Back to resultsEffects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments
Primary Purpose
Mild Cognitive Impairment, Cognitive Decline, Gait Disorders in Old Age
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walkasins
Sponsored by
About this trial
This is an interventional supportive care trial for Mild Cognitive Impairment
Eligibility Criteria
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
Sites / Locations
- The Pillars at Prospect Park
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Walkasins and PhySens-IMM System--Single Arm
Arm 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.
Outcomes
Primary Outcome Measures
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.)
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05723822
First Posted
February 1, 2023
Last Updated
May 9, 2023
Sponsor
RxFunction Inc.
Collaborators
Innovative Design Labs, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05723822
Brief Title
Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RxFunction Inc.
Collaborators
Innovative Design Labs, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Cognitive Decline, Gait Disorders in Old Age
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walkasins and PhySens-IMM System--Single Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Walkasins
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery)
Description
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.)
Time Frame
3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition)
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
Title
Timed Up and Go Cognitive (TUG-COG)
Description
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.
Time Frame
Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition)
Title
Falls Efficacy Scale
Description
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.
Time Frame
Once During 1 Session <1.5 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Condon, MSEE
Organizational Affiliation
Innovative Design Labs, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pillars at Prospect Park
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36204554
Citation
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.
Results Reference
background
PubMed Identifier
31039180
Citation
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.
Results Reference
background
Links:
URL
https://www.rxfunction.com/
Description
Walkasins Provider--RxFunction Company Website
Learn more about this trial
Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments
We'll reach out to this number within 24 hrs