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Variable Visual Stimulus as a Novel Approach for Gait Rehabilitation (VISNA)

Primary Purpose

Gait Disorders, Neurologic

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fractal visual cueing
Periodic visual cueing
Random visual cueing
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait Disorders, Neurologic focused on measuring Visual, Variability, Gait, Fractals, Rehabilitation, Brain

Eligibility Criteria

65 Years - 90 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Be able to provide informed consent.
  • Be able to walk independently without an assistive device.
  • Not suffer from neurological disease.
  • Not suffer from any lower limb disabilities, injuries or disease.

Exclusion Criteria:

  • If diagnosed with a pathology that directly affects the musculoskeletal system such as rheumatoid arthritis, neuropathy or myopathy, vertigo, joint replacement, diabetes, stroke or other vascular problems, scoliosis, uncorrected vision problems,major surgery in the last 6 months, or acute illness.
  • Any neurologic conditions or lower limb disabilities or disease.
  • History of seizures, migraines or headaches, or are visually impaired.
  • Subjects unable to walk unassisted or unable to perform 10 minutes of continuous walking.

Sites / Locations

  • University of Nebraska at Omaha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Sham Comparator

No Intervention

Arm Label

Fractal visual cueing

Periodic visual cueing

Random visual cueing

Control

Arm Description

This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be fractal (i.e., pink noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom.

This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be periodic (i.e., invariant). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom.

This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be random (i.e., white noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom.

Natural walking.

Outcomes

Primary Outcome Measures

Stride length
Meters
Stride time
Seconds
Stride speed
Meters/seconds
Cortical hemodynamics
Micromoles

