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Completed

NCT Number: NCT03848949

Study 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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evenup

Device

Orthotic which increases effective leg length.

Primary outcomes

  1. 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. 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).

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 21, 2019
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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