NCT05723822

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: RxFunction Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-16
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2023-02-13
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study