Stroke
Conditions
Keywords
stroke, locomotor, exercise, walking, training program, body weight support training, physical therapy
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).
Interventions
BEHAVIORALEarly locomotor training program
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.
BEHAVIORALLate locomotor training program
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.
BEHAVIORALHome Exercise Program
Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke | 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 | Baseline and 12 months post-stroke | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walking Distance (Meters) | Baseline, 6 months and 12 months post-stroke | Distance walked in 6 minutes. |
| Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | Baseline, 6 months and 12 months post-stroke | As measured with a step activity monitor averaged over 2 days. |
| Stroke Impact Scale (SIS) - Participation | Baseline, 6 months and 12 months post-stroke | 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. |
| Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | Baseline, 6 months and 12 months post-stroke | 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. |
| Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke | Baseline and 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. |
| Fugl-Meyer Lower Extremity Score | Baseline, 6 months and 12 months post-stroke | 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. |
| Berg Balance Score | Baseline, 6 months and 12 months post-stroke | 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. |
| Activities Specific Balance Confidence (ABC) Score | Baseline, 6 months and 12 months post-stroke | 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. |
| Stroke Impact Scale (SIS) - Mobility | Baseline, 6 months and 12 months post-stroke | 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. |
| 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk | Baseline and 6 months post-stroke | — |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 6 inpatient rehabilitation centers in California and Florida from April 2006 through June 2009.
Pre-assignment details
Participants admitted for inpatient rehabilitation were screened by chart review. Eligible participants with first-time stroke received a comprehensive medical record review and physical and cognitive screening. At 2-months, those who maintained eligibility and successfully completed an exercise tolerance test were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Early Locomotor Training Program Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke. | 139 |
| Late Locomotor Training Program Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke. | 143 |
| Home Exercise Program HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke. | 126 |
| Total | 408 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative Error | 1 | 0 | 0 |
| Overall Study | Death | 3 | 4 | 6 |
| Overall Study | Lost to Follow-up | 6 | 7 | 3 |
| Overall Study | Physician Decision | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 6 | 2 |
Baseline characteristics
| Characteristic | Late Locomotor Training Program | Total | Home Exercise Program | Early Locomotor Training Program |
|---|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 12.5 | 62.0 years STANDARD_DEVIATION 12.7 | 62.6 years STANDARD_DEVIATION 13.3 | 60.1 years STANDARD_DEVIATION 12.3 |
| Comfortable walking speed (m/sec) | 0.38 m/sec STANDARD_DEVIATION 0.23 | 0.38 m/sec STANDARD_DEVIATION 0.22 | 0.39 m/sec STANDARD_DEVIATION 0.22 | 0.36 m/sec STANDARD_DEVIATION 0.22 |
| Comorbidities Arthritis/other musculoskeletal | 52 participants | 146 participants | 47 participants | 47 participants |
| Comorbidities Cardiovascular | 36 participants | 109 participants | 37 participants | 36 participants |
| Comorbidities Chronic Obstructive Pulmonary Disease (COPD) | 14 participants | 26 participants | 7 participants | 5 participants |
| Comorbidities Depression (Personal Health Questionnaire-9 >= 10) | 28 participants | 67 participants | 19 participants | 20 participants |
| Comorbidities Diabetes | 51 participants | 141 participants | 43 participants | 47 participants |
| Comorbidities Hypertension | 111 participants | 331 participants | 104 participants | 116 participants |
| Comorbidities Peripheral vascular disease | 12 participants | 37 participants | 13 participants | 12 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 63 Participants | 22 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants | 345 Participants | 104 Participants | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Mini Mental Status Exam | 26.2 scores on a scale STANDARD_DEVIATION 3.7 | 26.1 scores on a scale STANDARD_DEVIATION 3.5 | 26.0 scores on a scale STANDARD_DEVIATION 3.6 | 26.0 scores on a scale STANDARD_DEVIATION 3.2 |
