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| Name | Class |
|---|---|
| Innovative Design Labs | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Walkasins and PhySens-IMM System--Single Arm | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Walkasins | Device | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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.) | 3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John P Condon, MSEE | Innovative Design Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pillars at Prospect Park | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36204554 | Background | 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. | |
| 31039180 |
| Label | URL |
|---|---|
| Walkasins Provider--RxFunction Company Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Walkasins and PhySens-IMM System--Single Arm | 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 first 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Walkasins and PhySens-IMM System--Single Arm | 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 first 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.) | Posted | Mean | Standard Deviation | Meters/Second | 3 Times During 1 Session <1.5 Hours (Screening + Walkasins Off Condition then Walkasins On Condition) |
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Adverse Events were monitored during the subject visits (lasting approximately 1.5 hours). No adverse events occurred during the study's duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Walkasins and PhySens-IMM System--Single Arm | 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 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. |
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This trial was an exploratory pilot study only, and as such, participants were not randomized. In addition, 75% of the participants were females, and only 12 individuals participated in the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Specialist | RxFunction | 612-358-2141 | Yvonne.Rumsey@rxfunction.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2023 | Apr 13, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 21, 2023 | Apr 14, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition) |
| 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. | Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition) |
| 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. | Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition) |
| 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. | Once During 1 Session <1.5 Hours |
| Background |
| 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. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Saint Louis University Mental Status (SLUMS) Test | The Saint Louis University Mental Status (SLUMS) test is an assessment tool for dementia and mild cognitive impairment. It consists of 11 items with a minimum score of 0 and a maximum score of 30. For those with less than a high school education, scores of 25-30 indicate normal cognition; scores of 20-24 indicate mild neurocognitive disorder; and scores of 1-19 indicate dementia. For those with a high school education, scores of 27-30 indicate normal cognition; scores of 21-26 indicate mild neurocognitive disorder; and scores of 1-20 indicate dementia. | Mean | Standard Deviation | Score on a Scale |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a Scale | Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Seconds | Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Seconds | Twice During 1 Session <1.5 Hours (Walkasins Off Condition then Walkasins On Condition) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a Scale | Once During 1 Session <1.5 Hours |
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| 12 |
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| 12 |
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