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Ankle-foot Orthoses for Peripheral Artery Disease

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ClinicalTrials.gov Identifier: NCT02280200
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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).

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: AFO to improve outcomes Not Applicable

Detailed Description:
The investigators will test the hypothesis that PAD patients using an AFO during a graded exercise test will demonstrate a greater PWT compared to PWT assessed without the use of an AFO. Secondary hypotheses include evaluation of the effect of an AFO on: 1) calf muscle function, 2) claudication onset time, 3) functional ability, 4) peak oxygen consumption, and 5) patient-reported outcomes. We will also examine the effects of the AFO on outcomes following 12 weeks of community walking.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Ankle-Foot Orthoses on Walking Ability in Peripheral Artery Disease: The AFO for PAD Trial I
Study Start Date : November 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AFO to improve outcomes
open label, non-interventional design (all patients who volunteer for trial receive AFO)
Device: AFO to improve outcomes
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.



Primary Outcome Measures :
  1. Difference in PWT with and without the AFO [ Time Frame: cross-sectional (within 1 week) ]
    Assessed with a graded treadmill test


Secondary Outcome Measures :
  1. Difference in ankle power propulsion and calf muscle recruitment with and without the AFO [ Time Frame: cross-sectional (within 1 week) ]
    Assessed with a motion analysis system and surface electromyography sensors

  2. Difference in claudication onset time with and without the AFO [ Time Frame: cross-sectional (within 1 week) ]
    Assessed with a graded treadmill test

  3. Difference in functional ability with and without the AFO [ Time Frame: cross-sectional (within 1 week) ]
    Assessed with the 6-minute walk test

  4. Difference in peak oxygen uptake with and without the AFO [ Time Frame: cross-sectional (within 1 week) ]
    Assessed with a respiratory-metabolic analyzer

  5. Change in PWT with and without the AFO [ Time Frame: Baseline and post-12 weeks (with and without AFO at each timepoint) ]
    Assessed with a graded treadmill test

  6. Change in ankle power propulsion and calf muscle recruitment [ Time Frame: Baseline and post-12 weeks (with and without AFO at each timepoint) ]
    Assessed with a motion analysis system and surface electromyography sensors

  7. Change in claudication onset time [ Time Frame: Baseline and post-12 weeks (with and without AFO at each timepoint) ]
    Assessed with a graded treadmill test

  8. Change in functional ability [ Time Frame: Baseline and post-12 weeks (with and without AFO at each timepoint) ]
    Assessed with the 6-minute walk test

  9. Change in peak oxygen uptake [ Time Frame: Baseline and post-12 weeks (with and without AFO at each timepoint) ]
    Assessed with a respiratory-metabolic analyzer

  10. Change in patient-reported outcomes [ Time Frame: Baseline and post-12 weeks ]
    Assessed with the Walking Impairment Questionnaire and the Medical Outcomes Short Form 36-item questionnaire

  11. Change in calf and quadriceps circumference [ Time Frame: Baseline and post-12 weeks ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 ilicit drugs.
  • Lack of diabetes control (glycated hemoglobin >12%)
  • Patients who are anemic (Hgb <11 g/dL for women and <10 g/dL for men).
  • Any other clinically significant diseases (e.g., pulmonary, renal, psychiatric, immunological) that are not stabilized or may otherwise confound the results of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280200


Locations
United States, Montana
International Heart Institute of Montana Foundation
Missoula, Montana, United States, 59802
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Ryan J. Mays, PhD, MPH, MS International Heart Institute of Montana Foundation

Additional Information:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02280200     History of Changes
Other Study ID Numbers: Mays-2
U54GM104944 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
claudication
ankle foot orthoses
community walking exercise

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases