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

NCT05723822 | Completed Results FDA Device

• 1 other identifier: CIP 0007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Cognitive Decline; Gait Disorders in Old Age

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Short Physical Performance Battery (SPPB)

  Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)

• Timed Up and Go (TUG)

  Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)

• Timed Up and Go Cognitive (TUG-COG)

  Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)

• Falls Efficacy Scale

  Once During 1 Session <1.5 Hours

Study Arms (1)

Walkasins and PhySens-IMM System--Single Arm

EXPERIMENTAL

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

Interventions

Walkasins DEVICE

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.

Walkasins and PhySens-IMM System--Single Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• RxFunction Inc.: lead
• Innovative Design Labs: collaborator

Study Sites (1)

The Pillars at Prospect Park

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (2)

• 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.

  PMID: 36204554 BACKGROUND

• 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.

  PMID: 31039180 BACKGROUND

Related Links

• Walkasins Provider--RxFunction Company Website

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

This trial was an exploratory pilot study only, and as such, participants were not randomized. In addition, 75% of the participants were females, and only 12 individuals participated in the study.

Results Point of Contact

• Title: Clinical Research Specialist
• Organization: RxFunction

Yvonne.Rumsey@rxfunction.com

612-358-2141

Study Officials

• John P Condon, MSEE

  Innovative Design Labs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 13, 2023
• Study Start: February 16, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 5, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)