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NCT02902211 · ClinicalTrials.gov registry record · NA
Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis
A NA study, sponsored by University of Nebraska.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT02902211 is a NA study that has completed, run by University of Nebraska. The registered enrollment target is 50 participants.
The verdict
NCT02902211, a NA study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Ankle foot orthosis
- OTHER Control/standard of care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-07-07 |
| Est. Completion | 2023-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02902211
The ClinicalTrials.gov registry entry for NCT02902211 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ankle foot orthosis is the first listed.
NCT02902211 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02902211 about?
NCT02902211 is a clinical study titled "Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis". 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 eva...
What is the current status of trial NCT02902211?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2017-07-07. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT02902211?
The interventions under investigation include: Ankle foot orthosis (DEVICE), Control/standard of care (OTHER).
Who is sponsoring clinical trial NCT02902211?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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