessed during the period of time from the onset of slip perturbation until the subject recovers or falls. | Not Posted | Dec 2026 | Up to 7 days | Participants |
| Secondary | Position of the Recovery Step Following Slip Perturbation | Position of the placement of the swing foot relative to the center of mass in the transverse plane following slip perturbation will be assessed. | Not Posted | Dec 2026 | Up to 7 days | Participants |
| Secondary | Coefficient of Variation of Stride Time Time Series | The coefficient of variation of the time series of stride times during treadmill walking is assessed. | Not Posted | Dec 2026 | Up to 7 days | Participants |
| Secondary | Maximum Heel Sliding Velocity of the Slipping Foot Following Slip Perturbation | The maximum velocity of the slipping foot will be assessed within the period from the administered slip perturbation, until the foot stops sliding. | Not Posted | Dec 2026 | Up to 7 days | Participants |
| Secondary | Time of the Recovery Step Following Slip Perturbation | Time of the placement of the swing foot relative to the onset of the administered slip perturbation is assessed | Not Posted | Dec 2026 | Up to 7 days | Participants |
| Secondary | Sample Entropy of Stride Time Time Series | The sample entropy of the time series of stride times during treadmill walking is assessed. | Not Posted | Dec 2026 | Up to 7 days | Participants |
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| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Slipping Perturbations - Older Adults | The intervention involves exposing older adult participants to a series of 12 unannounced slip perturbations while walking overground. These perturbations will be delivered at 3 different times within the gait cycle - early phase, middle phase, and late phase. Administered Slip Perturbations: Slips will be administered in early, middle or late phases of stance during overground walking. | 0 | 22 | 0 | 22 | 0 | 22 |
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