| Modified Rankin Scale Rankin 0 - 1 (no significant disability) | 2 participants | 2 participants | 0 participants | 0 participants |
| Modified Rankin Scale Rankin 2 (slight disability) | 21 participants | 54 participants | 21 participants | 12 participants |
| Modified Rankin Scale Rankin 3 (moderate disability) | 57 participants | 172 participants | 49 participants | 66 participants |
| Modified Rankin Scale Rankin 4 (moderately severe disability) | 63 participants | 180 participants | 56 participants | 61 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 5 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 54 Participants | 15 Participants | 19 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 90 Participants | 24 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 9 Participants | 19 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 77 Participants | 236 Participants | 78 Participants | 81 Participants |
| Sex: Female, Male Female | 69 Participants | 184 Participants | 61 Participants | 54 Participants |
| Sex: Female, Male Male | 74 Participants | 224 Participants | 65 Participants | 85 Participants |
| Side of involvement Left Hemiparesis | 58 participants | 182 participants | 61 participants | 63 participants |
| Side of involvement Right Hemiparesis | 85 participants | 226 participants | 65 participants | 76 participants |
| Stroke Type Hemorrhage | 22 participants | 70 participants | 21 participants | 27 participants |
| Stroke Type Lacune | 45 participants | 128 participants | 43 participants | 40 participants |
| Stroke Type Large Vessel | 60 participants | 162 participants | 47 participants | 55 participants |
| Stroke Type Undefined | 16 participants | 48 participants | 15 participants | 17 participants |
| Time since stroke to randomization - days | 64.18 days STANDARD_DEVIATION 9 | 63.8 days STANDARD_DEVIATION 8.5 | 62.9 days STANDARD_DEVIATION 8 | 64.1 days STANDARD_DEVIATION 8.3 |
| Walking Speed (m/sec) Moderate Disability (0.4 - 0.8 m/sec) | 66 participants | 190 participants | 60 participants | 64 participants |
| Walking Speed (m/sec) Severe Disability (<0.4 m/sec) | 77 participants | 218 participants | 66 participants | 75 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 100 / 139 | 101 / 143 | 88 / 126 |
| serious Total, serious adverse events | 51 / 139 | 59 / 143 | 39 / 126 |
Outcome results
Primary
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
Population: Intention to treat analysis. Missing data were imputed using the LOCF method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Locomotor Training Program | Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke | 50.4 percent of participants |
| Late Locomotor Training Program | Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke | 53.8 percent of participants |
| Home Exercise Program | Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke | 51.6 percent of participants |
Comparison: Logistic regression was used to compare the proportion of participants who improved functional level of walking between Early-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression). Assuming that 30% of HEP participants would improve functional level of walking, we derived a sample size of 400 to detect a clinically relevant 20% effect size with 85% power, adjusting for an loss-to-follow-up rate of 15%.p-value: 0.48195% CI: [0.497, 1.391]Regression, Logistic
Comparison: Logistic regression was used to compare the proportion of participants who improved functional level of walking between Late-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).p-value: 0.50195% CI: [0.715, 1.985]Regression, Logistic
Primary
Walking Speed: Measured During a 10-meter Walk
Time frame: Baseline and 12 months post-stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Locomotor Training Program | Walking Speed: Measured During a 10-meter Walk | Baseline | 0.37 m/sec | Standard Deviation 0.22 |
| Early Locomotor Training Program | Walking Speed: Measured During a 10-meter Walk | 12-month change from Baseline | 0.23 m/sec | Standard Deviation 0.2 |
| Late Locomotor Training Program | Walking Speed: Measured During a 10-meter Walk | Baseline | 0.38 m/sec | Standard Deviation 0.23 |
| Late Locomotor Training Program | Walking Speed: Measured During a 10-meter Walk | 12-month change from Baseline | 0.24 m/sec | Standard Deviation 0.23 |
| Home Exercise Program | Walking Speed: Measured During a 10-meter Walk | Baseline | 0.39 m/sec | Standard Deviation 0.22 |
| Home Exercise Program | Walking Speed: Measured During a 10-meter Walk | 12-month change from Baseline | 0.25 m/sec | Standard Deviation 0.22 |
Comparison: The second primary analysis assessed the timing effect and its interaction with initial severity of gait impairment on walking speed change from baseline to 1 year after stroke.p-value: 0.242Regression, Linear
Secondary
6 Minute Walking Distance (Meters)
Distance walked in 6 minutes.
