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

RxFunction

Status: Completed

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

Treatments: Device: Walkasins

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05723822

CIP 0007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Walkasins and PhySens-IMM System--Single Arm

Experimental group

Description:

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.

Treatment:

Device: Walkasins