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Improving Walking in Peripheral Artery Disease

Improving Walking in Peripheral Artery Disease Using Specially Designed Assistive Shoes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05103280
Acronym
PAD
Enrollment
10
Registered
2021-11-02
Start date
2021-10-01
Completion date
2024-09-30
Last updated
2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Disease

Keywords

Peripheral artery disease

Brief 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.

Detailed 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 using assistive shoes (either CF or SL, based on their preference) for three months will lead to improved walking performance in patients with PAD. The investigators also hypothesize that the subject-reported preference of assistive shoes (CF versus SL) will be positive based on comfort, fatigue, ease of walking, and feasibility at the baseline session. Two hypotheses will be tested by the following three specific aims: Aim 1: Determine the subject-reported preference of assistive shoes at the Baseline visit. Aim 2: 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. Aim 1 will primarily focus on qualitative measurements of subjects' reported preferences to identify which assistive shoes are feasible for patients with PAD to use during the three months of intervention. Visual-analog scales, rate of perceived exertion, and interviews will be used to assess comfort, fatigue, intensity, and feasibility after each shoe condition of Aim 1. Patients will wear the preferred 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 the 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.

Interventions

OTHERAssistive tennis shoes

Assistive shoes include carbon-fiber and spring loaded shoes.

Sponsors

University of Nebraska
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Ten patients will wear assistive shoes for 3 months.

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

At entry into the study, all patients must: * be able to give written, informed consent * demonstrate positive history of chronic claudication * have an ankle brachial index \< 0.90 at rest * have a stable blood pressure regimen, stable lipid regimen, stable diabetes regimen and risk factor control for 6 weeks

Exclusion criteria

Any potential subjects will be excluded if they have: * rest pain or tissue loss due to peripheral artery disease (Fontaine stage III and IV) * acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma * walking capacity significantly limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

Design outcomes

Primary

MeasureTime frameDescription
Changes in Walking Distance After Three-months InterventionBaseline and after three-months interventionIn this single-arm study, investigators assessed absolute claudication walking distance using the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by ParticipantsBaselineAt the baseline session, participants will be asked to rate the comfort of each assistive shoe on a scale from 0 to 10, where 0 indicates Low comfort and 10 indicates High comfort. During this session, all participants will walk in three different shoes and provide a comfort rating for each. Based on these ratings, one shoe will be selected for the participant to use over the following three months.

Secondary

MeasureTime frameDescription
Changes in Vertical Ground Reaction Force After Three-months InterventionBaseline and after three-months interventionIn this single-arm study, investigators assessed vertical ground reaction force from a pressure-instrumented treadmill during the Gardner treadmill test while walking in their normal shoes. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Changes in Muscle Oxygenation After Three-months InterventionBaseline and after three-months interventionIn this single-arm study, investigators will assess minimum muscle oxygenation during the Gardner treadmill test while wearing their normal shoes. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.
Changes in Physical Activity After Three-months InterventionBaseline and after three-months interventionIn this single-arm study, investigators calculated the average number of steps per day as a measure of physical activity using an ActiGraph accelerometer worn by participants. All participants underwent a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on their personal preference. No control group was included. Participants wore the accelerometer for 7 days before the intervention and again for 7 days after completing the three-month intervention period.
Changes in Rate of Perceived Exertion Score After Three-months InterventionBaseline and after three-months interventionIn this single-arm study, investigators assessed the rate of perceived exertion (RPE) immediately after the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included. The RPE score ranged from 6 to 20, where 6 indicated no exertion at all and 20 indicated maximal exertion.

Countries

United States

Participant flow

Participants by arm

ArmCount
Progressive Improvement in Walking Performance
A total of ten patients with peripheral artery disease will be enrolled for this arm and wear the assistive tennis shoes for three-months as an intervention. Assistive tennis shoes: Assistive shoes include carbon-fiber and spring loaded shoes.
10
Total10

Baseline characteristics

CharacteristicProgressive Improvement in Walking Performance
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
7 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
Age, Continuous70.3 years
STANDARD_DEVIATION 8.01
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
10 Participants
Region of Enrollment
United States
10 Participants
Sex: Female, Male
Progressive improvement in walking performance
Female
0 Participants
Sex: Female, Male
Progressive improvement in walking performance
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Changes in Walking Distance After Three-months Intervention

In this single-arm study, investigators assessed absolute claudication walking distance using the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.

