Locomotor Experience Applied Post Stroke Trial
Condition: Stroke
MeSH terms: Stroke
Intervention: Early locomotor training program; Late locomotor training program; Home Exercise Program
Intervention description: The early locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 2 months post-stroke.; The late locomotor training program is an out-patient program of locomotor training for 36 sessions, 3 times per week, using a body weight support system and stepping on a treadmill and overground training beginning at 6 months post-stroke.; Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 408.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stroke; locomotor; exercise; walking; training program; body weight support training; physical therapy

Summary:

      The purpose of this study is to compare two different treatments to improve walking after
      stroke (or post-stroke).
    

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