N/A N=107 Randomized Prevention

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

Joint Pain · Trouble Balancing

Bottom Line

View on ClinicalTrials.gov: NCT03848949 ↗

Enrolled (actual)

107

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Patient Reported Balance — 3.0; 2.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Evenup (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Rush University Medical Center
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Reported Balance	3.0; 2.1	—
PRIMARY Patient Reported Pain	4.9; 3.9	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT03848949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.