Time frame: Baseline and after three-months intervention

ArmMeasureGroupValue (MEAN)Dispersion
Progressive Improvement in Walking PerformanceChanges in Walking Distance After Three-months InterventionBaseline289.68 metersStandard Deviation 196.11
Progressive Improvement in Walking PerformanceChanges in Walking Distance After Three-months InterventionAfter Three months262.95 metersStandard Deviation 165.97
Primary

Comfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participants

At the baseline session, participants will be asked to rate the comfort of each assistive shoe on a scale from 0 to 10, where 0 indicates Low comfort and 10 indicates High comfort. During this session, all participants will walk in three different shoes and provide a comfort rating for each. Based on these ratings, one shoe will be selected for the participant to use over the following three months.

Time frame: Baseline

ArmMeasureGroupValue (MEAN)Dispersion
Progressive Improvement in Walking PerformanceComfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participantsstandard shoe5.5 units on a scaleStandard Deviation 1.08
Progressive Improvement in Walking PerformanceComfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participantscarbon fiber5.9 units on a scaleStandard Deviation 2.3
Progressive Improvement in Walking PerformanceComfort Level of Wearing Assistive Shoe Expressed as a Numeric Value and This Value Will be Rated by Participantsspring loaded6.6 units on a scaleStandard Deviation 2.06
Secondary

Changes in Muscle Oxygenation After Three-months Intervention

In this single-arm study, investigators will assess minimum muscle oxygenation during the Gardner treadmill test while wearing their normal shoes. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.

Time frame: Baseline and after three-months intervention

ArmMeasureGroupValue (MEAN)Dispersion
Progressive Improvement in Walking PerformanceChanges in Muscle Oxygenation After Three-months InterventionBaseline36.82 Muscle oxygen saturation percentageStandard Deviation 15.92
Progressive Improvement in Walking PerformanceChanges in Muscle Oxygenation After Three-months InterventionAfter three months40.02 Muscle oxygen saturation percentageStandard Deviation 12.3
Secondary

Changes in Physical Activity After Three-months Intervention

In this single-arm study, investigators calculated the average number of steps per day as a measure of physical activity using an ActiGraph accelerometer worn by participants. All participants underwent a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on their personal preference. No control group was included. Participants wore the accelerometer for 7 days before the intervention and again for 7 days after completing the three-month intervention period.

Time frame: Baseline and after three-months intervention

ArmMeasureGroupValue (MEAN)Dispersion
Progressive Improvement in Walking PerformanceChanges in Physical Activity After Three-months InterventionBaseline4099.102 steps/dayStandard Deviation 4035.33
Progressive Improvement in Walking PerformanceChanges in Physical Activity After Three-months InterventionAfter three months intervention4740.85 steps/dayStandard Deviation 4913.19
Secondary

Changes in Rate of Perceived Exertion Score After Three-months Intervention

In this single-arm study, investigators assessed the rate of perceived exertion (RPE) immediately after the Gardner treadmill test while participants walked in their normal footwear. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included. The RPE score ranged from 6 to 20, where 6 indicated no exertion at all and 20 indicated maximal exertion.

Time frame: Baseline and after three-months intervention

ArmMeasureGroupValue (MEAN)Dispersion
Progressive Improvement in Walking PerformanceChanges in Rate of Perceived Exertion Score After Three-months InterventionBaseline12.6 score on a scaleStandard Deviation 2.7
Progressive Improvement in Walking PerformanceChanges in Rate of Perceived Exertion Score After Three-months InterventionAfter three months13.25 score on a scaleStandard Deviation 2.3
Secondary

Changes in Vertical Ground Reaction Force After Three-months Intervention

In this single-arm study, investigators assessed vertical ground reaction force from a pressure-instrumented treadmill during the Gardner treadmill test while walking in their normal shoes. This assessment was conducted both before and after a three-month intervention using assistive shoes-either carbon fiber or spring-loaded-selected based on participant preference. No control group was included.

Time frame: Baseline and after three-months intervention

ArmMeasureGroupValue (MEAN)Dispersion
Progressive Improvement in Walking PerformanceChanges in Vertical Ground Reaction Force After Three-months InterventionBaseline769.34 NewtonStandard Deviation 150.09
Progressive Improvement in Walking PerformanceChanges in Vertical Ground Reaction Force After Three-months Interventionafter three-months intervention845.38 NewtonStandard Deviation 118.24

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026