- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341728
The Sensorimotor Locus of Balance Control in Elderly Gait
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Applied Biomechanics Laboratory
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be able to walk without an assistive aid (i.e., walker, cane)
- Have the full capacity to provide informed consent
OLDER NON-FALLERS
- Age 65+ years
- No history of falls* in the prior 12 months
OLDER ADULTS WITH A HISTORY OF FALLS
- Age 65+ years
History of one or more falls* in the prior 12 months
- For the purposes of this study, falls counted towards the self-reported total will be defined as per the Kellogg International Work Group - a fall is "unintentionally coming to the ground or some lower level and other than as a consequence of sustaining a violent blow, loss of consciousness, sudden onset of paralysis as in stroke or an epileptic seizure"
Exclusion Criteria:
- Current lower extremity injury or fracture
- Taking medication that causes dizziness
- Have a leg prosthesis
- Prisoners
- Individuals clearly lacking the capacity to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention, then Control
Older adults will walk during exposure to optical flow perturbations
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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.
Usual treadmill walking without optical flow perturbations
|
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EXPERIMENTAL: Control, then Intervention
Older adults will walk normally (without 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 during treadmill walking.
Usual treadmill walking without optical flow perturbations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Postural Sway After 10 Min of Walking
Time Frame: Baseline, 10 minutes
|
Magnitude of side-to-side postural sway
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Baseline, 10 minutes
|
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Change in Kinematic Variability After 10 Min of Walking
Time Frame: Baseline, 10 minutes
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Magnitude of step-to-step corrections in step width measured in cm
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Baseline, 10 minutes
|
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Change in Foot Placement Targeting Accuracy After 10 Min of Walking
Time Frame: Baseline, 10 minutes
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Cognitive-motor Interference Accuracy After 10 Min of Walking
Time Frame: Baseline, 10 minutes
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Accuracy performing an auditory stroop test (cognitive dual-task)
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Baseline, 10 minutes
|
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Change in Cognitive-motor Interference Response Time After 10 Min of Walking
Time Frame: Baseline, 10 minutes
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Response time in performing an auditory stroop test (cognitive dual-task)
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Baseline, 10 minutes
|
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Change in Margin of Stability Variability After 10 Min of Walking
Time Frame: Baseline, 10 minutes
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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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jason Franz, PhD, Unviersity of North Carolina at Chapel Hill
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-2267
- R56AG054797-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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