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| ID | Type | Description | Link |
|---|---|---|---|
| R56AG054797-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Aging (NIA) | NIH |
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The aging population is at an exceptionally high risk of debilitating falls, contributing significantly to reduced independence and quality of life. It remains extremely challenging to screen for falls risk, and programs designed to mitigate falls risk have only modestly influenced the sizeable portion of the aging population experiencing one or more falls annually. Balance control in standing and walking depends on integrating reliable sensory feedback and on planning and executing appropriate motor responses. Walking balance control is especially dynamic, requiring active and coordinated adjustments in posture (i.e., trunk stabilization) and foot placement from step to step. Accordingly, using a custom, immersive virtual environment, the investigators have shown that sensory (i.e., optical flow) perturbations, especially when applied during walking, elicit strong and persistent motor responses to preserve balance. Exciting pilot data suggest that these motor responses are remarkably more prevalent in old age, presumably governed by an increased reliance on vision for balance control. Additional pilot data suggest that prolonged exposure to these perturbations may effectively condition successful balance control strategies. Founded on these recent discoveries, and leveraging the increase reliance on vision for balance control in old age, the investigators stand at the forefront of a potentially transformative new approach for more effectively identifying and mitigating age-related falls risk. The investigator's overarching hypothesis is that optical flow perturbations, particularly when applied during walking, can effectively identify balance deficits due to aging and falls history and can subsequently condition the neuromechanics of successful balance control via training.
Specific Aim 1. Investigate sensory, motor, and cognitive-motor mechanisms governing susceptibility to optical flow perturbations. Aging increases the reliance on vision for balance control. However, central and peripheral mechanisms underlying aging and falls history effects on the susceptibility to optical flow perturbations are unclear. Hypothesis 1: Entrainment to optical flow perturbations will correlate most strongly with visual dependence and decreased somatosensory function, alluding to an age-associated process of multi-sensory reweighting. Methods: Multivariate models will quantify the extent to which strategically-selected sensory (i.e., visual dependence via rod/frame test, somatosensory function), motor (i.e., rate of torque development, timed sit-to-stand) and cognitive-motor (i.e., interference) mechanisms underlie inter-individual differences in susceptibility to perturbations.
Specific Aim 2. Estimate the efficacy of prolonged optical flow perturbations to condition the neuromechanics of walking balance control in older adult fallers. Pilot data from young adults suggests that prolonged exposure to optical flow perturbations may condition reactive strategies used to successfully control walking balance. The investigator's premise is that dynamic perturbation training can improve resilience to unexpected balance disturbances. Here, the investigators conduct a preliminary test of the effects of training with optical flow perturbations on walking balance in older adult fallers. Hypothesis 2: (a) Older adults with a history of falls will adapt to prolonged exposure to perturbations, conditioning their step to step adjustments in walking balance control, and (b) improving their response to unexpected balance challenges following training. Methods: In two 20 min sessions, on different days in a randomized cross-over design, older adults with a history of falls will walk with ("treatment" session) and without ("control" session) prolonged exposure to optical flow perturbations. The investigators will assess time-dependent changes in the neuromechanics of walking balance during training and after-effects via gait variability, dynamic stability, and performance on a series of real-world like targeting and obstacle avoidance tasks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention, then Control | Experimental | Older adults will walk during exposure to optical flow perturbations |
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| Control, then Intervention | Experimental | Older adults will walk normally (without optical flow perturbations) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical flow perturbations | Behavioral | Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality during treadmill walking. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Postural Sway After 10 Min of Walking | Magnitude of side-to-side postural sway | Baseline, 10 minutes |
| Change in Kinematic Variability After 10 Min of Walking | Magnitude of step-to-step corrections in step width measured in cm | Baseline, 10 minutes |
| Change in Foot Placement Targeting Accuracy After 10 Min of Walking | Accuracy of performing foot placement targeting task. i.e., distance between heel marker at initial contact and target line (measured using three-dimensional motion capture during walking). | Baseline, 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive-motor Interference Accuracy After 10 Min of Walking | Accuracy performing an auditory stroop test (cognitive dual-task) | Baseline, 10 minutes |
| Change in Cognitive-motor Interference Response Time After 10 Min of Walking |
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Inclusion Criteria:
OLDER NON-FALLERS
OLDER ADULTS WITH A HISTORY OF FALLS
Age 65+ years
History of one or more falls* in the prior 12 months
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Franz, PhD | Unviersity of North Carolina at Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Biomechanics Laboratory | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25687664 | Result | Franz JR, Francis CA, Allen MS, O'Connor SM, Thelen DG. Advanced age brings a greater reliance on visual feedback to maintain balance during walking. Hum Mov Sci. 2015 Apr;40:381-92. doi: 10.1016/j.humov.2015.01.012. Epub 2015 Feb 14. | |
