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N/A N=33 Randomized Treatment

Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis

Peripheral Artery Disease

Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Maximum Walking Time From the Gardner Graded Treadmill Protocol — 117.7; 197.5; 188; 339.9 Seconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Ankle foot orthosis (Device); Control/standard of care (Other)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
University of Nebraska
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Walking Time From the Gardner Graded Treadmill Protocol
117.7; 197.5; 188; 339.9

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02902211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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