Locomotor Experience Applied Post Stroke Trial

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

Detailed Description
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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).

Official Title
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Locomotor Experience Applied Post Stroke (LEAPS) Trial

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Early locomotor training program
* Behavioral: Late locomotor training program
* Behavioral: Home Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Locomotor Training Program<br>body weight supported training program with treadmill | Behavioral: Early locomotor training program<br>* 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.<br>* Other names: LTP-early;|
| Active Comparator: Late Locomotor Training Program<br>body weight supported training program with treadmill | Behavioral: Late locomotor training program<br>* 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.<br>* Other names: LTP-late;|
| Active Comparator: Early Home Exercise Program<br>a non-specific low intensity exercise program | Behavioral: Home Exercise Program<br>* Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.<br>* Other names: HEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year 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. | 12 months post-stroke | 
| Walking Speed: Measured During a 10-meter Walk |  | Baseline and 12 months post-stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 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. | Baseline and 6 months post-stroke | 
| 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk |  | Baseline and 6 months post-stroke | 
| 6 Minute Walking Distance (Meters) | Distance walked in 6 minutes. | Baseline, 6 months and 12 months post-stroke | 
| Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | As measured with a step activity monitor averaged over 2 days. | Baseline, 6 months and 12 months post-stroke | 
| Stroke Impact Scale (SIS) - Participation | Range = 0 - 100. The Stroke Impact Scale is a measure of function (including ADL-IADL and mobility) and quality of life (participation). The Participation Scale is a single domain of the Stroke Impact Scale in which participation is defined as the ability to engage in meaningful activities with 0 indicating inability to engage in any meaningful activities and 100 indicating the ability to fully engage in meaningful activities. | Baseline, 6 months and 12 months post-stroke | 
| Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | Range 0 - 100 The Stroke Impact Scale (SIS) is a measure of function including ADL/IADL. The ADL/IADL scale is a single domain of the Stroke Impact Scale in which ADL is defined as the ability to take care of basic needs and IADL is defined as the ability to perform activities that make it possible to live independently in the community, with 0 indicating complete dependence on others and 100 indicating the ability to live independently without difficulty. | Baseline, 6 months and 12 months post-stroke | 
| Stroke Impact Scale (SIS) - Mobility | Range = 0 - 100. The Stroke Impact Scale (SIS) is a measure of function including Mobility. The Mobility scale is a single domain of the Stroke Impact Scale which captures the ability to balance and move, with 0 indicating severe restrictions in balance and mobility and 100 indicating independence in mobility and balance. | Baseline, 6 months and 12 months post-stroke | 
| Fugl-Meyer Lower Extremity Score | Range 0 - 34 The Fugl-Meyer Lower Extremity Score measures your ability to move the lower extremity with 0 indicating no movement and 34 indicating the ability to selectively move the lower extremity without difficulty. | Baseline, 6 months and 12 months post-stroke | 
| Berg Balance Score | Range = 0 - 56 The Berg Balance Score assesses balance in sitting, standing, reaching, shifting weight and turning, with 0 defined as inability to balance and 56 defined as the ability to balance independently and without difficulty while performing each task. | Baseline, 6 months and 12 months post-stroke | 
| Activities Specific Balance Confidence (ABC) Score | Range = 0 - 100 The ABC scale is a self reported measure of confidence with activities such as walking around the house, standing on a chair to reach or getting out of a car without losing balance or becoming unsteady. A score of 0 indicates no confidence that the activities can be performed without losing balance and a score 100 indicates confidence that the activities can be accomplished without losing balance. | Baseline, 6 months and 12 months post-stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body weight support training, stroke, locomotor, exercise, walking, training program, physical therapy