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Clinical Trials/NCT03848949
NCT03848949
Completed
N/A

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

Rush University Medical Center1 site in 1 country107 target enrollmentJuly 16, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Joint Pain
Sponsor
Rush University Medical Center
Enrollment
107
Locations
1
Primary Endpoint
Patient Reported Pain
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
July 16, 2018
End Date
December 1, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kamran S Hamid, MD

Orthopaedic Foot and Ankle Surgeon

Rush University Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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).

Study Sites (1)

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