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Completed

NCT Number: NCT05365594

Biomechanical Analysis of CAM Boot and EVENUp Lift

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.

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Key information

Conditions

Biomechanics Limb Length Discrepancy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

About this study

The goal of this study is to understand the kinematic effects of a walking boot on joint angles, moment arms and ground reaction forces in the spine and lower extremities. Additionally, the investigators will examine the effects a corrective foot lift, EVENup, has on these variables. This goal will be accomplished through (2) aims:

Aim 1. Compare the differences in kinetics and kinematics of the spine and lower extremities during normal gait and wearing a walking boot.

Aim 2. Compare spine and lower extremity kinetics and kinematics differences in a walking boot with and without the use of a corrective foot lift on contralateral leg.

Hypothesis: A contralateral foot lift will significantly reduce the altered mechanics created by a walking boot. These results would encourage physicians to recommend a contralateral foot lift when prescribing a walking boot to decrease secondary site pain.

Methodology: All subjects will participate in a gait analysis session in which their joint kinematics and kinetics will be recorded using skin-marker motion capture and treadmill force plates. Skin-marker motion capture involves placing reflective markers on palpable bony landmarks, such as the medial and lateral malleoli. These reflective markers are secured to the subject's skin using adhesive tape. Specialized, infrared cameras are then used to record the location of these markers as the subject walks at a self-selected speed and a specified speed denoted as faster pace. A self-selected speed will be determined by slowing increasing the speed of the treadmill until the subject feels like they are walking at a comfortable everyday speed. The faster pace will be determined by having the subject walk as if they are speed walking.

Participants will complete two trials with 3 different scenarios in each trial : 1) treadmill walking with regular shoes, 2) treadmill with walking boot and 3) treadmill with walking boot and corrective lift. Each participant's trial order will be randomized.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Controlled Ankle Movement Boot

Device

Walking boot used for orthopaedic foot injuries

EVENUp Lift

Device

Orthotic shoe lift worn on contralateral foot to increase leg length

Other names: Foot Lift

Primary outcomes

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

    Time frame: Day 1

    Take range of motion measurements of the spine

Secondary outcomes

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

    Time frame: Day 1

    Take range of motion measurements of the spine

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

    Time frame: Day 1

    Take range of motion measurements of the knee

  3. 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

    Time frame: Day 1

    Take range of motion measurements of the knee

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Biomechanical Analysis of Gait in a Walking Boot With Contralateral Foot Lift

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 9, 2022
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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