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Locomotor Experience Applied Post Stroke Trial (LEAPS)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00243919
First received: October 24, 2005
Last updated: July 9, 2014
Last verified: December 2012
Results First Received: March 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stroke
Interventions: Behavioral: Early locomotor training program
Behavioral: Late locomotor training program
Behavioral: Home Exercise Program

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 6 inpatient rehabilitation centers in California and Florida from April 2006 through June 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.
Home Exercise Program 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.

Participant Flow:   Overall Study
    Early Locomotor Training Program   Late Locomotor Training Program   Home Exercise Program
STARTED   139   143   126 
COMPLETED   122   125   115 
NOT COMPLETED   17   18   11 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
   Early Locomotor Training Program   Late Locomotor Training Program   Home Exercise Program   Total 
Overall Participants Analyzed 
[Units: Participants]
 139   143   126   408 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.1  (12.3)   63.3  (12.5)   62.6  (13.3)   62.0  (12.7) 
Gender 
[Units: Participants]
       
Female   54   69   61   184 
Male   85   74   65   224 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   26   15   22   63 
Not Hispanic or Latino   113   128   104   345 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   2   2   1   5 
Asian   19   20   15   54 
Native Hawaiian or Other Pacific Islander   4   9   6   19 
Black or African American   32   34   24   90 
White   81   77   78   236 
More than one race   0   1   2   3 
Unknown or Not Reported   1   0   0   1 
Time since stroke to randomization - days 
[Units: Days]
Mean (Standard Deviation)
 64.1  (8.3)   64.18  (9.0)   62.9  (8.0)   63.8  (8.5) 
Side of involvement 
[Units: Participants]
       
Left Hemiparesis   63   58   61   182 
Right Hemiparesis   76   85   65   226 
Stroke Type [1] 
[Units: Participants]
       
Large Vessel   55   60   47   162 
Lacune   40   45   43   128 
Hemorrhage   27   22   21   70 
Undefined   17   16   15   48 
[1] Based on CT/MRI overread by study neurologists.
Modified Rankin Scale [1] 
[Units: 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] Global measure of stroke disability
Comorbidities 
[Units: 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] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 26.0  (3.2)   26.2  (3.7)   26.0  (3.6)   26.1  (3.5) 
[1] Higher Score is Better;Range = 0-30
Walking Speed (m/sec) [1] 
[Units: Participants]
       
Severe Disability (<0.4 m/sec)   75   77   66   218 
Moderate Disability (0.4 - 0.8 m/sec)   64   66   60   190 
[1] Comfortable walking speed assessed by 10 meter walk.
Comfortable walking speed (m/sec) [1] 
[Units: M/sec]
Mean (Standard Deviation)
 0.36  (0.22)   0.38  (0.23)   0.39  (0.22)   0.38  (0.22) 
[1] Assessed with 10 meter walk test.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke   [ Time Frame: 12 months post-stroke ]

2.  Primary:   Walking Speed: Measured During a 10-meter Walk   [ Time Frame: Baseline and 12 months post-stroke ]

3.  Secondary:   Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke   [ Time Frame: Baseline and 6 months post-stroke ]

4.  Secondary:   6 Month Outcome: Walking Speed: Measured During a 10-meter Walk   [ Time Frame: Baseline and 6 months post-stroke ]

5.  Secondary:   6 Minute Walking Distance (Meters)   [ Time Frame: Baseline, 6 months and 12 months post-stroke ]

6.  Secondary:   Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day   [ Time Frame: Baseline, 6 months and 12 months post-stroke ]

7.  Secondary:   Stroke Impact Scale (SIS) - Participation   [ Time Frame: Baseline, 6 months and 12 months post-stroke ]

8.  Secondary:   Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)   [ Time Frame: Baseline, 6 months and 12 months post-stroke ]

9.  Secondary:   Stroke Impact Scale (SIS) - Mobility   [ Time Frame: Baseline, 6 months and 12 months post-stroke ]

10.  Secondary:   Fugl-Meyer Lower Extremity Score   [ Time Frame: Baseline, 6 months and 12 months post-stroke ]

11.  Secondary:   Berg Balance Score   [ Time Frame: Baseline, 6 months and 12 months post-stroke ]

12.  Secondary:   Activities Specific Balance Confidence (ABC) Score   [ Time Frame: Baseline, 6 months and 12 months post-stroke ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Pamela W. Duncan, PT, PhD, FAHA, FAPTA
Organization: Duke University
phone: 919-681-2060
e-mail: pamela.duncan@duke.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00243919     History of Changes
Other Study ID Numbers: Pro00006846
R01NS050506 ( US NIH Grant/Contract Award Number )
Study First Received: October 24, 2005
Results First Received: March 29, 2011
Last Updated: July 9, 2014