N/A
N=20
Effects of Malleo-Lok Stiffness on Lower Limb Mechanics
Adult ALL · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04806100 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Ankle Joint Stiffness — 0.62; 0.97; 0.98 Nm/degree
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Malleo-Lok (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ankle Joint Stiffness |
0.62; 0.97; 0.98 | — |
| PRIMARY Ankle Joint Power |
2.8; 2.2; 2.1 | — |
| PRIMARY Ankle Joint Moment |
1.4; 1.3; 1.3 | — |
| SECONDARY Numerical Pain Rating Scale |
0.1; 0.2; 0.2 | — |
| SECONDARY Modified Socket Comfort Score: Comfort |
7.5; 8.0 | — |
| SECONDARY Modified Socket Comfort Score: Smoothness |
7.8; 7.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04806100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.