Locomotor Experience Applied Post Stroke Trial (LEAPS)

This study has been completed.
Sponsor:
Collaborator:
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  
Number of Participants  
[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  
Modified Rankin Scale [2]
[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  
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 [3]
[units: scores on a scale]
Mean ± Standard Deviation
  26.0  ± 3.2     26.2  ± 3.7     26.0  ± 3.6     26.1  ± 3.5  
Walking Speed (m/sec) [4]
[units: participants]
       
Severe Disability (<0.4 m/sec)     75     77     66     218  
Moderate Disability (0.4 - 0.8 m/sec)     64     66     60     190  
Comfortable walking speed (m/sec) [5]
[units: m/sec]
Mean ± Standard Deviation
  0.36  ± 0.22     0.38  ± 0.23     0.39  ± 0.22     0.38  ± 0.22  
[1] Based on CT/MRI overread by study neurologists.
[2] Global measure of stroke disability
[3] Higher Score is Better;Range = 0-30
[4] Comfortable walking speed assessed by 10 meter walk.
[5] Assessed with 10 meter walk test.



  Outcome Measures
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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


No publications provided by Duke University

Publications automatically indexed to this study:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00243919     History of Changes
Other Study ID Numbers: Pro00006846, R01NS050506
Study First Received: October 24, 2005
Results First Received: March 29, 2011
Last Updated: July 9, 2014
Health Authority: United States: Federal Government