Time frame: Baseline, 6 months and 12 months post-stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Locomotor Training Program | 6 Minute Walking Distance (Meters) | Baseline | 124.1 meters | Standard Deviation 77.5 |
| Early Locomotor Training Program | 6 Minute Walking Distance (Meters) | 6-month change from baseline | 81.8 meters | Standard Deviation 62.8 |
| Early Locomotor Training Program | 6 Minute Walking Distance (Meters) | 12-month change from baseline | 73.2 meters | Standard Deviation 69.4 |
| Late Locomotor Training Program | 6 Minute Walking Distance (Meters) | 12-month change from baseline | 79.0 meters | Standard Deviation 75.1 |
| Late Locomotor Training Program | 6 Minute Walking Distance (Meters) | 6-month change from baseline | 41.0 meters | Standard Deviation 47.4 |
| Late Locomotor Training Program | 6 Minute Walking Distance (Meters) | Baseline | 125.7 meters | Standard Deviation 81.8 |
| Home Exercise Program | 6 Minute Walking Distance (Meters) | 12-month change from baseline | 85.2 meters | Standard Deviation 72.9 |
| Home Exercise Program | 6 Minute Walking Distance (Meters) | 6-month change from baseline | 75.9 meters | Standard Deviation 69.3 |
| Home Exercise Program | 6 Minute Walking Distance (Meters) | Baseline | 126.3 meters | Standard Deviation 75 |
Comparison: Primary 12 month analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.45ANOVA
Comparison: 6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: <0.001ANOVA
Secondary
6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
Time frame: Baseline and 6 months post-stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Locomotor Training Program | 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk | Baseline | 0.37 m/sec | Standard Deviation 0.22 |
| Early Locomotor Training Program | 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk | 6 month change from Baseline | 0.25 m/sec | Standard Deviation 0.21 |
| Late Locomotor Training Program | 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk | Baseline | 0.38 m/sec | Standard Deviation 0.23 |
| Late Locomotor Training Program | 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk | 6 month change from Baseline | 0.13 m/sec | Standard Deviation 0.14 |
| Home Exercise Program | 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk | Baseline | 0.39 m/sec | Standard Deviation 0.22 |
| Home Exercise Program | 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk | 6 month change from Baseline | 0.23 m/sec | Standard Deviation 0.2 |
Comparison: 6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between early-LTP and late-LTP.p-value: <0.000195% CI: [0.08, 0.16]t-test, 2 sided
Comparison: 6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between HEP and late-LTP.p-value: <0.000195% CI: [0.05, 0.14]t-test, 2 sided
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Locomotor Training Program | Activities Specific Balance Confidence (ABC) Score | 6-month change from Baseline | 13.8 units on a scale | Standard Deviation 20.8 |
| Early Locomotor Training Program | Activities Specific Balance Confidence (ABC) Score | Baseline | 43.6 units on a scale | Standard Deviation 23.5 |
| Early Locomotor Training Program | Activities Specific Balance Confidence (ABC) Score | 12-month change from Baseline | 11.2 units on a scale | Standard Deviation 22.3 |
| Late Locomotor Training Program | Activities Specific Balance Confidence (ABC) Score | 6-month change from Baseline | 6.2 units on a scale | Standard Deviation 20.2 |
| Late Locomotor Training Program | Activities Specific Balance Confidence (ABC) Score | Baseline | 47.0 units on a scale | Standard Deviation 25.4 |
| Late Locomotor Training Program | Activities Specific Balance Confidence (ABC) Score | 12-month change from Baseline | 11.7 units on a scale | Standard Deviation 22.1 |
| Home Exercise Program | Activities Specific Balance Confidence (ABC) Score | Baseline | 44.5 units on a scale | Standard Deviation 22.6 |
| Home Exercise Program | Activities Specific Balance Confidence (ABC) Score | 12-month change from Baseline | 13.9 units on a scale | Standard Deviation 21.7 |
| Home Exercise Program | Activities Specific Balance Confidence (ABC) Score | 6-month change from Baseline | 15.6 units on a scale | Standard Deviation 19.4 |
Comparison: 12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.62ANOVA
Comparison: 6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: <0.001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Locomotor Training Program | Berg Balance Score | 6-month change from Baseline | 8.8 units on a scale | Standard Deviation 8.1 |
| Early Locomotor Training Program | Berg Balance Score | Baseline | 35.0 units on a scale | Standard Deviation 14.4 |
| Early Locomotor Training Program | Berg Balance Score | 12-month change from Baseline | 8.0 units on a scale | Standard Deviation 7.8 |
