Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis

NCT02902211 | Completed Results FDA Device

• 1 other identifier: 0485-16-FB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This study will determine whether an ankle foot orthosis (AFO) improves walking performance in participants 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 participants 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 to fit 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.

Conditions

Peripheral Artery Disease

Keywords

ankle foot orthosis; biomechanics; mobility

Outcome Measures

Primary Outcomes (1)

• Maximum Walking Time From the Gardner Graded Treadmill Protocol

  Change in Initial claudication and the absolute claudication time from the progressive treadmill test when walking with ankle foot orthoses (AFO)

  After three months of intervention with the ankle foot orthosis.

Study Arms (2)

Ankle foot orthosis

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Ankle foot orthosis DEVICE

Patients will wear an ankle foot orthosis at all times except when he/she is sleeping or bathing for three months.

Ankle foot orthosis

Control/standard of care OTHER

Patients will carry out with typical activities suggested by their physician for three months.

Control

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (2)

Omaha VA Medical Center

Omaha, Nebraska, 68105, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• Bashir AZ, Dinkel DM, Pipinos II, Estabrooks PA, Johanning JM, Myers SA. Long-term use of an ankle-foot orthosis intervention in patients with peripheral artery disease using the integrated promoting action on research implementation in health services (i-PARIHS) framework. Int J Cardiol. 2023 Feb 1;372:23-32. doi: 10.1016/j.ijcard.2022.11.041. Epub 2022 Nov 29.

  PMID: 36455699 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Sara Myers
• Organization: University of Nebraskat at Omaha

samyers@unomaha.edu

402-554-3246

Study Officials

• Sara A Myers, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 15, 2016
• Study Start: July 7, 2017
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for five years upon the completion of the study.
• Access Criteria: contact PI, samyers@unomaha.edu

Locations

US (2)