Secondary Outcome Measures

Joint angles
Radians
Peak torque of knee extensor muscles at 60º/s
Newton-meters

Full Information

First Posted
November 7, 2018
Last Updated
August 24, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT03737331
Brief Title
Variable Visual Stimulus as a Novel Approach for Gait Rehabilitation
Acronym
VISNA
Official Title
Variable Visual Stimulus as a Novel Approach for Gait Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Canceled
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Deterioration in walking performance as a result of disease or simply as a result of aging is a serious threat to independence in older adults. In this project, the investigators propose an innovative visual stimulus, based on advanced mathematical and biological theories, with which older adults can walk in time to improve their walking. The investigators' goal is to apply this simple, cost-effective, and novel gait rehabilitation therapy across all populations who have difficulties walking, e.g. stroke patients, fallers or those who undergo joint replacement.
Detailed Description
Walking synchronized to a visual stimulus is commonly used for gait rehabilitation, and has been shown to alter gait parameters such as stride length and stride time in a variety of patient populations. Typically, the patient is instructed to walk by stepping on lines or other markers placed on the ground presented in a fixed, invariant distance with each other. Whilst improvements in gait parameters have been observed in these experimental conditions, the investigators submit that a fundamentally different approach could lead to much greater benefits. The investigators' laboratory has successfully shown that walking to an invariant stimulus, with no variability, runs contrary to the natural stride-to-stride fluctuations (i.e., gait variability) that are known to exist in human gait. The investigators propose that the elimination of variability from gait, as is the case when walking with invariant external cueing, will not provide the movement abilities needed by individuals with reduced mobility to navigate the real world, unpredictable environments. In this project, the investigators propose an alternative approach to rehabilitation of gait disorders with respect to external cueing that takes the natural variability of healthy gait into account. The investigators have previously shown that young and older adults when walking to an invariant stimulus, display diminished natural stride-to-stride fluctuations. Preliminary data has also shown that the natural stride-to-stride fluctuations that exist in healthy gait are altered with aging, but can also be restored to levels similar to young adults when walking to a Variable Visual Stimulus. The investigators proposed solution is then to transform the standard invariant visual cueing paradigm by using a Variable Visual Stimulus that reflects the variable movement patterns found in healthy gait. This is because the presentation of our Stimulus will be variable, but it will not be random. There will be a pattern contained within the presentation of our Stimulus that is based upon the patterns found in healthy young adults. This project will investigate the long-term effects of viewing an invariant, a random and a variable visual stimulus on gait variability in older adults. Furthermore, the investigators will investigate the retention effects at 1- and 3-months of an 8-week program. The central hypothesis is that older adults who are at risk of falling will demonstrate greater improvements in gait variability and adaptive gait tasks when walking with a Variable Visual Stimulus that reflects the variable movement patterns found in healthy gait. The impact of this project will be transformational regarding gait rehabilitation for older adults who are at risk of falls. This simple, cost-effective method would be accessible to all gait rehabilitation clinics requiring only ubiquitously available glasses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorders, Neurologic
Keywords
Visual, Variability, Gait, Fractals, Rehabilitation, Brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Older adults at risk of a fall will participate in an 8-week training program. There will be four groups: no stimulus (i.e., control), invariant, random and variable stimuli. The training program will consist in an 8-week program, 3 sessions per week. For each training session, participants will come to the Biomechanics Research Building for a 30-minute training session (2 x 10-minute walking trials with a 10-minute resting period in between), 3 times per week. During the training session, the subjects will be instructed to walk while viewing and synchronizing the steps with the visual stimulus. In the first session of weeks 3, 5 and 7, the subjects will undergo a reassessment of the preferred stride time, wearing the footswitches. This reassessment will be needed to recalculate the preferred stride time and incorporate it in the stimulus in use, in case it has been changed as an effect of the training.
Masking
Participant
Masking Description
Participants will be randomly assigned with a block randomization design for one of the four groups: no stimulus (i.e. control), invariant, random and variable stimuli. Subjects will be assigned to unique ID code such as 'S00NC', where S means subject, 00N refers to participant number (i.e., 001 or 100), and C the group condition (N - No stimulus; P - Periodic stimulus; V - Variant stimulus; R - Random stimulus).
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractal visual cueing
Arm Type
Experimental
Arm Description
This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be fractal (i.e., pink noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom.
Arm Title
Periodic visual cueing
Arm Type
Active Comparator
Arm Description
This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be periodic (i.e., invariant). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom.
Arm Title
Random visual cueing
Arm Type
Sham Comparator
Arm Description
This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be random (i.e., white noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Natural walking.
Intervention Type
Behavioral
Intervention Name(s)
Fractal visual cueing
Intervention Description
Walking to an external visual fractal (i.e., pink noise) stimulus.
Intervention Type
Behavioral
Intervention Name(s)
Periodic visual cueing
Intervention Description
Walking to an external visual periodic (i.e., invariant) stimulus.
Intervention Type
Behavioral
Intervention Name(s)
Random visual cueing
Intervention Description
Walking to an external visual random (i.e., white noise) stimulus.
Primary Outcome Measure Information:
Title
Stride length
Description
Meters
Time Frame
Through study completion, an average of 1 year
Title
Stride time
Description
Seconds
Time Frame
Through study completion, an average of 1 year
Title
Stride speed
Description
Meters/seconds
Time Frame
Through study completion, an average of 1 year
Title
Cortical hemodynamics
Description
Micromoles
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Joint angles
Description
Radians
Time Frame
Through study completion, an average of 1 year
Title
Peak torque of knee extensor muscles at 60º/s
Description
Newton-meters
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be able to provide informed consent. Be able to walk independently without an assistive device. Not suffer from neurological disease. Not suffer from any lower limb disabilities, injuries or disease. Exclusion Criteria: If diagnosed with a pathology that directly affects the musculoskeletal system such as rheumatoid arthritis, neuropathy or myopathy, vertigo, joint replacement, diabetes, stroke or other vascular problems, scoliosis, uncorrected vision problems,major surgery in the last 6 months, or acute illness. Any neurologic conditions or lower limb disabilities or disease. History of seizures, migraines or headaches, or are visually impaired. Subjects unable to walk unassisted or unable to perform 10 minutes of continuous walking.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis M Silva, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska at Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68182
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21802756
Citation
Stergiou N, Decker LM. Human movement variability, nonlinear dynamics, and pathology: is there a connection? Hum Mov Sci. 2011 Oct;30(5):869-88. doi: 10.1016/j.humov.2011.06.002. Epub 2011 Jul 29.
Results Reference
background
PubMed Identifier
22314273
Citation
Brach JS, Wert D, VanSwearingen JM, Newman AB, Studenski SA. Use of stance time variability for predicting mobility disability in community-dwelling older persons: a prospective study. J Geriatr Phys Ther. 2012 Jul-Sep;35(3):112-7. doi: 10.1519/JPT.0b013e318243e5f9.
Results Reference
background
PubMed Identifier
17632004
Citation
Brach JS, Studenski S, Perera S, VanSwearingen JM, Newman AB. Stance time and step width variability have unique contributing impairments in older persons. Gait Posture. 2008 Apr;27(3):431-9. doi: 10.1016/j.gaitpost.2007.05.016. Epub 2007 Jul 13.
Results Reference
background
PubMed Identifier
25448244
Citation
Brach JS, Lowry K, Perera S, Hornyak V, Wert D, Studenski SA, VanSwearingen JM. Improving motor control in walking: a randomized clinical trial in older adults with subclinical walking difficulty. Arch Phys Med Rehabil. 2015 Mar;96(3):388-94. doi: 10.1016/j.apmr.2014.10.018. Epub 2014 Nov 10.
Results Reference
background
Links:
URL
https://link.springer.com/content/pdf/10.1007%2Fs10439-012-0654-9.pdf
Description
Kaipust JP, McGrath D, Mukherjee M, Stergiou N. Gait variability is altered in older adults when listening to auditory stimuli with differing temporal structures. Ann Biomed Eng. 2013;41(8):1595-1603. doi:10.1007/s10439-012-0654-9.

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Variable Visual Stimulus as a Novel Approach for Gait Rehabilitation

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