No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 90
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for veterans who have had a stroke and want to improve their walking and balance. Participants will take part in training sessions focused on backward walking and undergo brain activity scans before and after the training.
Are You a Good Fit for This Trial?
You may be able to join if
I have a Berg Balance Scale score of less than 45.
I can walk at a speed of less than 0.8 m/s over 10 meters.
I was diagnosed with a unilateral stroke.
It has been more than 2 months and less than 4 months since my stroke.
I can walk at least 10 feet with the help of one person.
I am medically stable.
You may not be able to join if
I have a neurological condition other than stroke.
I have had serious heart issues recently.
I have severe arthritis or orthopedic problems affecting my legs.
I have severe high blood pressure at rest.
I experience pain when walking.
I am receiving physical therapy for mobility or walking.
I live in a skilled nursing facility.
I cannot have an MRI due to metal implants or claustrophobia.
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.
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. The investigators have previously established the effectiveness of a backward walking training program to improve gait and balance in post-stroke Veterans. To bes…
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. The investigators have previously established the effectiveness of a backward walking training program to improve gait and balance in post-stroke Veterans. To best serve Veterans in this era of personalized medicine, there is a current need to determine the appropriate training dose as well as which post-stroke Veterans would most benefit. This study addresses both needs as it will 1) test responses to two different doses (18 vs. 27 sessions) of backward walking training and 2) assess brain activity, measured by magnetic resonance imaging, before and after training intervention to determine its ability to predict rehabilitation response as well as brain mechanisms of behavioral change.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Berg Balance Scale \< 45
* Self-selected 10 meter gait speed \< 0.8 m/s
* Diagnosis of unilateral stroke
* \> 2 months \< 4 months post-stroke
* Able to ambulate at least 10 feet with maximum 1 person assist
* Medically stable
Exclusion Criteria:
* Presence of neurological c…
Inclusion Criteria:
* Berg Balance Scale \< 45
* Self-selected 10 meter gait speed \< 0.8 m/s
* Diagnosis of unilateral stroke
* \> 2 months \< 4 months post-stroke
* Able to ambulate at least 10 feet with maximum 1 person assist
* Medically stable
Exclusion Criteria:
* Presence of neurological condition other than stroke
* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
* Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded
* Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10 degrees, knee flexion ROM \< 90 degrees, hip flexion contracture \> 25 degrees, and ankle plantar flexion contracture \> 15 degrees)
* Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest
* Pain upon ambulation
* Receiving physical therapy services for mobility and/or gait
* Living in a skilled nursing facility
* Any MRI contraindication, including but not limited to the presence of metal, MR sensitive implanted medical devices, or claustrophobia
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