CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Walkasinsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05723822
NCT05723822N/ACompleted

A Pilot Study to Explore the Effects of Lower-Leg Mechanical Tactile Sensory Stimulation on the Gait Speed of Mildly Cognitively Impaired Individuals

RxFunction Inc.·interventional·Posted Feb 13, 2023·Updated Jun 5, 2023

In Brief

A clinical study evaluating Walkasins for Mild Cognitive Impairment and 2 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedFeb 13, 2023
Enrollment StartFeb 16, 2023
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.4 years ago

Interventions

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.