Effects of Malleo-Lok Stiffness on Lower Limb Mechanics

NCT04806100 | Completed Results FDA Device

• 1 other identifier: 202004402
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult ALL; Healthy

Keywords

Gait Analysis; Ankle Foot Orthosis; Carbon Fiber; Biomechanics

Outcome Measures

Primary Outcomes (3)

• Ankle Joint Stiffness

  Ground reaction force and ankle motion data were collected simultaneously using the force measurement and motion capture systems as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. The ankle motion data was plotted against the ankle moment data and the slope of the corresponding line was the resulting ankle joint stiffness (Nm/degree).

  In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes).

• Ankle Joint Power

  Peak ankle joint push-off power (W/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

  Ankle joint power was measured for each condition during short bouts of walking (~15-20 minutes).

• Ankle Joint Moment

  Peak ankle plantarflexion moment (Nm/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

  Ankle joint moment was measured for each condition during short bouts of walking (~15-20 minutes).

Secondary Outcomes (3)

• Numerical Pain Rating Scale

  Participants were asked to rate their pain after completing in-vivo ankle stiffness testing and walking trials in all conditions.

• Modified Socket Comfort Score: Comfort

  Participants were asked to rate their comfort after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions.

• Modified Socket Comfort Score: Smoothness

  Participants were asked to rate the orthosis smoothness after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions.

Other Outcomes (6)

• Center of Pressure Velocity Magnitude

  Baseline

• Center of Pressure Velocity Timing

  Baseline

• Soleus Muscle Activity (Electromyography)

  Baseline

Study Arms (6)

Compliant, NoCDO, Stiff

EXPERIMENTAL

Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO), then while wearing a stiff device (Stiff).

Device: Malleo-Lok

Compliant, Stiff, NoCDO

EXPERIMENTAL

Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff), then while wearing no brace (NoCDO).

Device: Malleo-Lok

NoCDO, Compliant, Stiff

EXPERIMENTAL

Participants will be tested while wearing no brace (NoCDO), then a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff).

Device: Malleo-Lok

NoCDO, Stiff, Compliant

EXPERIMENTAL

Participants will be tested while wearing no brace (NoCDO), then while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant).

Device: Malleo-Lok

Stiff, Compliant, NoCDO

EXPERIMENTAL

Participants will be tested while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO).

Device: Malleo-Lok

Stiff, NoCDO, Compliant

EXPERIMENTAL

Participants will be tested while wearing a stiff device (Stiff), then while wearing no brace (NoCDO), then while wearing a moderate stiffness device (Compliant).

Device: Malleo-Lok

Interventions

Malleo-Lok DEVICE

The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane.

Also known as: Ankle Foot Orthosis, Carbon Fiber Custom Dynamic Orthosis

Compliant, NoCDO, Stiff; Compliant, Stiff, NoCDO; NoCDO, Compliant, Stiff; NoCDO, Stiff, Compliant; Stiff, Compliant, NoCDO; Stiff, NoCDO, Compliant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Jason M Wilken, PT, PhD
• Organization: The University of Iowa

jason-wilken@uiowa.edu

319-335-6857

Study Officials

• Jason M Wilken, PT, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the stiffness of each brace. Braces will be labeled A and B, with stiffness only known by research staff.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 19, 2021
• Study Start: March 11, 2021
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: June 15, 2023
• Results First Posted: June 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)