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Locomotor Experience Applied Post Stroke Trial (LEAPS)

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ClinicalTrials.gov Identifier: NCT00243919
Recruitment Status : Completed
First Posted : October 25, 2005
Results First Posted : September 22, 2011
Last Update Posted : July 16, 2014
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Interventions Behavioral: Early locomotor training program
Behavioral: Late locomotor training program
Behavioral: Home Exercise Program
Enrollment 408
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.
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 139 143 126
Completed 122 125 115
Not Completed 17 18 11
Reason Not Completed
Death             3             4             6
Withdrawal by Subject             6             6             2
Lost to Follow-up             6             7             3
Administrative Error             1             0             0
Physician Decision             1             1             0
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program Total
Hide Arm/Group Description 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 139 143 126 408
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 139 participants 143 participants 126 participants 408 participants
60.1  (12.3) 63.3  (12.5) 62.6  (13.3) 62.0  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 143 participants 126 participants 408 participants
Female
54
  38.8%
69
  48.3%
61
  48.4%
184
  45.1%
Male
85
  61.2%
74
  51.7%
65
  51.6%
224
  54.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 143 participants 126 participants 408 participants
Hispanic or Latino
26
  18.7%
15
  10.5%
22
  17.5%
63
  15.4%
Not Hispanic or Latino
113
  81.3%
128
  89.5%
104
  82.5%
345
  84.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 143 participants 126 participants 408 participants
American Indian or Alaska Native
2
   1.4%
2
   1.4%
1
   0.8%
5
   1.2%
Asian
19
  13.7%
20
  14.0%
15
  11.9%
54
  13.2%
Native Hawaiian or Other Pacific Islander
4
   2.9%
9
   6.3%
6
   4.8%
19
   4.7%
Black or African American
32
  23.0%
34
  23.8%
24
  19.0%
90
  22.1%
White
81
  58.3%
77
  53.8%
78
  61.9%
236
  57.8%
More than one race
0
   0.0%
1
   0.7%
2
   1.6%
3
   0.7%
Unknown or Not Reported
1
   0.7%
0
   0.0%
0
   0.0%
1
   0.2%
Time since stroke to randomization - days  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 139 participants 143 participants 126 participants 408 participants
64.1  (8.3) 64.18  (9.0) 62.9  (8.0) 63.8  (8.5)
Side of involvement  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 139 participants 143 participants 126 participants 408 participants
Left Hemiparesis 63 58 61 182
Right Hemiparesis 76 85 65 226
Stroke Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 139 participants 143 participants 126 participants 408 participants
Large Vessel 55 60 47 162
Lacune 40 45 43 128
Hemorrhage 27 22 21 70
Undefined 17 16 15 48
[1]
Measure Description: Based on CT/MRI overread by study neurologists.
Modified Rankin Scale   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 139 participants 143 participants 126 participants 408 participants
Rankin 0 - 1 (no significant disability) 0 2 0 2
Rankin 2 (slight disability) 12 21 21 54
Rankin 3 (moderate disability) 66 57 49 172
Rankin 4 (moderately severe disability) 61 63 56 180
[1]
Measure Description: Global measure of stroke disability
Comorbidities  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 139 participants 143 participants 126 participants 408 participants
Cardiovascular 36 36 37 109
Hypertension 116 111 104 331
Peripheral vascular disease 12 12 13 37
Chronic Obstructive Pulmonary Disease (COPD) 5 14 7 26
Arthritis/other musculoskeletal 47 52 47 146
Diabetes 47 51 43 141
Depression (Personal Health Questionnaire-9 >= 10) 20 28 19 67
Mini Mental Status Exam   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 139 participants 143 participants 126 participants 408 participants
26.0  (3.2) 26.2  (3.7) 26.0  (3.6) 26.1  (3.5)
[1]
Measure Description: Higher Score is Better;Range = 0-30
Walking Speed (m/sec)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 139 participants 143 participants 126 participants 408 participants
Severe Disability (<0.4 m/sec) 75 77 66 218
Moderate Disability (0.4 - 0.8 m/sec) 64 66 60 190
[1]
Measure Description: Comfortable walking speed assessed by 10 meter walk.
Comfortable walking speed (m/sec)   [1] 
Mean (Standard Deviation)
Unit of measure:  M/sec
Number Analyzed 139 participants 143 participants 126 participants 408 participants
0.36  (0.22) 0.38  (0.23) 0.39  (0.22) 0.38  (0.22)
[1]
Measure Description: Assessed with 10 meter walk test.
1.Primary Outcome
Title Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis. Missing data were imputed using the LOCF method.
