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Mild Cognitive ImpairmentNCT05723822

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

A study testing Walkasins in people with Mild Cognitive Impairment and Cognitive Decline, run by RxFunction Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Walkasins
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
16 Feb 2023to 31 Mar 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • The Pillars at Prospect Park

    Minneapolis, Minnesota, 55414

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Walkasins
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WalkasinsDevice

    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.
Study groups in NCT05723822
Study groupRoleWhat they receive
Walkasins and PhySens-IMM System--Single ArmExperimentalParticipants 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.
Receives: Device: Walkasins

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)

    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.)

    Measured: 3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)

Secondary outcomes (4)

  1. Short Physical Performance Battery (SPPB)

    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.

    Measured: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)

  2. Timed Up and Go (TUG)

    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.

    Measured: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)

  3. Timed Up and Go Cognitive (TUG-COG)

    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.

    Measured: Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)

  4. Falls Efficacy Scale

    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.

    Measured: Once During 1 Session <1.5 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2023
  2. Study start16 Feb 2023
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05723822
Sponsor's protocol ID
CIP 0007
Status last verified
May 2023
First submitted
1 Feb 2023
Last updated
5 Jun 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36204554

  • 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.

    PubMed 31039180

Questions about this trial

What is this clinical trial studying?

A study testing Walkasins in people with Mild Cognitive Impairment and Cognitive Decline, run by RxFunction Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery) (time frame: 3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05723822, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.

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