Clinical trial NCT03848949: Study of an Orthotic Designed to Equalize Leg Lengths for Patients With Injuries Managed in Walking Boots
Official title: Prospective Randomized-controlled Trial of an Orthotic Designed to Equalize Leg Lengths for Patients With Injuries Managed in Walking Boots
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Pain
Trouble Balancing
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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.

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

Primary outcomes:
measure: Patient Reported Balance
timeFrame: 2 weeks
measure: Patient Reported Pain
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Kamran S Hamid, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.