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Measure Type: Number
Unit of Measure: percent of participants
50.4 53.8 51.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Home Exercise Program
Comments 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%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.481
Comments The trial tested the superiority of LTP delivered early or late, compared to HEP, using a two-sided significance level of 0.05. The study-wide error rate was controlled by applying the Hochberg step-up procedure to the two primary comparisons.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.831
Confidence Interval (2-Sided) 95%
0.497 to 1.391
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Late Locomotor Training Program, Home Exercise Program
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.501
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.192
Confidence Interval (2-Sided) 95%
0.715 to 1.985
Estimation Comments [Not Specified]
2.Primary Outcome
Title Walking Speed: Measured During a 10-meter Walk
Hide Description [Not Specified]
Time Frame Baseline and 12 months post-stroke
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Mean (Standard Deviation)
Unit of Measure: m/sec
Baseline 0.37  (0.22) 0.38  (0.23) 0.39  (0.22)
12-month change from Baseline 0.23  (0.20) 0.24  (0.23) 0.25  (0.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.242
Comments We did not formally conduct statistical inference on the timing effect because the first primary null hypotheses is accepted. The p-value provided is the smallest alpha level that one would claim significant difference between early- and late-LTP.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Estimation Comments Even though there was no formal inference of timing effect, we still provided descriptive statistics for the 6-month and 12-month changes. In addition, paired t-tests were used to compare within-group improvements.
3.Secondary Outcome
Title Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Measure Type: Number
Unit of Measure: percent of participants
50.4 32.2 49.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Regression, Logistic
Comments Pairwise comparisons were conducted: Early-LTP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.94
Confidence Interval (2-Sided) 95%
1.18 to 3.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Late Locomotor Training Program, Home Exercise Program
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Regression, Logistic
Comments Pairwise comparisons were conducted: HEP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.04
Confidence Interval (2-Sided) 95%
1.22 to 3.42
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
Hide Description [Not Specified]
Time Frame Baseline and 6 months post-stroke
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Mean (Standard Deviation)
Unit of Measure: m/sec
Baseline 0.37  (0.22) 0.38  (0.23) 0.39  (0.22)
6 month change from Baseline 0.25  (0.21) 0.13  (0.14) 0.23  (0.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p<0.0014.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.08 to 0.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p<0.0014.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.05 to 0.14
Estimation Comments [Not Specified]
5.Secondary Outcome
Title 6 Minute Walking Distance (Meters)
Hide Description Distance walked in 6 minutes.
Time Frame Baseline, 6 months and 12 months post-stroke
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Mean (Standard Deviation)
Unit of Measure: meters
Baseline 124.1  (77.5) 125.7  (81.8) 126.3  (75.0)
6-month change from baseline 81.8  (62.8) 41.0  (47.4) 75.9  (69.3)
12-month change from baseline 73.2  (69.4) 79.0  (75.1) 85.2  (72.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments Test differences across the three groups in change of 6 minute walking distance from baseline to 12-month post stroke.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of 6 minute walking distance from baseline to 6-month post stroke.
6.Secondary Outcome
Title Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day
Hide Description As measured with a step activity monitor averaged over 2 days.
Time Frame Baseline, 6 months and 12 months post-stroke
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Median (Inter-Quartile Range)
Unit of Measure: steps
Baseline
1468
(601 to 3889)
1664
(647 to 3354)
1882.5
(905 to 3384)
6-month change from Baseline
1017
(-102 to 2209)
565.5
(-362 to 2043)
1357
(84 to 3382)
12-month change from Baseline
858
(-253 to 2422)
1022
(-111 to 3009)
1471
(435 to 3481)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Kruskal-Wallis
Comments Test differences across the three groups in change of number of steps from baseline to 12-month post stroke.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Kruskal-Wallis
Comments Test differences across the three groups in change of number of steps from baseline to 6-month post stroke.
7.Secondary Outcome
Title Stroke Impact Scale (SIS) - Participation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 45.0  (23.3) 46.6  (23.0) 44.8  (23.5)
6 month change from Baseline 11.8  (26.8) 7.7  (20.5) 14.7  (22.9)
12 month change from Baseline 17.1  (25.9) 13.1  (22.0) 14.4  (20.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of SIS Participation from baseline to 12-month post stroke.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of SIS Participation from baseline to 6-month post stroke.
8.Secondary Outcome
Title Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 54.1  (20.1) 55.7  (20.4) 54.4  (20.7)
6-month change from baseline 9.8  (17.2) 7.0  (17.8) 13.0  (16.9)
12-month change from baseline 9.6  (19.5) 9.4  (17.2) 14.5  (19.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of SIS ADL/iADL from baseline to 12-month post stroke.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of SIS ADL/iADL from baseline to 6-month post stroke.
9.Secondary Outcome
Title Stroke Impact Scale (SIS) - Mobility
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 57.0  (22.1) 60.5  (20.7) 59.1  (19.5)
6-month change from baseline 15.3  (21.4) 7.0  (15.7) 14.9  (20.0)
12-month change from baseline 13.7  (21.6) 12.0  (19.1) 14.2  (20.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of SIS Mobility from baseline to 12-month post stroke.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of SIS Mobility from baseline to 6-month post stroke.
