LEAPS
Locomotor Experience Applied Post Stroke Trial
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Purpose:
To determine when it is best to begin physical therapy and the effectiveness of particular interventions in reducing walking disabilities following a stroke.
Interventions:
Robotic Aids
This category includes any mechanical and/or computerized device designed to improve extremity function.
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Location(s):
California, Florida and North Carolina.
Year Started:
2006
Design:
Multi-center, treatment, randomized, open label trial.
Inclusion Criteria
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, self selected 10 meter gait speed less than 0.8 m/s, 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 (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; 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 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 ( PHQ-9 >/= 10); history of deep venous thrombosis or 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).
Patient Involvement:
Patients will be randomized into one of three groups: early locomotor (beginning at 2 months post-stroke), late locomotor (beginning at 6 months post-stroke), or early home exercise (beginning at 2 months post-stroke). The locomotor groups will utilize a body weight support system and a treadmill and the home exercise group will receive non-specific low intensity exercise training. All three groups will train for 12 weeks, 3 times per week to complete a total of 36 sessions.
Primary Outcome:
Gait speed: measured during a 10-meter walk; Success: walking greater than 0.4 m/sec if baseline was 0.4; walking greater than 0.8 m/sec if baseline was. 4m/sec or greater but less 0.8 m/sec.
Secondary Outcome:
The distance a person can walk; the amount of daily walking that a person is willing and able to do.
Source of Information:
Clinicaltrials.gov
Presented at the 2008 International Stroke Conference (February 2008).
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This information last updated on: 3/24/2009
Reviewed on: 06/16/2009.
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