N/A
Completed N=12
Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments
Mild Cognitive Impairment · Cognitive Decline · Gait Disorders in Old Age
Source: ClinicalTrials.gov NCT05723822 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Change in 4-Meter Gait Speed (Section 2 of the Short Physical Performance Battery) — 0.79; 0.82; 0.79 Meters/Second
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.
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 | — |
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. Informational only — not medical advice.