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Locomotor Experience Applied Post Stroke Trial (LEAPS)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Early locomotor training program
Late locomotor training program
Home Exercise Program
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, locomotor, exercise, walking, training program, body weight support training, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 exclusion criteria will be determined by a chart review, depression screen and subject interview by study physician or study coordinator. After initial chart and subject interview, each subject's treating physician will be asked to review inclusion and exclusion criteria and provide a letter supporting inclusion in the study. All subjects who meet selection criteria must successfully complete an exercise tolerance test

Sites / Locations

  • Centinela Freeman Memorial Hospital
  • Long Beach Memorial Hospital
  • University of Southern California - PT Associates
  • Sharp Memorial Rehabilitation Center
  • University of Florida
  • Brooks Rehabilitation Hospital
  • Florida Hospital
  • Duke University (Administrative Coordinating Center)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Early Locomotor Training Program

Late Locomotor Training Program

Early Home Exercise Program

Arm Description

body weight supported training program with treadmill

body weight supported training program with treadmill

a non-specific low intensity exercise program

Outcomes

Primary Outcome Measures

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.
Walking Speed: Measured During a 10-meter Walk

Secondary Outcome Measures

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.
6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
6 Minute Walking Distance (Meters)
Distance walked in 6 minutes.
Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day
As measured with a step activity monitor averaged over 2 days.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 24, 2005
Last Updated
July 9, 2014
Sponsor
Duke University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00243919
Brief Title
Locomotor Experience Applied Post Stroke Trial
Acronym
LEAPS
Official Title
Locomotor Experience Applied Post Stroke (LEAPS) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, locomotor, exercise, walking, training program, body weight support training, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Locomotor Training Program
Arm Type
Active Comparator
Arm Description
body weight supported training program with treadmill
Arm Title
Late Locomotor Training Program
Arm Type
Active Comparator
Arm Description
body weight supported training program with treadmill
Arm Title
Early Home Exercise Program
Arm Type
Active Comparator
Arm Description
a non-specific low intensity exercise program
Intervention Type
Behavioral
Intervention Name(s)
Early locomotor training program
Other Intervention Name(s)
E-LTP, LTP-early
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Late locomotor training program
Other Intervention Name(s)
L-LTP, LTP-late
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home Exercise Program
Other Intervention Name(s)
HEP
Intervention Description
Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.
Primary Outcome Measure Information:
Title
Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke
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
Title
Walking Speed: Measured During a 10-meter Walk
Time Frame
Baseline and 12 months post-stroke
Secondary Outcome Measure Information:
Title
Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke
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
Title
6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
Time Frame
Baseline and 6 months post-stroke
Title
6 Minute Walking Distance (Meters)
Description
Distance walked in 6 minutes.
Time Frame
Baseline, 6 months and 12 months post-stroke
Title
Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day
Description
As measured with a step activity monitor averaged over 2 days.
Time Frame
Baseline, 6 months and 12 months post-stroke
Title
Stroke Impact Scale (SIS) - Participation
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
Title
Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
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
Title
Stroke Impact Scale (SIS) - Mobility
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
Title
Fugl-Meyer Lower Extremity Score
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
Title
Berg Balance Score
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
Title
Activities Specific Balance Confidence (ABC) Score
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 exclusion criteria will be determined by a chart review, depression screen and subject interview by study physician or study coordinator. After initial chart and subject interview, each subject's treating physician will be asked to review inclusion and exclusion criteria and provide a letter supporting inclusion in the study. All subjects who meet selection criteria must successfully complete an exercise tolerance test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela W. Duncan, PhD, PT, FAPTA, FAHA
Organizational Affiliation
Professor and Bette Busch Maniscalco, Doctor of Physical Therapy Division, Research Fellow, Department of Community and Family Medicine, Duke Center for Clinical Health Policy Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katherine J. Sullivan, Ph.D., PT
Organizational Affiliation
Co-Principal Investigator, Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea L. Behrman, Ph.D., PT
Organizational Affiliation
Co-Principal Investigator, Department of Physical Therapy, Brooks Center for Rehabilitation Studies, University of Florida, and Department of Veteran Affairs Brain Rehabilitation Research Center, Gainesville, Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stanley P. Azen, Ph.D.,
Organizational Affiliation
Director Data Management Core, Biostatistics Division, Department of Preventive Medicine, University of Southern California, Los Angeles, California
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samuel S. Wu, Ph.D.
Organizational Affiliation
Lead Biostatistician - Investigator, Department of Epidemiology and Health Policy Research, University of Florida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bruce H. Dobkin, MD
Organizational Affiliation
Investigator, Department of Neurology, University of California, Los Angeles, California
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephen E. Nadeau, MD
Organizational Affiliation
Investigator, Geriatric Research, Education and Clinical Center and the Brain Rehabilitation Research Center, Gainesville VA Medical Center, and the Department of Neurology, University of Florida College of Medicine, Gainesville, Fl
Official's Role
Study Director
Facility Information:
Facility Name
Centinela Freeman Memorial Hospital
City
Inglewood
State/Province
California
Country
United States
Facility Name
Long Beach Memorial Hospital
City
Long Beach
State/Province
California
Country
United States
Facility Name
University of Southern California - PT Associates
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Sharp Memorial Rehabilitation Center
City
San Diego
State/Province
California
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Brooks Rehabilitation Hospital
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Duke University (Administrative Coordinating Center)
City
Durham
State/Province
North Carolina
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33481989
Citation
Seamon BA, Kautz SA, Velozo CA. Measurement Precision and Efficiency of Computerized Adaptive Testing for the Activities-specific Balance Confidence Scale in People With Stroke. Phys Ther. 2021 Apr 4;101(4):pzab020. doi: 10.1093/ptj/pzab020.
Results Reference
derived
PubMed Identifier
26498434
Citation
Nadeau SE, Dobkin B, Wu SS, Pei Q, Duncan PW; LEAPS Investigative Team. The Effects of Stroke Type, Locus, and Extent on Long-Term Outcome of Gait Rehabilitation: The LEAPS Experience. Neurorehabil Neural Repair. 2016 Aug;30(7):615-25. doi: 10.1177/1545968315613851. Epub 2015 Oct 23.
Results Reference
derived
PubMed Identifier
23504552
Citation
Nadeau SE, Wu SS, Dobkin BH, Azen SP, Rose DK, Tilson JK, Cen SY, Duncan PW; LEAPS Investigative Team. Effects of task-specific and impairment-based training compared with usual care on functional walking ability after inpatient stroke rehabilitation: LEAPS Trial. Neurorehabil Neural Repair. 2013 May;27(4):370-80. doi: 10.1177/1545968313481284. Epub 2013 Mar 15.
Results Reference
derived
PubMed Identifier
22246687
Citation
Tilson JK, Wu SS, Cen SY, Feng Q, Rose DR, Behrman AL, Azen SP, Duncan PW. Characterizing and identifying risk for falls in the LEAPS study: a randomized clinical trial of interventions to improve walking poststroke. Stroke. 2012 Feb;43(2):446-52. doi: 10.1161/STROKEAHA.111.636258. Epub 2012 Jan 12.
Results Reference
derived
PubMed Identifier
21612471
Citation
Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790.
Results Reference
derived
PubMed Identifier
17996052
Citation
Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.
Results Reference
derived

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Locomotor Experience Applied Post Stroke Trial

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