Locomotor Experience Applied Post Stroke Trial "LEAPS"


Phase 3 Results

Eligibility Criteria

Inclusion Criteria

- Age >/=18
- Stroke within 45-days
- Residual paresis in the lower extremity (fugl-meyer le motor score < 34)
- Ability to sit unsupported for 30 seconds
- Ability to walk at least 10 feet with maximum 1 person assist
- Ability to follow a three step command
- Provision of informed consent
- A self-selected 10 meter gait speed less than 0.8 m/s at the 2-month post-stroke assessment
- Successful completion of an exercise tolerance test

Exclusion Criteria

- Lived in nursing home prior to stroke
- Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking less than 200 meters
- Serious cardiac conditions (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
- History of serious chronic obstructive pulmonary disease or oxygen dependence
- Severe weight bearing pain
- Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, or previous stroke with residual neurological deficits
- History of major head trauma
- Lower extremity amputation
- Non-healing ulcers on the lower extremity
- Renal dialysis or end stage liver disease
- Legal blindness or severe visual impairment
- A history of significant psychiatric illness defined by diagnosis of bipolar affective disorder, psychosis, schizophrenia or medication refractory depression
- Life expectancy less than one year
- Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10°, knee flexion Range of Motion (ROM) < 90°, hip flexion contracture > 25°, and ankle plantar flexion contracture > 15°
- History of sustained alcoholism or drug abuse in the last six months
- Major post-stroke depression as measured by the Patient Health Questionnaire(PHQ-9 >/= 10) that is not medically managed with antidepressant medication and/or psychotherapy
- History of pulmonary embolism within 6 months
- Uncontrollable diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest,
- Previous or current enrollment in a clinical trial to enhance stroke motor recovery
- Lives more than 50 miles from the training sites
- Unable to travel 3 times per week for outpatient training programs
- Intracranial hemorrhage related to aneurysmal rupture or an arteriovenous malformation (hemorrhagic infarctions will not be excluded)
Inclusion and exclusion criteria will be determined by a chart review, depression screen and subject interview by study physician or study coordinator. After initial chart and subject interview, each subject's treating physician will be asked to review inclusion and exclusion criteria and provide a letter supporting inclusion in the study. All subjects who meet selection criteria must successfully complete an exercise tolerance test