| Late Locomotor Training Program | Berg Balance Score | 6-month change from Baseline | 5.3 units on a scale | Standard Deviation 7 |
| Late Locomotor Training Program | Berg Balance Score | Baseline | 35.9 units on a scale | Standard Deviation 14.1 |
| Late Locomotor Training Program | Berg Balance Score | 12-month change from Baseline | 5.9 units on a scale | Standard Deviation 9.1 |
| Home Exercise Program | Berg Balance Score | Baseline | 36.5 units on a scale | Standard Deviation 13.6 |
| Home Exercise Program | Berg Balance Score | 12-month change from Baseline | 8.3 units on a scale | Standard Deviation 8.8 |
| Home Exercise Program | Berg Balance Score | 6-month change from Baseline | 7.9 units on a scale | Standard Deviation 8.5 |
Comparison: 12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.06ANOVA
Comparison: 6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.001ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Locomotor Training Program | Fugl-Meyer Lower Extremity Score | 6-month change from Baseline | 2.2 units on a scale | Standard Deviation 3.4 |
| Early Locomotor Training Program | Fugl-Meyer Lower Extremity Score | Baseline | 23.7 units on a scale | Standard Deviation 6.7 |
| Early Locomotor Training Program | Fugl-Meyer Lower Extremity Score | 12-month change from Baseline | 1.7 units on a scale | Standard Deviation 3.9 |
| Late Locomotor Training Program | Fugl-Meyer Lower Extremity Score | 6-month change from Baseline | 1.3 units on a scale | Standard Deviation 3.3 |
| Late Locomotor Training Program | Fugl-Meyer Lower Extremity Score | Baseline | 24.8 units on a scale | Standard Deviation 6.4 |
| Late Locomotor Training Program | Fugl-Meyer Lower Extremity Score | 12-month change from Baseline | 1.5 units on a scale | Standard Deviation 3.7 |
| Home Exercise Program | Fugl-Meyer Lower Extremity Score | Baseline | 24.7 units on a scale | Standard Deviation 6.3 |
| Home Exercise Program | Fugl-Meyer Lower Extremity Score | 12-month change from Baseline | 2.5 units on a scale | Standard Deviation 4.3 |
| Home Exercise Program | Fugl-Meyer Lower Extremity Score | 6-month change from Baseline | 2.4 units on a scale | Standard Deviation 4.1 |
Comparison: 12 month primary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.13ANOVA
Comparison: 6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.04ANOVA
Secondary
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
Population: Intention to treat analysis. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Locomotor Training Program | Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke | 50.4 percent of participants |
| Late Locomotor Training Program | Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke | 32.2 percent of participants |
| Home Exercise Program | Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke | 49.2 percent of participants |
Comparison: Logistic regression was used to compare the proportion of participants who improved functional level of walking between early-LTP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).p-value: 0.0195% CI: [1.18, 3.21]Regression, Logistic
Comparison: Logistic regression was used to compare the proportion of participants who improved functional level of walking between HEP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).p-value: 0.00795% CI: [1.22, 3.42]Regression, Logistic
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Early Locomotor Training Program | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | 6-month change from Baseline | 1017 steps |
| Early Locomotor Training Program | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | Baseline | 1468 steps |
| Early Locomotor Training Program | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | 12-month change from Baseline | 858 steps |
| Late Locomotor Training Program | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | 6-month change from Baseline | 565.5 steps |
| Late Locomotor Training Program | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | Baseline | 1664 steps |
| Late Locomotor Training Program | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | 12-month change from Baseline | 1022 steps |
| Home Exercise Program | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | Baseline | 1882.5 steps |
| Home Exercise Program | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | 12-month change from Baseline | 1471 steps |
| Home Exercise Program | Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day | 6-month change from Baseline | 1357 steps |
Comparison: 12 month primary outcome. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.p-value: 0.1Kruskal-Wallis
Comparison: 6 month secondary analysis. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.p-value: 0.04Kruskal-Wallis
