CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
RESTIFFIC™ Brand Pressure Application Systemdevice
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/NCT02386423
NCT02386423N/ACompleted
CompareCT.gov

Efficacy and Safety of the RESTIFFIC™ Brand Pressure Application System, the Restless Leg Relaxer to Reduce the Symptoms of Moderate to Severe Restless Leg Syndrome

Lake Erie Research Institute·interventional·Posted Mar 11, 2015·Updated Mar 11, 2015

In Brief

A clinical study evaluating RESTIFFIC™ Brand Pressure Application System for Restless Leg Syndrome. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and efficacy of RESTIFFIC™, a foot wrap that produces adjustable targeted pressure on specific muscles in the feet, to reduce the symptoms of moderate to severe primary Restless Legs Syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRestless Leg Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2015
Enrollment StartApr 1, 2009
Primary CompletionApr 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.3 years ago

Interventions

RESTIFFIC™ Brand Pressure Application Systemdevice

The device, RESTIFFIC™, was administered intermittently through the course of the study: one-week baseline period without the device (days 1-7), three weeks of initial testing with the device (days 8-28), a subsequent one-week period without the device (days 29-35), and three weeks of subsequent testing with the device (days 36-56).