Ankle-foot Orthoses for Peripheral Artery Disease

NCT02280200 | Completed Results

• 2 other identifiers: Mays-2U54GM104944
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD).

Conditions

Peripheral Artery Disease

Keywords

claudication; ankle foot orthoses; community walking exercise

Outcome Measures

Primary Outcomes (5)

• Change in WIQ Distance Subscore

  In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

  12 weeks

• Change in WIQ Speed Subscore

  In the Walking Impairment Questionnaire speed subcategory, participants are asked to rate the degree of difficulty walking one block at specific speeds, ranging from walking slowly to jogging, on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

  12 weeks

• Change in WIQ Stair-Climbing Subscore

  In the Walking Impairment Questionnaire stair-climbing subcategory, participants are asked to rate the degree of difficulty climbing a specified number of stair flights, ranging from 1 to 3 stair flights, on a graded scale of 0 to 4. A score of 0 indicates the inability to climb the flights specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).

  12 weeks

• Change in SF-36 PCS

  Change in Medical Outcomes Study Short Form 36-item questionnaire, Physical Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.

  12 weeks

• Change in SF-36 MCS

  Change in Medical Outcomes Study Short Form 36-item questionnaire, Mental Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.

  12 weeks

Study Arms (2)

AFO to improve outcomes

EXPERIMENTAL

Patients completed graded treadmill testing, followed by 12 weeks of unstructured community-based walking using the AFO ad libitum

Device: AFO to improve outcomes

Historical Controls

NO INTERVENTION

Historical PAD control group (n = 10) received upfront advice to walk at home with no intervention

Interventions

AFO to improve outcomes DEVICE

Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.

AFO to improve outcomes

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women diagnosed with atherosclerotic peripheral arterial disease (PAD).
• Patients who experience calf claudication
• ≥40 years of age
• An abnormal ankle-brachial index (ABI) of ≤.90.
• For patients with an ABI \>.90 and \<1.00, a post-exercise ABI drop of 15% or more compared to the resting ABI

You may not qualify if:

• Lower extremity amputation(s) which interfere(s) with walking.
• Critical limb ischemia (i.e., ischemic rest pain, ulcers/gangrene on the lower extremities).
• Non-atherosclerotic PAD (e.g., popliteal entrapment syndrome, Takayasu's arteritis)
• Major surgical procedures that are contraindicated to an exercise program (e.g., recent organ transplant) or coronary artery bypass graft within 6 months prior to screening.
• Primarily limitations to exercise due to chronic obstructive pulmonary disease, angina or heart failure.
• Myocardial infarction within 3 months prior to screening.
• Acute coronary syndrome symptoms diagnosed at time of screening.
• Significant ischemic changes (documented on the 12-lead electrocardiogram) with horizontal or down-sloping ST-segment depression ≥ 0.5mm at rest and \>1 mm with exercise in 3 beats for 2 contiguous leads, relative to the PR-segment (or ST-segment elevation ≥1mm).
• Transient ischemic attack or stroke 3 months prior to screening.
• New left bundle branch block or sustained ventricular tachycardia \>30 seconds during screening.
• Uncontrolled hypertension defined as ≥180 systolic or ≥100 diastolic resting blood pressure during screening.
• Women who are pregnant (women of childbearing potential, a pregnancy test will be performed at screening.
• Individuals currently incarcerated.
• Evidence of acute impairment from alcohol or other illicit drugs.
• Lack of diabetes control (glycated hemoglobin \>12%)

Sponsors & Collaborators

• University of Minnesota: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

International Heart Institute of Montana Foundation

Missoula, Montana, 59802, United States

Location

Related Publications (1)

• Mays RJ, Mays AA, Mizner RL. Efficacy of ankle-foot orthoses on walking ability in peripheral artery disease. Vasc Med. 2019 Aug;24(4):324-331. doi: 10.1177/1358863X19831765. Epub 2019 Mar 29.

  PMID: 30924412 DERIVED

Related Links

• Click here for more information about the sponsor

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ryan Mays PhD, MPH, MS
• Organization: University of Minnesota

rjmays@umn.edu

612-625-0430

Study Officials

• Ryan J. Mays, PhD, MPH, MS

  International Heart Institute of Montana Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: October 31, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 31, 2019
• Results First Posted: July 31, 2019

Record last verified: 2019-07

Locations

US (1)