Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05103280 |
| Other study ID # |
F3877-P |
| Secondary ID |
I21RX003877 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
September 30, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Peripheral artery disease (PAD) is a cardiovascular disease manifesting from systemic
atherosclerosis that blocks the leg arteries and results in insufficient blood flow to the
lower extremities. Limb ischemia from PAD is the most common disorder treated within the
vascular surgical service of the Omaha Veterans Affairs Medical Center. PAD also accounts for
one-third of the operations performed in the VA Medical Centers nationwide. The risk of
mortality of Veterans with PAD is substantial; nearly 30% of Veterans with PAD died within
3.8 years of diagnosis. This project aims to establish the feasibility and acceptability of
specially designed assistive shoes in patients with PAD and to determine if there are any
potential benefits of using these shoes over standard shoes. These assistive shoes may enable
patients to carry out desired activities of daily living with less pain and more physical
activity. Increasing physical activity will decrease morbidity and mortality. If proven
beneficial, the findings will lead to a novel and conservative rehabilitation protocol that
directly benefits Veterans nationwide.
Description:
The long-term goal of this project is to improve mobility, functional independence, and
quality of life in patients with peripheral artery disease (PAD) by using specially designed
assistive shoes. PAD is a manifestation of systemic atherosclerosis producing blockages in
the leg arteries, resulting in insufficient blood flow to the lower extremities. Limb
ischemia from PAD is the most common disorder treated within the vascular surgical service of
the Omaha Veterans Affairs Medical Center. PAD also accounts for one-third of the operations
performed nationwide in the VA. Walking induced muscle pain known as intermittent
claudication is the most common PAD symptom. Claudicating patients with PAD walk slower, have
reduced quality of life and lose independence in performing activities of daily living. The
investigators have identified consistent deficits of the ankle plantarflexors to effectively
push-off during walking. Currently, there is a critical treatment gap for patients whose
disease presentation does not warrant an operative approach, but who desire to restore their
functional independence and walking ability. Specially designed assistive shoes (carbon
fiber: CF; spring-loaded: SL) with specific mechanical properties to absorb and release
energy, have been shown to promote push-off efficiency in walkers and runners. These shoes
may lead to improved push-off in populations with reduced ankle push-off capacity, but this
has not been tested yet. This work proposes to evaluate patient preferences in terms of using
assistive shoes and whether these shoes improve walking performance in claudicating patients
with PAD. The investigators hypothesize that assistive shoes (CF and SL) will lead to
improved walking performance in patients with PAD as compared to standard shoes. The
investigators also hypothesize that subject reported preference of assistive shoes (CF and
SL) will be positive based on comfort, fatigue, ease of walking, and feasibility. These
hypotheses will be tested by the following three specific aims:
Aim 1: Determine the acute improvement in walking performance (claudication walking
distances, vertical ground reaction force, and muscle oxygenation) in patients with PAD while
using their standard shoes versus the assistive shoes.
Aim 2: Determine the subject-reported preference of assistive shoes. Aim 3: Determine the
progressive improvements in physical activity, quality of life, and walking distance after a
three-month assistive shoe intervention.
Twenty patients with PAD will be recruited for Aims 1 and 2. For Aim 1, each subject will
walk on a pressure instrumented treadmill while performing a progressive treadmill test with
a near infrared spectroscopy sensor on the calf for each shoe condition: i) standard, ii) CF,
and iii) SL. Walking performance will be evaluated in terms of claudication walking
distances, vertical ground reaction force, and muscle oxygenation. All outcomes will be
compared across these three types of shoes. Aim 2 will primarily focus on qualitative
measurements of subject reported preference to identify whether assistive shoes are feasible
for patients with PAD to use. Visual-analog scales, rate of perceived exertion, and
interviews will be used to assess comfort, fatigue, intensity, and feasibility after each
condition of Aim 1. Five patients from Aims 1 and 2 who are satisfied with CL and another
five who are satisfied with SL, will be recruited for Aim 3. Patients will wear the assistive
shoes of their choice for regular daily use for three months as a conservative intervention.
Physical activity, quality of life, and walking distances will be assessed prior to the start
of the intervention and after three months of intervention. Overall, the aims will
demonstrate feasibility and acceptability of assistive shoes in patients with PAD. Results
will support a full clinical trial, and guide necessary intervention length and potential
rehabilitation recommendations.
