Effects of Malleo-Lok Stiffness on Lower Limb Mechanics (MalleoLokStiff)

• ClinicalTrials.gov Identifier: NCT04806100
• Recruitment Status: Active, not recruiting
• First Posted: March 19, 2021
• Last Update Posted: October 28, 2021
• Sponsor: University of Iowa
• Information provided by (Responsible Party): Jason Wilken, University of Iowa

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Adult ALL; Healthy	Device: Malleo-Lok	Not Applicable

Detailed Description:

Healthy adult individuals will be invited to participate in this study, at the University of Iowa, that involves one visit lasting 3-4 hours. The primary purpose of this work is to determine the effects of Malleo-Lok stiffness on gait biomechanics and ankle joint stiffness. Previous work has highlighted the effects of ankle foot orthosis stiffness on gait using devices with a traditional single posterior strut opposed to the Malleo-Lok, which has two laterally positioned struts. Orthosis stiffness is an important factor to consider during device prescription and manufacturing. The ability to tune overall joint level stiffness by determining the combined effects of biological limb stiffness and orthosis stiffness will enhance precision medicine when treating individuals who require an orthosis for daily activities. The secondary purpose of this research study is to determine the within session repeatability of a novel approach for in-vivo AFO stiffness testing. AFO stiffness testing is typically performed using mechanical testing systems without accounting for the interaction of the individual and the device.

During the visit to the University of Iowa campus participants will review a list of inclusion and exclusion criteria to determine their eligibility for this study. Eligible participants will review an informed consent document and have the chance to ask any questions they may have. Study staff will thoroughly explain the informed consent document and answer all questions. Upon signing the informed consent document study activities will begin. Participants will complete all study activities wearing no brace and two braces of differing stiffness's. Anthropometric and demographic information will be collected from each participant. The investigators will also use a motion capture system to evaluate gait biomechanics and ankle joint stiffness. Participants will walk at a self-selected and a controlled speed to evaluate gait biomechanics, and will stand in the motion capture system and bring their knee forward over the foot to evaluate ankle joint stiffness. Participants will be provided visual feedback of muscle activity to minimize lower limb muscle activity during ankle stiffness testing.

Results from the proposed study will provide information about the effects of orthosis stiffness on gait biomechanics and ankle joint stiffness. Study results will be made available to clinicians to use when prescribing and fitting individuals with ankle foot orthoses.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: All participants will be tested wearing no brace and two braces of differing stiffness's. The testing order will be randomized for each participant to prevent testing order from influencing study results.
• Masking: Single (Participant)
• Masking Description: Participants will be blinded to the stiffness of each brace. Braces will be labeled A and B, with stiffness only known by research staff.
• Primary Purpose: Basic Science
• Official Title: Effects of Malleo-Lok Stiffness on Lower Limb Mechanics
• Actual Study Start Date: March 11, 2021
• Actual Primary Completion Date: October 20, 2021
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: No Brace; Participants will be tested while wearing no brace.
Experimental: CDO-A; The first brace tested will be labeled CDO-A, this will be either the stiff or the compliant device.	Device: Malleo-Lok; The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane.; Other Names: Ankle Foot Orthosis; Carbon Fiber Custom Dynamic Orthosis
Experimental: CDO-B; The second brace tested will be labeled CDO-B, this will be either the stiff or the compliant device.	Device: Malleo-Lok; The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane.; Other Names: Ankle Foot Orthosis; Carbon Fiber Custom Dynamic Orthosis

Outcome Measures

Primary Outcome Measures :

1. Ankle Joint Stiffness [ Time Frame: Baseline ]
   Ground reaction force and ankle motion data collected simultaneously using the motion capture and force measurement systems will be combined to calculated ankle joint stiffness (Nm/deg).
2. Ankle Joint Moment [ Time Frame: Baseline ]
   Peak ankle joint moment (Nm/kg) during gait.
3. Ankle Joint Power [ Time Frame: Baseline ]
   Peak ankle joint moment (W/kg) during gait.
4. Center of Pressure Velocity Timing [ Time Frame: Baseline ]
   Timing of peak center of pressure velocity (percent stance) during gait.
5. Center of Pressure Velocity Magnitude [ Time Frame: Baseline ]
   Magnitude of peak center of pressure velocity (m/s) during gait.

Secondary Outcome Measures :

1. Modified Socket Comfort Score (Comfort and Smoothness) [ Time Frame: Baseline ]
   Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.
2. Numerical Pain Rating Scale [ Time Frame: Baseline ]
   Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
3. Soleus Muscle Activity [ Time Frame: During Testing ]
   Muscle activity will be measured using wireless DELSYS EMG sensors.
4. Medial Gastrocnemius Muscle Activity [ Time Frame: During Testing ]
   Muscle activity will be measured using wireless DELSYS EMG sensors.
5. Tibialis Anterior Muscle Activity [ Time Frame: During Testing ]
   Muscle activity will be measured using wireless DELSYS EMG sensors.
6. Peroneus Longus Muscle Activity [ Time Frame: During Testing ]
   Muscle activity will be measured using wireless DELSYS EMG sensors.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

Investigators

• Principal Investigator: Jason M Wilken, PT, PhD; University of Iowa

More Information

• Responsible Party: Jason Wilken, Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT04806100
• Other Study ID Numbers: 202004402
• First Posted: March 19, 2021
• Last Update Posted: October 28, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jason Wilken, University of Iowa:

Gait Analysis; Ankle Foot Orthosis; Carbon Fiber; Biomechanics

Additional relevant MeSH terms:

Carbon Fiber; Anti-Infective Agents, Local; Anti-Infective Agents