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

May 15, 2021 updated by: Kamran S Hamid, MD, Rush University Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with foot and ankle injuries are often made weight-bearing as tolerated (WBAT) in a controlled ankle movement (CAM) boot at some point during their recovery and rehabilitation period. While WBAT in a CAM boot, patients often experience an asymmetric gait associated with the effective leg length discrepancy between the booted extremity (longer) and the contralateral extremity with a regular shoe (shorter). This asymmetry may cause balance problems or place strain on the patient's joints resulting in back, knee, and hip pain.

An orthotic has been designed that is added to the outside of a regular shoe in order to eliminate the effective leg length discrepancy between the booted extremity and the contralateral limb. Although this specific orthotic has not been studied, some proof of concept lies in studies that show that back pain can be managed with foot orthotics. The purpose of this study is to determine if using the leg-length-evening orthotic can improve balance and/or decrease the development of pain in the lower extremities and spine for patients who are WBAT in a CAM boot.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • must be weight bearing as tolerated and treated for at least 2 weeks in a controlled ankle movement boot.

Exclusion Criteria:

  • unwilling to participate
  • being treated for an Achilles tendon rupture (and therefore being treated in a controlled ankle boot with heel lifts)
  • member of a special population

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orthotic Group
Subjects enrolled in the orthotic group receive the orthotic (Evenup) meant to increase the effective leg length of the uninjured limb.
Device: Evenup
Orthotic which increases effective leg length.
No Intervention: Control
Subjects enrolled in the control group receive the standard treatment associated with their injury (no orthotic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Balance
Time Frame: 2 weeks
Patient reported assessment of their balance while wearing the controlled ankle movement boot on a scale of 1 - 10 (higher values indicate better balance).
2 weeks
Patient Reported Pain
Time Frame: 2 weeks
Patient reported assessment of joint pain while wearing the controlled ankle movement boot on scales of 1 - 10 (higher values indicate more pain).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Kamran S Hamid, MD, Rush University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2018

Primary Completion (Actual)

October 10, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

May 15, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORA: 18012208-IRB02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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