The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
408
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.
Centinela Freeman Memorial Hospital
Inglewood, California, United States
Long Beach Memorial Hospital
Long Beach, California, United States
University of Southern California - PT Associates
Los Angeles, California, United States
Sharp Memorial Rehabilitation Center
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.
Time frame: 12 months post-stroke
Walking Speed: Measured During a 10-meter Walk
Time frame: Baseline and 12 months post-stroke
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.
Time frame: Baseline and 6 months post-stroke
6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
Time frame: Baseline and 6 months post-stroke
6 Minute Walking Distance (Meters)
Distance walked in 6 minutes.
Time frame: 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.
Time frame: 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.
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San Diego, California, United States
University of Florida
Gainesville, Florida, United States
Brooks Rehabilitation Hospital
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Duke University (Administrative Coordinating Center)
Durham, North Carolina, United States
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6 months and 12 months post-stroke