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Locomotor Training Program | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | 6-month change from baseline | 9.8 units on a scale | Standard Deviation 17.2 |
| Early Locomotor Training Program | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | Baseline | 54.1 units on a scale | Standard Deviation 20.1 |
| Early Locomotor Training Program | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | 12-month change from baseline | 9.6 units on a scale | Standard Deviation 19.5 |
| Late Locomotor Training Program | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | 6-month change from baseline | 7.0 units on a scale | Standard Deviation 17.8 |
| Late Locomotor Training Program | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | Baseline | 55.7 units on a scale | Standard Deviation 20.4 |
| Late Locomotor Training Program | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | 12-month change from baseline | 9.4 units on a scale | Standard Deviation 17.2 |
| Home Exercise Program | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | Baseline | 54.4 units on a scale | Standard Deviation 20.7 |
| Home Exercise Program | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | 12-month change from baseline | 14.5 units on a scale | Standard Deviation 19 |
| Home Exercise Program | Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL) | 6-month change from baseline | 13.0 units on a scale | Standard Deviation 16.9 |
Comparison: 12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.07ANOVA
Comparison: 6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.03ANOVA
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Locomotor Training Program | Stroke Impact Scale (SIS) - Mobility | 6-month change from baseline | 15.3 units on a scale | Standard Deviation 21.4 |
| Early Locomotor Training Program | Stroke Impact Scale (SIS) - Mobility | Baseline | 57.0 units on a scale | Standard Deviation 22.1 |
| Early Locomotor Training Program | Stroke Impact Scale (SIS) - Mobility | 12-month change from baseline | 13.7 units on a scale | Standard Deviation 21.6 |
| Late Locomotor Training Program | Stroke Impact Scale (SIS) - Mobility | 6-month change from baseline | 7.0 units on a scale | Standard Deviation 15.7 |
| Late Locomotor Training Program | Stroke Impact Scale (SIS) - Mobility | Baseline | 60.5 units on a scale | Standard Deviation 20.7 |
| Late Locomotor Training Program | Stroke Impact Scale (SIS) - Mobility | 12-month change from baseline | 12.0 units on a scale | Standard Deviation 19.1 |
| Home Exercise Program | Stroke Impact Scale (SIS) - Mobility | Baseline | 59.1 units on a scale | Standard Deviation 19.5 |
| Home Exercise Program | Stroke Impact Scale (SIS) - Mobility | 12-month change from baseline | 14.2 units on a scale | Standard Deviation 20.3 |
| Home Exercise Program | Stroke Impact Scale (SIS) - Mobility | 6-month change from baseline | 14.9 units on a scale | Standard Deviation 20 |
Comparison: 12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.69ANOVA
Comparison: 6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: <0.0001ANOVA
Secondary
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.
Time frame: Baseline, 6 months and 12 months post-stroke
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early Locomotor Training Program | Stroke Impact Scale (SIS) - Participation | 6 month change from Baseline | 11.8 units on a scale | Standard Deviation 26.8 |
| Early Locomotor Training Program | Stroke Impact Scale (SIS) - Participation | Baseline | 45.0 units on a scale | Standard Deviation 23.3 |
| Early Locomotor Training Program | Stroke Impact Scale (SIS) - Participation | 12 month change from Baseline | 17.1 units on a scale | Standard Deviation 25.9 |
| Late Locomotor Training Program | Stroke Impact Scale (SIS) - Participation | 6 month change from Baseline | 7.7 units on a scale | Standard Deviation 20.5 |
| Late Locomotor Training Program | Stroke Impact Scale (SIS) - Participation | Baseline | 46.6 units on a scale | Standard Deviation 23 |
| Late Locomotor Training Program | Stroke Impact Scale (SIS) - Participation | 12 month change from Baseline | 13.1 units on a scale | Standard Deviation 22 |
| Home Exercise Program | Stroke Impact Scale (SIS) - Participation | Baseline | 44.8 units on a scale | Standard Deviation 23.5 |
| Home Exercise Program | Stroke Impact Scale (SIS) - Participation | 12 month change from Baseline | 14.4 units on a scale | Standard Deviation 20.6 |
| Home Exercise Program | Stroke Impact Scale (SIS) - Participation | 6 month change from Baseline | 14.7 units on a scale | Standard Deviation 22.9 |
Comparison: 12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.48ANOVA
Comparison: 6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.p-value: 0.06ANOVA