10.Secondary Outcome
Title Fugl-Meyer Lower Extremity Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 23.7  (6.7) 24.8  (6.4) 24.7  (6.3)
6-month change from Baseline 2.2  (3.4) 1.3  (3.3) 2.4  (4.1)
12-month change from Baseline 1.7  (3.9) 1.5  (3.7) 2.5  (4.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of FM-LE from baseline to 12-month post stroke.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of FM-LE from baseline to 6-month post stroke.
11.Secondary Outcome
Title Berg Balance Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 35.0  (14.4) 35.9  (14.1) 36.5  (13.6)
6-month change from Baseline 8.8  (8.1) 5.3  (7.0) 7.9  (8.5)
12-month change from Baseline 8.0  (7.8) 5.9  (9.1) 8.3  (8.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of Berg Balance Score from baseline to 12-month post stroke.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of Berg Balance Score from baseline to 6-month post stroke.
12.Secondary Outcome
Title Activities Specific Balance Confidence (ABC) Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 139 143 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 43.6  (23.5) 47.0  (25.4) 44.5  (22.6)
6-month change from Baseline 13.8  (20.8) 6.2  (20.2) 15.6  (19.4)
12-month change from Baseline 11.2  (22.3) 11.7  (22.1) 13.9  (21.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of ABC score from baseline to 12-month post stroke.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Early Locomotor Training Program, Late Locomotor Training Program, Home Exercise Program
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments Test differences across the three groups in change of ABC score from baseline to 6-month post stroke.
Time Frame Total of 10 months from point of randomization at 2 months to the 12 month final assessment.
Adverse Event Reporting Description Vital signs including heart rate, blood pressure and oxygen saturation were monitored every 5 minutes during exercise interventions. In addition monthly phone calls were used to capture rehospitalizations, recurrent stroke, MI, etc.
 
Arm/Group Title Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/139 (36.69%)      59/143 (41.26%)      39/126 (30.95%)    
Cardiac disorders       
Myocardial Infarction (MI)   0/139 (0.00%)  0 1/143 (0.70%)  1 1/126 (0.79%)  1
General disorders       
Hospitalization   45/139 (32.37%)  64 53/143 (37.06%)  83 31/126 (24.60%)  48
Limitation in activities of daily living (ADL)>48hrs   1/139 (0.72%)  1 2/143 (1.40%)  2 4/126 (3.17%)  4
Other   1/139 (0.72%)  1 1/143 (0.70%)  1 4/126 (3.17%)  4
Death   3/139 (2.16%)  3 4/143 (2.80%)  4 6/126 (4.76%)  6
Musculoskeletal and connective tissue disorders       
Fracture   8/139 (5.76%)  9 8/143 (5.59%)  8 5/126 (3.97%)  7
Vascular disorders       
Recurrent Stroke   6/139 (4.32%)  6 3/143 (2.10%)  3 1/126 (0.79%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Early Locomotor Training Program Late Locomotor Training Program Home Exercise Program
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   100/139 (71.94%)      101/143 (70.63%)      88/126 (69.84%)    
Cardiac disorders       
Excessive hypertension during exercise that requires the intervention to be stopped for the day   5/139 (3.60%)  6 8/143 (5.59%)  8 10/126 (7.94%)  11
Low blood pressure during exercise that requires intervention to be stopped for the day   8/139 (5.76%)  11 7/143 (4.90%)  7 2/126 (1.59%)  3
General disorders       
Minor fall, no or minimal injury   76/139 (54.68%)  181 77/143 (53.85%)  160 75/126 (59.52%)  150
Dizziness/Fainting   11/139 (7.91%)  11 8/143 (5.59%)  9 0/126 (0.00%)  0
Other   42/139 (30.22%)  59 47/143 (32.87%)  89 28/126 (22.22%)  48
Musculoskeletal and connective tissue disorders       
Muscle soreness or pain that persists for more than 48 hours   7/139 (5.04%)  7 12/143 (8.39%)  12 10/126 (7.94%)  10
Respiratory, thoracic and mediastinal disorders       
Dyspnea   1/139 (0.72%)  1 1/143 (0.70%)  1 0/126 (0.00%)  0
Diaphoretic   1/139 (0.72%)  1 2/143 (1.40%)  3 0/126 (0.00%)  0
Skin and subcutaneous tissue disorders       
Open sore or blister, cuts   8/139 (5.76%)  9 9/143 (6.29%)  10 11/126 (8.73%)  12
Vascular disorders       
DVT   0/139 (0.00%)  0 0/143 (0.00%)  0 1/126 (0.79%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pamela W. Duncan, PT, PhD, FAHA, FAPTA
Organization: Duke University
Phone: 919-681-2060
EMail: pamela.duncan@duke.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00243919    
Other Study ID Numbers: Pro00006846
R01NS050506 ( U.S. NIH Grant/Contract )
First Submitted: October 24, 2005
First Posted: October 25, 2005
Results First Submitted: March 29, 2011
Results First Posted: September 22, 2011
Last Update Posted: July 16, 2014