Walkasins for Sensory Modulation Disorder

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 Modulation Disorder
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

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

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 more

Awards & 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

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