| 26233581 | Result | Francis CA, Franz JR, O'Connor SM, Thelen DG. Gait variability in healthy old adults is more affected by a visual perturbation than by a cognitive or narrow step placement demand. Gait Posture. 2015 Sep;42(3):380-5. doi: 10.1016/j.gaitpost.2015.07.006. Epub 2015 Jul 17. |
| Label | URL |
|---|---|
| Applied Biomechanics Laboratory | View source |
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There is no plan to share IPD with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention, Then Control | Older adults will first walk during exposure to optical flow perturbations Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality. Normal walking |
| FG001 | Control, Then Intervention | Older adults will first walk normally (without optical flow perturbations) Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality. Normal walking |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Session 1 |
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| Washout (1 Week) |
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| Session 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Older adults will walk during exposure to optical flow perturbations Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality. Normal 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 | Change in Postural Sway After 10 Min of Walking | Magnitude of side-to-side postural sway | Posted | Mean | Standard Deviation | cm | Baseline, 10 minutes |
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From the time of enrollment through the completion of the second 3-hour session approximately 1 week later
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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 | Intervention | Older adults will walk during exposure to optical flow perturbations Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason R Franz, PhD | University of North Caroilina at Chapel Hill | 919-966-6119 | jrfranz@email.unc.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 | Sep 1, 2017 | May 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| D020233 | Gait Disorders, Neurologic |
| D020886 | Somatosensory Disorders |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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In two 20 min sessions, on different days in a randomized cross-over design, older adults will walk with ("treatment" session) and without ("control" session) prolonged exposure to optical flow perturbations.
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No Masking
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| Normal walking | Behavioral | Usual treadmill walking without optical flow perturbations |
|
Response time in performing an auditory stroop test (cognitive dual-task)
| Baseline, 10 minutes |
| Change in Margin of Stability Variability After 10 Min of Walking | Change in step-to-step fluctuations in margin of stability (the distance between the lateral boundary of the foot and the body's center of mass, measured in cm) | Baseline, 10 minutes |
| 28371662 | Result | Thompson JD, Franz JR. Do kinematic metrics of walking balance adapt to perturbed optical flow? Hum Mov Sci. 2017 Aug;54:34-40. doi: 10.1016/j.humov.2017.03.004. Epub 2017 Apr 2. |
| 28400615 | Result | Stokes HE, Thompson JD, Franz JR. The Neuromuscular Origins of Kinematic Variability during Perturbed Walking. Sci Rep. 2017 Apr 11;7(1):808. doi: 10.1038/s41598-017-00942-x. |
| 31262319 | Derived | Richards JT, Selgrade BP, Qiao M, Plummer P, Wikstrom EA, Franz JR. Time-dependent tuning of balance control and aftereffects following optical flow perturbation training in older adults. J Neuroeng Rehabil. 2019 Jul 1;16(1):81. doi: 10.1186/s12984-019-0555-3. |
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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 | Count of Participants | Participants |
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| History of Falls | Self-reported history of at least 1 fall in the prior 12 months. | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Change in Kinematic Variability After 10 Min of Walking | Magnitude of step-to-step corrections in step width measured in cm | Posted | Mean | Standard Deviation | cm | Baseline, 10 minutes |
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|
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| Primary | Change in Foot Placement Targeting Accuracy After 10 Min of Walking | Accuracy of performing foot placement targeting task. i.e., distance between heel marker at initial contact and target line (measured using three-dimensional motion capture during walking). | Data could not be collected because motion capture markers tracking the location of the targeting device were too often obstructed to be able to reliably estimate foot placement targeting accuracy. | Posted | Baseline, 10 minutes |
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| Secondary | Change in Cognitive-motor Interference Accuracy After 10 Min of Walking | Accuracy performing an auditory stroop test (cognitive dual-task) | Data could not be collected because noise from the treadmill motor interfered with the collection of auditory stroop test responses. | Posted | Baseline, 10 minutes |
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| Secondary | Change in Cognitive-motor Interference Response Time After 10 Min of Walking | Response time in performing an auditory stroop test (cognitive dual-task) | Data could not be collected because noise from the treadmill motor interfered with the collection of auditory stroop test responses. | Posted | Baseline, 10 minutes |
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| Secondary | Change in Margin of Stability Variability After 10 Min of Walking | Change in step-to-step fluctuations in margin of stability (the distance between the lateral boundary of the foot and the body's center of mass, measured in cm) | Posted | Mean | Standard Deviation | cm | Baseline, 10 minutes |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Normal Walking (Control) | Older adults will first walk normally (without optical flow perturbations) | 0 | 14 | 0 | 14 | 0 | 14 |
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| D012678 | Sensation Disorders |