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

Not Applicable

Completed

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

Interventions: Device: Walkasins

Registration Number: NCT05723822

Lead Sponsor: RxFunction Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 12

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Walkasins and PhySens-IMM System--Single Arm	Walkasins	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.

Primary Outcome Measures

Name	Time	Method
Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)	3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)	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.)

Secondary Outcome Measures

Name	Time	Method
Short Physical Performance Battery (SPPB)	Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)	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.
Timed Up and Go (TUG)	Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)	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.
Timed Up and Go Cognitive (TUG-COG)	Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)	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.
Falls Efficacy Scale	Once During 1 Session <1.5 Hours	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.