No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
30 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
156 (estimated)
Sponsor
University of Cincinnati · Other
Who this trial is looking for
This trial is looking for people who had a stroke at least 6 months ago and still have trouble walking. Participants will do walking exercises with a physical therapist for 12 weeks, three times a week.
Are You a Good Fit for This Trial?
Rules you outSevere arrhythmiaMajor depression
You may be able to join if
I am between 30 and 85 years old.
I have weakness on one side of my body due to a stroke.
My last stroke was at least 6 months ago.
My walking speed is slower than 1.0 m/s.
I can walk 10 meters with some help but not continuous assistance.
I can walk on a treadmill for at least 3 minutes.
I have a stable heart condition.
I can understand and answer questions from the research team.
You may not be able to join if
I have serious heart issues that affect exercise tests.
I have been hospitalized for heart or lung problems in the last 3 months.
I have a pacemaker or defibrillator that limits my exercise.
I have severe balance issues or instability in my legs.
I have used drugs or had mental health problems recently.
I have major depression that isn't being treated.
I am already in therapy or another trial for walking problems.
I was unable to walk outside my home before my stroke.
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.
People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of tr…
People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 30-85 years at time of consenting
* Hemiparesis from ischemic and/or hemorrhagic strokes
* Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
* Walking speed \<1.0 m/s on the 10-meter walk test
* Able to walk 10m over ground…
Inclusion Criteria:
* Age 30-85 years at time of consenting
* Hemiparesis from ischemic and/or hemorrhagic strokes
* Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
* Walking speed \<1.0 m/s on the 10-meter walk test
* Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
* Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
* Stable cardiovascular condition (AHA class B, allowing for aerobic capacity \<6 metabolic equivalents)
* Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
Exclusion Criteria:
* Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these conditions)
* Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
* Hospitalization for cardiac or pulmonary disease within past 3 months
* Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
* Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
* Severe lower limb spasticity (Ashworth \>2)
* Known recent history (\<3 months) of unstable substance abuse or unstable mental illness
* Major post-stroke depression (Patient Health Questionnaire \[PHQ-9\] ≥ 10) in the absence of depression management by a health care provider
* Currently participating in physical therapy or another interventional study targeting walking function
* Recent (\<2 weeks) or planned changes in lower limb orthotic or spasticity management
* Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
* Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
* Unable to walk outside the home prior to stroke
* Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
* Pregnancy
* Previous exposure to fast treadmill walking (\>3 cumulative hours) in the past year
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