CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 107 enrolled
Drug / intervention
Evenupdevice
Likely dose
Evenup orthotic device (leg-length equalizer)AI-extracted
Key inclusion· 2
  • Weight bearing as tolerated
  • At least 2 weeks of treatment in a controlled ankle movement boot
Key exclusion· 3
  • Achilles tendon rupture (treated with controlled ankle boot and heel lifts)
  • Member of a special population
  • Unwilling to participate

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

Search/NCT03848949
NCT03848949N/ACompleted

Prospective Randomized-controlled Trial of an Orthotic Designed to Equalize Leg Lengths for Patients With Injuries Managed in Walking Boots

Rush University Medical Center·interventional·Posted Feb 21, 2019·Updated Jun 10, 2021

In Brief

A clinical study evaluating Evenup for Joint Pain and Trouble Balancing. Completed, enrolled 107 participants across 1 site.

Detailed Summary

Patients who undergo foot and ankle surgery are often made weight-bearing as tolerated (WBAT) in a controlled ankle movement (CAM) boot during their recovery and rehabilitation process. However, some patients may experience pain and discomfort while wearing the CAM boot. A possible cause for this pain is that the boot elevates the injured foot higher than the other foot in the normal shoe. This uneven walking plane can lead to an abnormal gait or walking pattern, and may potentially lead to pain. Our goal is the investigate if using a leg-length-evening orthotic can improve balance and/or decrease the development of pain in the legs and spine for patients who are WBAT in a CAM boot.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 21, 2019
Enrollment StartJul 16, 2018
Primary CompletionOct 10, 2019
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.4 years ago

Interventions

Evenupdevice

Orthotic which increases effective leg length.