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

NCT03848949 | Completed Results FDA Device

• 1 other identifier: ORA: 18012208-IRB02
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Pain; Trouble Balancing

Outcome Measures

Primary Outcomes (2)

• Patient Reported Balance

  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

  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

Study Arms (2)

Orthotic Group

EXPERIMENTAL

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

Device: Evenup

Control

NO INTERVENTION

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

Interventions

Evenup DEVICE

Orthotic which increases effective leg length.

Orthotic Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

• White R, Schuren J, Wardlaw D, Diamandopoulos Z, Anderson R. Biomechanical assessment of gait in below-knee walking casts. Prosthet Orthot Int. 1999 Aug;23(2):142-51. doi: 10.3109/03093649909071626.

  PMID: 10493142 BACKGROUND

• Ferrari R. Effect of customized foot orthotics in addition to usual care for the management of chronic low back pain following work-related low back injury. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):359-63. doi: 10.1016/j.jmpt.2013.06.002. Epub 2013 Jul 3.

  PMID: 23830710 BACKGROUND

• Cambron JA, Dexheimer JM, Duarte M, Freels S. Shoe Orthotics for the Treatment of Chronic Low Back Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Sep;98(9):1752-1762. doi: 10.1016/j.apmr.2017.03.028. Epub 2017 Apr 30.

  PMID: 28465224 BACKGROUND

• Ferrari R. Responsiveness of the short-form 36 and oswestry disability questionnaire in chronic nonspecific low back and lower limb pain treated with customized foot orthotics. J Manipulative Physiol Ther. 2007 Jul-Aug;30(6):456-8. doi: 10.1016/j.jmpt.2007.03.016.

  PMID: 17693336 BACKGROUND

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Daniel D. Bohl
• Organization: Rush University Medical Center

danielbohl@gmail.com

414.640.7245

Study Officials

• Kamran S Hamid, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both patients and surgeons are aware whether they are being assigned to the control group or the experimental group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Foot and Ankle Surgeon

Model Details: 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).

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: July 16, 2018
• Primary Completion: October 10, 2019
• Study Completion: December 1, 2019
• Last Updated: June 10, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)