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
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|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
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
|Contact: Holly DeSpiegelaere, RN||402-995-4171||Holly.DeSpiegelaere@va.gov|
|Contact: Mahdi Hassan, MSfirstname.lastname@example.org|
|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|
|Principal Investigator:||Sara A Myers, PhD||University of Nebraska, Omaha|