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Study of an Orthotic Designed to Equalize Leg Lengths for Patients With Injuries Managed in Walking Boots

NCT03848949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2021-06-10

Study results available
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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.

Conditions

Interventions

DEVICE

Evenup

Orthotic which increases effective leg length.

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Kamran S Hamid, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2019-10-10
Completion
2019-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03848949 on ClinicalTrials.gov