No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
University of Texas at Austin · Other
Who this trial is looking for
This trial is looking for adults who are at least three months post-stroke and have lower-limb impairment. Participants will wear three different ankle-foot orthosis designs over a month and answer questions about their experiences.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least three months post-stroke
I am over 18 years old
I have been prescribed a semi-rigid or custom-made AFO
I wear my AFO for all mobility outside my home
I can walk at least 20 meters without help
I can walk at least 10 meters per minute
You may not be able to join if
I have a condition that limits my ability to walk
I have severe osteoarthritis or rheumatoid arthritis
I have congestive heart failure
I have a neurological disorder other than post-stroke
I have cognitive issues that prevent me from giving consent
I have an ankle contracture of 15 degrees or more
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The overall goal of this study is to attain the highest possible health-related quality of life for individuals with lower-limb impairment through a clinical trial examining three different modern carbon fiber ankle-foot orthosis (AFO) treatment options targeting the rehabilitation of individuals post-stroke. To achieve this goal, the investigators will:
1. Identify the factors that significantly…
The overall goal of this study is to attain the highest possible health-related quality of life for individuals with lower-limb impairment through a clinical trial examining three different modern carbon fiber ankle-foot orthosis (AFO) treatment options targeting the rehabilitation of individuals post-stroke. To achieve this goal, the investigators will:
1. Identify the factors that significantly contribute to an individual's highest potential quality of life when considering each of the three available AFO design options, and
2. Develop prediction models of clinical performance using biomechanical function linked to the three AFO designs.
Participants will be asked to:
* Wear each of the three modern AFO designs for one month, after receiving therapy training and
* Complete questionnaires and performance tests with each AFO.
In addition, the subset of individuals participating in goal 2) will also be asked to:
* Perform biomechanical analyses using high-speed cameras and force plates during different walking and balance tests with each AFO design.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* be a minimum of three months post-stroke
* be greater than 18 years of age
* have been prescribed either a semi-rigid or a custom-made articulating AFO
* wear their prescribed AFO for all primary mobility activity outside the house
* be able to walk at least 20 meters without …
Inclusion Criteria:
* be a minimum of three months post-stroke
* be greater than 18 years of age
* have been prescribed either a semi-rigid or a custom-made articulating AFO
* wear their prescribed AFO for all primary mobility activity outside the house
* be able to walk at least 20 meters without manual assistance
* walk at least 10 meters per minute (12% of normal velocity) during a 6-meter self-selected velocity walking test.
Exclusion Criteria:
* having a condition that could significantly limit ambulation, including severe osteoarthritis, rheumatoid arthritis, congestive heart failure, or pre-existing neurological disorder other than post-stroke
* having cognitive deficits that preclude their ability to provide consent for participation
* having an ankle plantar flexion contracture equal to or greater than 15 degrees plantar flexion with full knee extension
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