Prospective Randomized-controlled Trial of an Orthotic Designed to Equalize Leg Lengths for Patients With Injuries Managed in Walking Boots
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 107
- Locations
- 2
- Primary Endpoint
- Patient Reported Pain
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Both patients and surgeons are aware whether they are being assigned to the control group or the experimental group
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Kamran S Hamid, MD
Orthopaedic Foot and Ankle Surgeon
Rush University Medical Center