Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04337554 |
| Other study ID # |
A3266-R |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2020 |
| Est. completion date |
September 30, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
VA Office of Research and Development |
| Contact |
Sara A Myers, PhD |
| Phone |
(402) 554-3246 |
| Email |
Sara.Myers2[@]va.gov |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to determine the best assistance level of an exoskeleton
footwear (EF) that can assist walking for people older than 40 with and without peripheral
artery disease (PAD). The test will be performed on two different groups of people for this
study that include: 1) people with PAD, and 2) individuals who don't have PAD.
Data will be collected from 50 healthy older individuals and 25 patients with PAD, both
groups will be 40 years or older.
Gait biomechanics, muscle oxygenation, and energy cost for seven different walking conditions
including normal walking, walking with EF with no assistance, and walking with EF with 5
different levels of assistance will be collected from the healthy older individuals.
Additionally, subject-reported outcomes after each walking conditions including perceived
comfort and fatigue, rate of perceived exertion and feasibility of the EF will be collected.
Gait biomechanics, muscle oxygenation, energy cost, and patient-reported outcomes will be
measured in patients with PAD for four walking conditions including normal walking, walking
with EF but no assistance, walking with EF with the best two assistance levels. Subjects will
be allowed to acclimate to the EF prior to recording data. All patients with PAD will
participate in feasibility interviews that will assess acceptability, demand, implementation,
and practicality.
All subjects will be asked to fill out questionnaires that assess quality of life, physical
function, and the ability to complete activities of daily living.
Description:
Claudication due to peripheral artery disease (PAD) causes patients to walk less and slower,
lose independence in daily living activities, and be sedentary compared to their healthy
counterparts. The investigators' research has identified functional limitations in the
walking patterns of claudicating patients. The most prominent and consistent deficit is of
the posterior calf muscles, the ankle plantarflexors, to generate healthy ankle torque and
power during walking. Previous work in the investigators' laboratory has established that
these functional deficits are related to the presence of a myopathy in the legs of patients
with PAD which is characterized by myofiber degeneration and muscle fibrosis. An intervention
that compensates for impaired muscle physiology and performance is needed to improve walking
ability and independence in patients with PAD.
The long-term goal of this project is to improve the quality of life of patients with PAD by
using assistive exoskeletons. Currently, there is a critical treatment gap for those patients
with PAD whose disease presentation does not warrant operative revascularization (based on
risk-benefit analysis that considers multiple factors including disease severity, comorbid
conditions and operative risk), but who desire to regain their walking ability and
independence. Ankle-foot orthoses have recently been implemented to reduce the demands for
biological ankle plantarflexor torque and to compensate for power deficiency. Biological
ankle torque/power is torque/power generated by the plantarflexor muscles apart from that
provided by an assistive device. The investigators have developed a lightweight and low-cost
3D printable elastic exoskeleton and footwear combination called exoskeleton footwear (EF).
The EF assists with push-off by using springs that mimic ankle plantarflexor forces.
Exoskeletons that assist propulsion address both the myopathy and low blood flow problems
associated with claudication. Mechanical force from the EF compensates for insufficient
muscle propulsion force, while decreasing blood flow demand and the muscular stress caused by
ischemia. A properly designed exoskeleton will likely allow patients with PAD to walk longer
without pain or walk the distance needed for completing daily activities with less stress to
the affected leg. As a first step the investigators propose to determine the effect of EF on
walking performance, focusing on how different levels of EF support contribute to changes in
the biological ankle torque and power, energy cost, and calf muscle oxygenation. The
investigators will test healthy older adults to ensure and confirm comfort, low risk of
injury to the foot and calf, and high potential for device adoption in patients with PAD.
The EF will then be evaluated in patients with PAD. Healthy older individuals are selected
for the initial phase of the project because, like patients with PAD, they produce less
push-off torque and power during walking compared with healthy young; making them an
appropriate model for PAD limitations. Furthermore, compared to patients with PAD, healthy
older can tolerate longer walking trials, which are necessary to identify effective device
parameters and also have a significantly lower risk of developing foot and calf injuries
while the comfort and shape of the EF are assessed and adjusted to accommodate individuals
with different foot and leg morphologies.
Hypothesis: Walking performance will improve with EF in healthy older and patients with PAD.
The investigators hypothesize there will be an EF assistance level to satisfy
subject-reported preference and walking performance goals.
Specific Aim 1: To determine the levels of EF assistance force which produce better walking
performance in older subjects. Improvements in walking performance will be assessed by
measuring how different levels of EF assistance contribute to changes in the biological ankle
torque and power during push-off, the energy cost of walking, and the calf muscle oxygenation
during walking.
Specific Aim 2: To determine the levels of EF assistance force which produce better
subject-reported preference in older subjects. Preference will be measured using
visual-analog scales, perceived exertion and pain questionnaires, and interview-style surveys
about acceptability (satisfaction, intent to use), demand (perceived demand), and
practicality (effects, ability of participants to use EF).
