The Sensorimotor Locus of Balance Control in Elderly Gait
2 other identifiers
interventional
14
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2017
CompletedFirst Submitted
Initial submission to the registry
October 31, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2018
CompletedResults Posted
Study results publicly available
July 5, 2019
CompletedJuly 5, 2019
February 1, 2019
9 months
October 31, 2017
May 10, 2019
June 27, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (3)
Change in Cognitive-motor Interference Accuracy After 10 Min of Walking
Baseline, 10 minutes
Change in Cognitive-motor Interference Response Time After 10 Min of Walking
Baseline, 10 minutes
Change in Margin of Stability Variability After 10 Min of Walking
Baseline, 10 minutes
Study Arms (2)
Intervention, then Control
EXPERIMENTALOlder adults will walk during exposure to optical flow perturbations
Control, then Intervention
EXPERIMENTALOlder adults will walk normally (without optical flow perturbations)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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"
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Applied Biomechanics Laboratory
Chapel Hill, North Carolina, 27514, United States
Related Publications (5)
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.
PMID: 25687664RESULTFrancis 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.
PMID: 26233581RESULTThompson 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.
PMID: 28371662RESULTStokes 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.
PMID: 28400615RESULTRichards 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.
PMID: 31262319DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jason R Franz, PhD
- Organization
- University of North Caroilina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Franz, PhD
Unviersity of North Carolina at Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No Masking
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2017
First Posted
November 14, 2017
Study Start
October 30, 2017
Primary Completion
July 25, 2018
Study Completion
July 25, 2018
Last Updated
July 5, 2019
Results First Posted
July 5, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share IPD with other researchers.