N/A
N=12
Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments
Mild Cognitive Impairment · Cognitive Decline · Gait Disorders in Old Age
Bottom Line
View on ClinicalTrials.gov: NCT05723822 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery) — 0.79; 0.82; 0.79 Meters/Second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Walkasins (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- RxFunction Inc.
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery) |
0.79; 0.82; 0.79 | — |
| SECONDARY Short Physical Performance Battery (SPPB) |
8.2; 7.5 | — |
| SECONDARY Timed Up and Go (TUG) |
15.46; 15.83 | — |
| SECONDARY Timed Up and Go Cognitive (TUG-COG) |
21.64; 18.85 | — |
| SECONDARY Falls Efficacy Scale |
32.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05723822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.