Specific Aim 3: To determine the effect of EF assistance levels on walking performance and
subject-reported preference in patients with PAD. Results from Aims 1 and 2 will guide the
assistance levels tested in this aim.
Research Design and Methods Healthy elderly will be evaluated in a total of seven conditions
in Aims #1 and #2: five different EF stiffness levels including EF: Stiffness 1 (5.6 kN/m),
EF Stiffness 2 (7.9 kN/m), EF Stiffness 3 (10.5 kN/m), EF Stiffness 4 (13.3 kN/m), EF
Stiffness 5 (17.2 kN/m), EF with a disengaged spring and one normal walking condition (no
EF).
PAD patients will be evaluated in four conditions in Aim #3: two different EF stiffness
levels, one condition in which the subjects will wear the EF with a disengaged spring and one
normal walking condition (no EF). Spring stiffness will be adjusted as a function of body
mass to provide a normalized torque input across subjects. These stiffness levels were chosen
based on previous research work using a similar, device in healthy young individuals. The EF
will be set to release the spring at 42% of the stride. Increases in energy cost at stiffness
values above and below the optimal value will be an indicator the stiffness levels are within
the appropriate scale. Healthy older adults and patients with PAD will be tested to determine
the effect of EF assistance force on walking performance and energy cost and subject-reported
preference with varying EF assistance levels
A total of 50 adults, ages 50 years and older from the Nebraska and Western Iowa Veterans
Affairs' Medical Center (VAMC) and the surrounding Omaha community to complete Aims 1 and 2
will be recruited. Aim 3 will include 25 patients with PAD recruited from the VAMC.
Data collection Protocol for Aims #1 and #2:
Walking: Subjects will complete seven minutes of walking at their preferred walking speed on
an instrumented treadmill (AMTI, Watertown, MA) while kinetics and kinematics are captured at
100 Hz with a 17 camera digital motion capture system (Cortex 6.2, Motion Analysis Corp,
Santa Rosa, CA). The three minutes of walking will be for subjects to get accustomed to the
new assistance level in the EF. Preferred walking speed will be determined prior to
collecting any data and it will be held consistent across the seven conditions.
Subject will also walk on flat ground for seven different conditions.
Muscle Oxygenation: Bilateral gastrocnemius muscle oxygenation (StO2) will be measured using
continuous-wave near infrared spectroscopy (PortaMon, Artinis Medical System, Netherlands)
before, during and after each treadmill walking condition (described above).
Energy cost: A portable metabolic cart will be used to measure gas exchange on a
breath-by-breath basis, providing a measure of oxygen consumption during each of the seven
treadmill walking conditions.
Perceived comfort and fatigue: A visual analog scale will be used to capture subjects'
perception of comfort and fatigue after each treadmill and flat ground condition. The visual
analog scale will range from 0 (low comfort; high fatigue) to 10 (high comfort; low fatigue).
Rate of perceived exertion: Self-reported perceived exertion values from the Borg Rate of
Perceived Exertion scale (6 (no exertion) to 20 (maximal exertion)) will be recorded after
each condition.
Data collection Protocol for Aims #3:
Walking performance and subject-reported preference will be assessed in the same manner as in
Aims 1 and 2 except the treadmill walking test will be replaced with maximum walking distance
tests (see description below). For this reason, testing will be divided into two days, with
two maximum walking distances tests completed on each day. Subjects will rest until any
claudication pain subsides between each maximum walking distance tests. Subjects will
complete testing of the same outcomes (1-7 below) exactly as described in Aims 1 and 2 and
maximum walking times (8 below). Maximum walking times are the best indicator of the
implications of PAD on daily walking ability and participation in community activities.
All outcomes from the older subject's protocol will be assessed for PAD patients including 1)
walking: On the treadmill test, biomechanics variables during the zero degree incline portion
of the test will be collected. Rest time will be given between the conditions as needed for
claudication pain to subside.
2) Muscle oxygenation, 3) Energy cost, 4) Perceived comfort and fatigue, 5) Rate of perceived
exertion, 6) Feasibility.
Two additional outcomes measured for the PAD patients will be:
Perceived pain: Following the approach of perceived comfort and fatigue, a visual analog
scale will be used to capture subjects' perception of pain after each condition. The visual
analog scale will range from 0 (no pain) to 10 (intense pain) and will be assess after each
EF condition.
Claudication Onset and Peak Walking Times: Walking ability will be determined with a
progressive-load treadmill test with initial and maximum claudication distances as outcomes.
Patients will walk on a treadmill that starts at 0% grade and 2.0 mph. Every two minutes, the
grade will be increase by 2% up to a maximum of 15% grade, and the speed held constant
throughout the test. The initial distance walked prior to the onset of pain (Claudication
Onset Time - COT) and the distance patients walked until the test had to be stopped due to
pain (Peak Walking Time -PWT) will be the outcome measures.
