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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2019-12-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Joint Pain Trouble Balancing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects are randomly assigned to two groups using a blocked randomization schedule.

Subjects assigned to the control group receive the standard treatment for their condition, which must be at least 2 weeks of weight bearing as tolerated in a controlled ankle movement boot in order for them to meet inclusion criteria.

Subjects assigned to the experimental group receive the orthotic for use on the contralateral limb, which is the only alteration to their treatment of at least 2 weeks of weight bearing as tolerated in a controlled ankle movement boot (required to meet inclusion criteria).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Both patients and surgeons are aware whether they are being assigned to the control group or the experimental group

Study Groups

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Orthotic Group

Subjects enrolled in the orthotic group receive the orthotic (Evenup) meant to increase the effective leg length of the uninjured limb.

Group Type EXPERIMENTAL

Evenup

Intervention Type DEVICE

Orthotic which increases effective leg length.

Control

Subjects enrolled in the control group receive the standard treatment associated with their injury (no orthotic)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Evenup

Orthotic which increases effective leg length.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No