Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments

A Pilot Study to Explore the Effects of Lower-Leg Mechanical Tactile Sensory Stimulation on the Gait Speed of Mildly Cognitively Impaired Individuals

The primary aim of this pilot study is to investigate the effect of Walkasins, a wearable lower-limb sensory prosthesis, on the gait speed and balance function of participants with mild cognitive impairment as measured by the Saint Louis University Mental Status (SLUMS) Examination.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Cognitive Decline; Gait Disorders in Old Age
• Intervention / Treatment: Device: Walkasins

Detailed Description

The Walkasins system is one of a growing number of wearable devices that use various modalities of neuromodulation, defined as "the alteration of nerve activity through targeted delivery of a stimulus . . . to specific neurological sites in the body" (https://www.neuromodulation.com/). Because these technologies are relatively new, innovative applications of their use in various patient populations may lead to improvements in the care and quality of life of individuals who suffer from these life-altering diagnoses.

Previous studies of Walkasins have shown that individuals with peripheral neuropathy who have gait and balance problems walk faster with the Walkasins device. This increase may be related to an improved automaticity of gait function, which decreases the need for cognitive attention to the walking task, which is known to slow down gait. Individuals with mild cognitive impairment commonly show slow gait speeds, likely due to a decline in executive function. There is a reason to think that sensory stimuli from the Walkasins device can improve the automaticity of gait in these individuals and thereby enhance gait speed.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • The Pillars at Prospect Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ambulatory person who is at least 65 years of age
• Ability to understand and provide informed consent
• Ability to perceive vibrations from the Walkasins Haptic Module
• Ability to complete the functional outcome measures without the use of an assistive device
• Foot size that allows the Walkasins to function appropriately
• Mild Cognitive Impairment (MCI) as measured by the Saint Louis University Mental Status (SLUMS) Exam (scores between 20 and 24 + or -2 for those with less than a high school education and scores between 21-26 + or -2 for those who graduated from high school, which indicate mild cognitive impairment) and/or a diagnosis of MCI (or related term) in the person's medical record
• Slow gait speed (<1m/second or slightly faster, provided all other criteria are met)

Exclusion Criteria:

• Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
• Self-reported acute thrombophlebitis including deep vein thrombosis
• Untreated lymphedema
• Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
• Untreated fractures in the foot and ankle
• Self-reported severe peripheral vascular disease
• Other neurological conditions that impact walking (e.g., peripheral neuropathy)
• Weighs more than 300 pounds

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Walkasins and PhySens-IMM System--Single Arm; Participants who meet the eligibility criteria will don a pair of Walkasins and the PhySens-IMM System. They will perform some brief balance exercises (i.e., sensory integration exercises) and then complete the outcome assessments with their Walkasins turned off and without the use of an assistive device. After a rest period of about five minutes, they will repeat the outcome assessments with their Walkasins turned on.

Device: Walkasins; Walkasins is a non-invasive, wearable, lower limb sensory prosthesis, prescribed by a healthcare professional for long-term daily use as a prosthesis. It directly replaces the part of the function of the sensory end organs that persons with peripheral neuropathy have lost, the sensation in the soles of their feet. The system is comprised of two primary operating components: A Receptor Sole, properly placed in the shoe, detects and transmits plantar pressure information normally performed by the mechanoreceptors and distal axons in the soles of the feet.; A Haptic Module, worn around the lower leg, generates directional specific mechanical tactile stimuli that produce action potentials that signal relevant balance information to the nervous system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)	The 4-meter gait speed test measures the number of seconds it takes a person to walk four meters on a level surface. Gait speed measures are a significant indicator of a person's functional mobility. Higher gait speeds (meters/second) are better than lower gait speeds and are indicative of better functional mobility. (Generally, gait speeds less than 1m/second are considered slow.)	3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls Efficacy Scale	The Falls Efficacy Scale is a 16-item questionnaire that measures an individual's fear of falling or concerns about falling during activities of daily living. Scores may range from 16 (not at all concerned) to 64 (very concerned). Lower scores are better than higher scores because they indicate less concern about falling.	Once During 1 Session <1.5 Hours
Short Physical Performance Battery (SPPB)	The Short Physical Performance Battery measures walking speed, standing balance, and sit-to-stand performance. Scores on balance, gait speed, and chair-stand tests are added (summed) for a total score. (Scores on balance, gait speed, and chair-stand tests are not reported separately since they are not "subscales" per se.) SPPB scores may range from 0 to 12. Higher total scores indicate better balance and gait.	Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
Timed Up and Go (TUG)	The Timed Up and Go Test is part of the Centers for Disease Control (CDC)-recommended STEADI test protocol for balance function. From a seated position in a standard armchair, the participant is asked to stand up from the chair, walk to a line on the floor 10 feet away at normal pace, turn, walk back to the chair at normal pace, and sit down again. The tester records the time taken from the command "Go" until the subject sits down again. Lower times indicate better/faster performance.	Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
Timed Up and Go Cognitive (TUG-COG)	The TUG-COG is performed similarly to the TUG; however, the participant is also asked to count backwards by 3 from a randomly selected number between 20 and 100 while performing the TUG (standing up from the chair, walking to a line on the floor 10 feet away, turning, walking back to the chair at a normal pace, and sitting down again). Lower times indicate better/faster performance.	Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)

Collaborators and Investigators

• Sponsor: RxFunction Inc.
• Collaborators: Innovative Design Labs, Inc.
• Investigators: Principal Investigator: John P Condon, MSEE, Innovative Design Labs, Inc.

Publications and helpful links

General Publications

• Oddsson LIE, Bisson T, Cohen HS, Iloputaife I, Jacobs L, Kung D, Lipsitz LA, Manor B, McCracken P, Rumsey Y, Wrisley DM, Koehler-McNicholas SR. Extended effects of a wearable sensory prosthesis on gait, balance function and falls after 26 weeks of use in persons with peripheral neuropathy and high fall risk-The walk2Wellness trial. Front Aging Neurosci. 2022 Sep 20;14:931048. doi: 10.3389/fnagi.2022.931048. eCollection 2022.
• Koehler-McNicholas SR, Danzl L, Cataldo AY, Oddsson LIE. Neuromodulation to improve gait and balance function using a sensory neuroprosthesis in people who report insensate feet - A randomized control cross-over study. PLoS One. 2019 Apr 30;14(4):e0216212. doi: 10.1371/journal.pone.0216212. eCollection 2019.

Helpful Links

• Walkasins Provider--RxFunction Company Website

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: CIP 0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes