NCT03341728

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 31, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

October 31, 2017

Results QC Date

May 10, 2019

Last Update Submit

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

EXPERIMENTAL

Older adults will walk during exposure to optical flow perturbations

Behavioral: Optical flow perturbationsBehavioral: Normal walking

Control, then Intervention

EXPERIMENTAL

Older adults will walk normally (without optical flow perturbations)

Behavioral: Optical flow perturbationsBehavioral: Normal walking

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.

Control, then InterventionIntervention, then Control
Normal walkingBEHAVIORAL

Usual treadmill walking without optical flow perturbations

Control, then InterventionIntervention, then Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

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.

  • 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.

Related Links

MeSH Terms

Conditions

Mobility LimitationGait Disorders, NeurologicSomatosensory Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsNervous System DiseasesSensation Disorders

Results Point of Contact

Title
Jason R Franz, PhD
Organization
University of North Caroilina at Chapel Hill

Study Officials

  • Jason Franz, PhD

    Unviersity of North Carolina at Chapel Hill

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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.

Locations