A Study to Compare the Gait when Using an Ankle Foot Orthosis versus no Ankle Foot Orthosis in People with Sub-Acute to Chronic Hemiplegia Secondary to Stroke
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-009089
Sponsor Protocol Number: 16-009089
About this study
The purpose of this study is to examine the gait in patients with hemiplegia following a stroke, when wearing an ankle foot orthosis and without wearing an ankle foot orthosis.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with sub-acute (greater than 1 month) to chronic stroke with cerebral hemorrhage or ischemia in either hemisphere.
- Should be able to ambulate for 6 minutes on level surfaces continuously without physical assistance, with and without an AFO.
- Will be able to use their preferred assistive device as necessary. Subjects 18 years of age or older.
- Patients must be able to follow a simple 2 step verbal instructions
Exclusion Criteria:
- Patients who are unable to understand the testing procedure due to a receptive aphasia, acute orthopedic injuries
- Inability to ambulate for 6 minutes without an ankle foot orthosis
- Patients with other neurologic conditions that may limit gait ability separate from stroke will be excluded
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bryce Beckman, P.T., D.P.T., NCS |
Closed for enrollment |
|
More information
Publications
Publications are currently not available