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Wearable Device

Walkasins for Sensory Disorders

N/A
Waitlist Available
Research Sponsored by RxFunction Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 6, week 10 (primary endpoint), week 26, and week 52
Awards & highlights

Summary

This trial investigates the effects of using Walkasins®, a wearable device that helps people with peripheral neuropathy improve their balance by providing sensory feedback to their feet. The study aims to see if this device can lead to sustained improvements in walking and quality of life. The Walkasins® device has shown potential in improving gait and balance dysfunction in patients with peripheral neuropathy.

Eligible Conditions
  • Sensory Disorders
  • Peripheral Neuropathy
  • Vestibular Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 6, week 10 (primary endpoint), week 26, and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2, week 6, week 10 (primary endpoint), week 26, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Functional Gait Assessment
Secondary outcome measures
10-Meter Walk Test
Activities-specific Balance Confidence (ABC) Scale
Falls
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Single Arm Long-Term Follow-upExperimental Treatment1 Intervention
During the baseline visit, participants were randomized to two groups that applied to the first visit only. After the baseline visit, community-dwelling participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52, during which they repeated the functional measures while wearing their Walkasins and responded to the questionnaires. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, device usage, and device functioning. Note: Due to COVID-19 disruptions, some participants were not able to return for all in-person follow-up visits. They completed the patient-reported outcome measures via telephone visits.
Group II: Baseline Group B--Walkasins Off Then OnExperimental Treatment1 Intervention
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on. After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
Group III: Baseline Group A--Walkasins On Then OffExperimental Treatment1 Intervention
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off. After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Walkasins
2018
N/A
~90

Find a Location

Who is running the clinical trial?

RxFunction Inc.Lead Sponsor
2 Previous Clinical Trials
43 Total Patients Enrolled
Lars Oddsson, PhDStudy DirectorRxFunction Inc.
~10 spots leftby Sep 2025
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