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Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis

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ClinicalTrials.gov Identifier: NCT02902211
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Sara A Myers, University of Nebraska

Brief Summary:

This study will determine whether an ankle foot orthosis (AFO) improves walking performance in patients with PAD from its first use. Additionally, the study will test walking performance after a three month AFO intervention and will examine the feasibility of this AFO intervention.

Data for evaluations will be collected from 50 patients with PAD. Fifty healthy age-matched controls will be participate in one baseline gait assessment for comparison purposes. Both groups between 40-85 years old.

Interventions and Evaluations Biomechanics evaluations: Patients with PAD will complete a biomechanics evaluation at baseline, following three months of control (standard of care), and following three months of AFO intervention. The evaluation will include measurement of walking distances, gait function, physical activity, quality of life, energy cost, muscle morphometrics, muscle activity, muscle oxygenation, and muscle strength and endurance while walking with and without the AFO. Healthy controls will be assessed during one baseline collection only and their participation in the study will then be finished.

Feasibility interview: All patients with PAD will participate in feasibility interviews that will assess acceptability, demand, implementation, and practicality. Interviews will occur 1.5 months and following completion of the AFO intervention (not the control arm).

AFO and Control (standard of care) Intervention: Patients will wear an off-the-shelf, carbon composite AFO that is adjusted for them for three months. The patients will be asked to wear the AFO at all times except when they are in bed or showering/bathing. The instructions given to the patients about walking will be to follow the instructions from their doctor regarding risk factor management and exercise. The intervention order will be randomized and all subjects will participate in both arms.


Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: Ankle foot orthosis Other: Control/standard of care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ankle foot orthosis
Patients will wear an off-the-shelf, carbon composite AFO that is adjusted for them for three months. The patients will be asked to wear the AFO at all times except when they are in bed or showering/bathing. The instructions given to the patients about walking will be to follow the instructions from their doctor regarding risk factor management and exercise.
Device: Ankle foot orthosis
Patients will wear an ankle foot orthosis at all times except when he/she is sleeping or bathing for three months.

Active Comparator: Control
Patients will be asked to follow the instructions from their doctor regarding risk factor management and exercise for three months.
Other: Control/standard of care
Patients will carry out with typical activities suggested by their physician for three months.




Primary Outcome Measures :
  1. Maximum walking distance from the Gardner graded treadmill protocol. [ Time Frame: Three months after intervention with the ankle foot orthosis. ]
    Initial claudication distance and the absolute claudication distance from the progressive treadmill test



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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • able to give written, informed consent
  • demonstrate positive history of chronic claudication
  • demonstrate exercise limiting claudication established by history and direct observation
  • 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:

  • rest pain or tissue loss due to PAD (Fontaine stage III and IV)2)
  • acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma
  • walking capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology

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): NCT02902211


Contacts
Contact: Holly DeSpiegelaere, RN 402-995-4171 Holly.DeSpiegelaere@va.gov
Contact: Mahdi Hassan, MS 402-554-4186 mhassan2@unomaha.edu

Locations
United States, Nebraska
Omaha VA Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Contact: Holly Despiegelaere, RN    402-995-4171    Holly.DeSpiegelaere@va.gov   
Principal Investigator: Sara Myers, PhD         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Sara A Myers, PhD University of Nebraska, Omaha

Responsible Party: Sara A Myers, Associate Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT02902211     History of Changes
Other Study ID Numbers: 485-16-FB
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Sara A Myers, University of Nebraska:
ankle foot orthosis
biomechanics
mobility

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