BiomechanicsNCT05365594
Biomechanical Analysis of CAM Boot and EVENUp Lift
A study testing EVENUp Lift in people with Biomechanics and Limb Length Discrepancy, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomechanics, Limb Length Discrepancy
- What is being tested?
- EVENUp Lift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2022to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy cohort:
- Age of 18 to 40 years
- No history of lower extremity injury in last 5 years
- No history of lower limb discrepancy
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF & Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
Official title: Biomechanical Analysis of Gait in a Walking Boot With Contralateral Foot 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.
Read the detailed description
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.
- Conditions
- Biomechanics, Limb Length Discrepancy
- Being tested
- Controlled Ankle Movement Boot, EVENUp Lift
- Keywords
- CAM Boot, EVENup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Ankle Movement BootDevice
Walking boot used for orthopaedic foot injuries
EVENUp LiftDevice
Also called Foot Lift
Orthotic shoe lift worn on contralateral foot to increase leg length
| Study group | Role | What they receive |
|---|---|---|
| Self Selected Pace | Active comparator | Tennis shoes, CAM Boot, CAM Boot plus EvenUp Lift Receives: Device: Controlled Ankle Movement Boot; Device: EVENUp Lift |
| Speed Walking Pace | Active comparator | Tennis shoes, CAM Boot, CAM Boot plus EvenUp Lift Receives: Device: Controlled Ankle Movement Boot; Device: EVENUp Lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Take range of motion measurements of the spine
Measured: Day 1
Compare the differences in kinetics and kinematics of the lower extremities during normal gait and wearing a walking boot
Take range of motion measurements of the knee
Measured: 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
Take range of motion measurements of the knee
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start18 Aug 2022
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiomechanicsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Talerico, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365594
- Sponsor's protocol ID
- IRB202102519
- Status last verified
- Nov 2024
- First submitted
- 28 Apr 2022
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Analysis of Gait in a Walking Boot With Contralateral Foot Lift
- ClinicalTrials.gov ID
- NCT05365594
- Acronym / sponsor ID
- IRB202102519
- Conditions
- Biomechanics, Limb Length Discrepancy
- Keywords
- CAM Boot, EVENup
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Selected Pace | Active comparator | Device: Controlled Ankle Movement Boot, Device: EVENUp LiftTennis shoes, CAM Boot, CAM Boot plus EvenUp Lift |
| Speed Walking Pace | Active comparator | Device: Controlled Ankle Movement Boot, Device: EVENUp LiftTennis shoes, CAM Boot, CAM Boot plus EvenUp Lift |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy cohort:
- Age of 18 to 40 years
- No history of lower extremity injury in last 5 years
- No history of lower limb discrepancy
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled Ankle Movement BootWalking boot used for orthopaedic foot injuries | Device | Self Selected Pace, Speed Walking Pace |
| EVENUp LiftAlso: Foot LiftOrthotic shoe lift worn on contralateral foot to increase leg length | Device | Self Selected Pace, Speed Walking Pace |
Primary outcome
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
3 secondary outcomes
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
Compare the differences in kinetics and kinematics of the lower extremities during normal gait and wearing a walking boot
Time frame: 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
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Talerico, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVENUp Lift in people with Biomechanics and Limb Length Discrepancy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the differences in kinetics and kinematics of the spine during normal gait and wearing a walking boot (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.