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: March 5, 2013

Last verified: December 2012

History of Changes

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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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 ]

Show Outcome Measure 1

2. Primary:

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

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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 ]

Show Outcome Measure 3

4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. Secondary:

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

Show Outcome Measure 10

11. Secondary:

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

Show Outcome Measure 11

12. Secondary:

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