Clinical trial NCT05723822: Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments
Official title: A Pilot Study to Explore the Effects of Lower-Leg Mechanical Tactile Sensory Stimulation on the Gait Speed of Mildly Cognitively Impaired Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Cognitive Decline
Gait Disorders in Old Age
Lead sponsor: RxFunction Inc.
Sponsor class: INDUSTRY
Collaborators: name: Innovative Design Labs
First posted: 2023-02-13
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)
timeFrame: 3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
measure: Timed Up and Go (TUG)
timeFrame: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
measure: Timed Up and Go Cognitive (TUG-COG)
timeFrame: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
measure: Falls Efficacy Scale
timeFrame: Once During 1 Session <1.5 Hours
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: The Pillars at Prospect Park
state: Minnesota
Study officials:
affiliation: Innovative Design Labs
name: John P Condon, MSEE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.