Effects of Malleo-Lok Stiffness on Lower Limb Mechanics (NCT04806100) | Clinical Trial Compass
CompletedNot Applicable
Effects of Malleo-Lok Stiffness on Lower Limb Mechanics
United States20 participantsStarted 2021-03-11
Plain-language summary
The primary purpose of this research study is to determine if the stiffness of a commercially available ankle foot orthosis (Malleo-Lok, Bio-Mechanical Composites, Des Moines IA) impacts gait biomechanics and overall joint level stiffness. Previously published research suggests that AFO stiffness can affect gait biomechanics and patient preference. However, previous studies have focused on traditional posterior strut devices with the strut aligned in the frontal plane to allow sagittal plane deflection. The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane. The proposed study will provide insight that can be used by certified prosthetists orthotists (CPOs), physical therapists, and physicians to select the device that bests meets their patients' needs.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between the ages of 18 and 45
* Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months
* Able to hop without pain
* Able to perform a full squat without pain
* Ability to speak and understand English
Exclusion Criteria:
* Diagnosed with a moderate or severe brain injury
* Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
* Injuries that would limit performance in this study
* History of recurrent ankle sprains or chronic ankle instability
* Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
* Uncorrected visual or hearing impairment(s)
* Require use of an assistive device
* Unhealed wounds (cuts/abrasions) that would prevent AFO use
* BMI \> 35
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ankle Joint Stiffness
Timeframe: In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes).
2
Ankle Joint Power
Timeframe: Ankle joint power was measured for each condition during short bouts of walking (~15-20 minutes).
3
Ankle Joint Moment
Timeframe: Ankle joint moment was measured for each condition during short bouts of walking (~15-20 minutes).