Adult ALLMalleoLokStiffNCT04806100

Effects of Malleo-Lok Stiffness on Lower Limb Mechanics

A study testing Malleo-Lok in people with Adult ALL and Healthy, run by University of Iowa at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Adult ALL, Healthy
What is being tested?: Malleo-Lok
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 11 Mar 2021to 20 Oct 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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)

Show all 10Show fewer

Require use of an assistive device
Unhealed wounds (cuts/abrasions) that would prevent AFO use
BMI > 35
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Iowa
Iowa City, Iowa, 52242

Other trials in United States

About this study

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.

Read the 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.

Conditions: Adult ALL, Healthy
Being tested: Malleo-Lok
Keywords: Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Malleo-LokDevice
Also called Ankle Foot Orthosis, Carbon Fiber Custom Dynamic Orthosis
The Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane.

Study groups in NCT04806100
Study group	Role	What they receive
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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: Device: Malleo-Lok

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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 on a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Participants were asked to rate their pain after completing testing in no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.
Measured: 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
Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the comfort of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.
Measured: 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
Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the smoothness of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.
Measured: Participants were asked to rate the orthosis smoothness after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 202120 Oct 2021

First posted19 Mar 2021
Study start11 Mar 2021
Primary completion20 Oct 2021
Study completion20 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adult ALLStudies of the same condition, open and under way.
More trials run by University of IowaThe 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: Basic science
Allocation: Randomised
Intervention model: Crossover
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 blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04806100
Sponsor's protocol ID: 202004402
Acronym: MalleoLokStiff
Status last verified: May 2023
First submitted: 11 Mar 2021
Last updated: 15 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Adult ALL trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Malleo-Lok Stiffness on Lower Limb Mechanics
ClinicalTrials.gov ID: NCT04806100
Acronym / sponsor ID: MalleoLokStiff / 202004402
Conditions: Adult ALL, Healthy
Keywords: Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of IowaUniversity, hospital or other
Study start: 11 Mar 2021 (actual)
Primary completion: 20 Oct 2021 (actual)
Study completion: 20 Oct 2021 (actual)
First posted: 19 Mar 2021 (actual)
Results: Posted 15 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6
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.

Arm	Type	Receives
Compliant, NoCDO, Stiff	Experimental	Device: Malleo-LokParticipants will be tested while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO), then while wearing a stiff device (Stiff).
Compliant, Stiff, NoCDO	Experimental	Device: Malleo-LokParticipants will be tested while wearing a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff), then while wearing no brace (NoCDO).
NoCDO, Compliant, Stiff	Experimental	Device: Malleo-LokParticipants will be tested while wearing no brace (NoCDO), then a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff).
NoCDO, Stiff, Compliant	Experimental	Device: Malleo-LokParticipants will be tested while wearing no brace (NoCDO), then while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant).
Stiff, Compliant, NoCDO	Experimental	Device: Malleo-LokParticipants will be tested while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO).
Stiff, NoCDO, Compliant	Experimental	Device: Malleo-LokParticipants will be tested while wearing a stiff device (Stiff), then while wearing no brace (NoCDO), then while wearing a moderate stiffness device (Compliant).

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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)

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
Malleo-LokAlso: Ankle Foot Orthosis, Carbon Fiber Custom Dynamic OrthosisThe Malleo-Lok is a novel, low-profile carbon fiber device with two laterally positioned struts aligned in the sagittal plane.	Device	Compliant, NoCDO, Stiff, Compliant, Stiff, NoCDO, NoCDO, Compliant, Stiff, NoCDO, Stiff, Compliant, Stiff, Compliant, NoCDO, Stiff, NoCDO, Compliant

Primary outcome

Ankle Joint Stiffness
Time frame: In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes).
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).
Ankle Joint Power
Time frame: Ankle joint power was measured for each condition during short bouts of walking (~15-20 minutes).
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 Moment
Time frame: Ankle joint moment was measured for each condition during short bouts of walking (~15-20 minutes).
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.

3 secondary outcomes

Numerical Pain Rating Scale
Time frame: 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
Time frame: 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
Time frame: Participants were asked to rate the orthosis smoothness after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions.

Results and safety

Results posted to the registry on 15 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Compliant, NoCDO, Stiff	5	5
Compliant, Stiff, NoCDO	5	5
NoCDO, Compliant, Stiff	3	3
NoCDO, Stiff, Compliant	2	2
Stiff, Compliant, NoCDO	4	4
Stiff, NoCDO, Compliant	1	1

Primary outcome: Ankle Joint Stiffness

Time frame: In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes).. Mean (Standard Deviation). Unit: Nm/degree

Measure	NoCDO n = 20	Compliant n = 20	Stiff n = 20
Value	0.62 (0.32)	0.97 (0.34)	0.98 (0.34)

Population analysed: All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order.

Primary outcome: Ankle Joint Power

Time frame: Ankle joint power was measured for each condition during short bouts of walking (~15-20 minutes).. Mean (Standard Deviation). Unit: W/kg

Measure	NoCDO n = 20	Compliant n = 20	Stiff n = 20
Value	2.8 (0.5)	2.2 (0.4)	2.1 (0.3)

Primary outcome: Ankle Joint Moment

Time frame: Ankle joint moment was measured for each condition during short bouts of walking (~15-20 minutes).. Mean (Standard Deviation). Unit: Nm/kg

Measure	NoCDO n = 20	Compliant n = 20	Stiff n = 20
Value	1.4 (0.1)	1.3 (0.1)	1.3 (0.1)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study participants were asked to indicate any adverse events throughout the duration of the study visit. After completion of the study visit participants were also asked to call or email the research team if any adverse events related to the study occurred after the study visit (up to ~12 months after the visit).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NoCDO	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Compliant	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Stiff	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Jason M Wilken, PT, PhD principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Malleo-Lok in people with Adult ALL and Healthy, run by University of Iowa 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 5 inclusion and 10 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 15 Jun 2023. 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?

Yes. Results are posted in the registry (first posted 15 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Ankle Joint Stiffness (time frame: In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04806100.

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 15 Jun 2023.