Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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, such as electrical stimulation or chemical agents, 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Arm Participants who meet all 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 first with their Walkasins turned off and without the use of an assistive device. After a brief rest period, they will repeat the outcome assessments with their Walkasins turned on. |
Device: Walkasins
The Walkasins System is a prosthetic device that replaces part of the function of the nerves in the feet that are used to detect and inform the brain about foot contact with the ground, which is critical for maintaining balance during standing and walking activities. It provides directional mechanical tactile stimuli to the front, back, left, and right surfaces of the user's legs, relaying balance information to a location above the ankle where skin sensation is still present.
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Outcome Measures
Primary Outcome Measures
- Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery) [3 Times During 1 Session <1.5 Hours (Screening + Walkasins On and Off Conditions)]
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.
Secondary Outcome Measures
- Short Physical Performance Battery (SPPB) [Twice During 1 Session <1.5 Hours]
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 for a total score. 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]
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]
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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ambulatory person who is at least 65 years of age
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Ability to understand and provide informed consent
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Ability to perceive vibrations from the Walkasins Haptic Module
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Ability to complete the functional outcome measures without the use of an assistive device
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Foot size that allows the Walkasins to function appropriately
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Mild Cognitive Impairment as measured by the Saint Louis University Mental Status (SLUMS) Exam (scores between 20 and 24 for those with less than a high school education and scores between 21-26 for those who graduated from high school, which indicate mild cognitive impairment)
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Slow gait speed (<1m/second)
Exclusion Criteria:
- SLUMS scores <20 and >24 for those with less than a high school education and <21 and
26 for those with a high school education
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Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
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Self-reported acute thrombophlebitis including deep vein thrombosis
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Untreated lymphedema
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Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
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Untreated fractures in the foot and ankle
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Self-reported severe peripheral vascular disease
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Other neurological conditions that impact walking (e.g., peripheral neuropathy)
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Weighs more than 300 pounds
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Pillars at Prospect Park | Minneapolis | Minnesota | United States | 55414 |
Sponsors and Collaborators
- RxFunction Inc.
- Innovative Design Labs, Inc.
Investigators
- Principal Investigator: John P Condon, MSEE, Innovative Design Labs, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- CIP 0007