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Wearable Device
walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis
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
No Placebo-Only Group
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 Disturbance
- Sensory Disorders
- Peripheral Neuropathy
- Vestibular Dysfunction
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, week 6, week 10 (primary endpoint), week 26, and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 6, week 10 (primary endpoint), week 26, and week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Functional Gait Assessment
Secondary study objectives
10-Meter Walk Test
Activities-specific Balance Confidence (ABC) Scale
Falls
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.