Locomotor Experience Applied Post Stroke (LEAPS) Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 408
- Locations
- 8
- Primary Endpoint
- Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke
Study Overview
Brief Summary
The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).
Detailed Description
The impact of stroke on walking is significant, with only 37 percent of stroke survivors able to walk after the first week after stroke (or post-stroke). Even among those who achieve independent ambulation, significant residual deficits persist in balance and gait speed with a 73 percent incidence of falls among individuals with mild to moderate impairment 6 months post-stroke. Body weight supported treadmill training is one therapeutic method for locomotor training that is rapidly being adopted into physical rehabilitation to improve walking after stroke.
The purpose of this multi-center, randomized controlled study is to compare two different treatments to improve walking after stroke. The two treatments are: 1) a training program that includes use of a body weight support system and a treadmill to practice walking and 2) a physical therapist monitored exercise program to work on general conditioning and strengthening in the patient's home. In addition, investigators will determine the best time to provide training after a stroke and if the training is beneficial for mild, moderate, or severe cases of stroke.
Four hundred subjects will be recruited from five facilities in Florida and California. Screening and subject recruitment will take place within 45 days post-stroke. All stroke patients will be screened to determine eligibility for the study. Eligible subjects will be followed for 2 months post-stroke. At that time, those who are eligible for enrollment and who consent to participate will undergo an exercise tolerance test and baseline assessment. Following this evaluation, participants will be randomized into one of three groups, according to the severity of their locomotor impairment: early locomotor, late locomotor, or early home exercise.
The early locomotor training group will begin the locomotor training program immediately (2 months post stroke). The 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. The late locomotor training group will begin locomotor training at 6 months post-stroke. Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning immediately (2 months post stroke).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Early Locomotor Training Program
body weight supported training program with treadmill
Intervention: Early locomotor training program (Behavioral)
Early Home Exercise Program
a non-specific low intensity exercise program
Intervention: Home Exercise Program (Behavioral)
Late Locomotor Training Program
body weight supported training program with treadmill
Intervention: Late locomotor training program (Behavioral)
Outcomes
Primary Outcomes
Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke
Time Frame: 12 months post-stroke
Success: walking greater than 0.4 m/sec if baseline was less than 0.4; walking greater than 0.8 m/sec if baseline was 0.4m/sec or greater but less than 0.8 m/sec as measured during 10 meter walk.
Walking Speed: Measured During a 10-meter Walk
Time Frame: Baseline and 12 months post-stroke
Secondary Outcomes
- 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk(Baseline and 6 months post-stroke)
- Stroke Impact Scale (SIS) - Mobility(Baseline, 6 months and 12 months post-stroke)
- Fugl-Meyer Lower Extremity Score(Baseline, 6 months and 12 months post-stroke)
- Stroke Impact Scale (SIS) - Participation(Baseline, 6 months and 12 months post-stroke)
- Berg Balance Score(Baseline, 6 months and 12 months post-stroke)
- 6 Minute Walking Distance (Meters)(Baseline, 6 months and 12 months post-stroke)
- Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke(Baseline and 6 months post-stroke)
- Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day(Baseline, 6 months and 12 months post-stroke)
- Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)(Baseline, 6 months and 12 months post-stroke)
- Activities Specific Balance Confidence (ABC) Score(Baseline, 6 months and 12 months post-stroke)