Biomechanical Analysis of CAM Boot and EVENUp Lift

NCT05365594 | Completed

• 1 other identifier: IRB202102519
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Walking boots are a common form of durable medical equipment Orthopaedic surgeons prescribe both post-operatively and in the treatment of lower extremity injuries. Walking boots create a limb length discrepancy (LLD) which effects joint angles and moment arms in the lower extremities and the spine. These altered mechanics lead to reported back, hip, and knee pain in patients who are prescribed walking boots. Current walking boot literature evaluates gait and ground reaction forces (GRF), focusing primarily on the lower extremities, neglecting the remainder of the kinetic chain including the spine. Alternatively, there is a body of literature evaluating the effects of congenital LLD on spine and posture. However, there is paucity in the literature reporting both the effects of a walking boot on the entire kinematic chain and the subsequent effects of a corrective foot lift. The investigators seek to evaluate lower extremity and spinal kinematics using a motion analysis capture system with healthy subjects undergoing walking trials while wearing normal shoes, a walking boot, and a walking boot with contralateral foot lift. The investigators hypothesize a corrective foot lift will decrease the asymmetrical effects of a walking boot, recreating the kinematics of a more normal gait.

Conditions

Biomechanics; Limb Length Discrepancy

Keywords

CAM Boot; EVENup

Outcome Measures

Primary Outcomes (1)

• Compare the differences in kinetics and kinematics of the spine during normal gait and wearing a walking boot

  Take range of motion measurements of the spine

  Day 1

Secondary Outcomes (3)

• Compare spine kinetics and kinematics differences in a walking boot with and without the use of a corrective foot lift on contralateral leg

  Day 1

• Compare the differences in kinetics and kinematics of the lower extremities during normal gait and wearing a walking boot

  Day 1

• Compare the differences in kinetics and kinematics differences in a walking boot with and without the use of a corrective foot lift on contralateral leg

  Day 1

Study Arms (2)

Self Selected Pace

ACTIVE COMPARATOR

Tennis shoes, CAM Boot, CAM Boot plus EvenUp Lift

Device: Controlled Ankle Movement Boot; Device: EVENUp Lift

Speed Walking Pace

ACTIVE COMPARATOR

Tennis shoes, CAM Boot, CAM Boot plus EvenUp Lift

Device: Controlled Ankle Movement Boot; Device: EVENUp Lift

Interventions

Controlled Ankle Movement Boot DEVICE

Walking boot used for orthopaedic foot injuries

Self Selected Pace; Speed Walking Pace

EVENUp Lift DEVICE

Orthotic shoe lift worn on contralateral foot to increase leg length

Also known as: Foot Lift

Self Selected Pace; Speed Walking Pace

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy cohort:
• Age of 18 to 40 years
• No history of lower extremity injury in last 5 years
• No history of lower limb discrepancy

You may not qualify if:

• Pregnant women; minors (under age 18); mentally disabled; any persons incarcerated, on parole, on probation, or awaiting trial.
• Persons with medical history of spinal, hip, or other musculoskeletal pathology that may alter walking mechanics.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

Study Officials

• Michael Talerico, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 9, 2022
• Study Start: August 18, 2022
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)