StrokePhase 3LEAPSNCT00243919
Locomotor Experience Applied Post Stroke Trial
A Phase 3 study testing Early locomotor training program, Late locomotor training program and Home Exercise Program in people with Stroke, run by Duke University at 8 sites in United States.
Trial summary
The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Early locomotor training program, Late locomotor training program and Home Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2006to Jun 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Duke University (Administrative Coordinating Center)
Durham, North Carolina
University of Florida
Gainesville, Florida
Centinela Freeman Memorial Hospital
Inglewood, California
Brooks Rehabilitation Hospital
Jacksonville, Florida
Long Beach Memorial Hospital
Long Beach, California
University of Southern California - PT Associates
Los Angeles, California
Florida Hospital
Orlando, Florida
Sharp Memorial Rehabilitation Center
San Diego, California
About this study
Official title: Locomotor Experience Applied Post Stroke (LEAPS) Trial
The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).
Read the 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).
- Conditions
- Stroke
- Being tested
- Early locomotor training program, Late locomotor training program, Home Exercise Program
- Keywords
- stroke, locomotor, exercise, walking, training program, body weight support training, physical therapy
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early locomotor training programBehavioural
Also called E-LTP, LTP-early
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.
Late locomotor training programBehavioural
Also called L-LTP, LTP-late
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.
Home Exercise ProgramBehavioural
Also called HEP
Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.
| Study group | Role | What they receive |
|---|---|---|
| Early Locomotor Training Program | Active comparator | body weight supported training program with treadmill Receives: Behavioral: Early locomotor training program |
| Late Locomotor Training Program | Active comparator | body weight supported training program with treadmill Receives: Behavioral: Late locomotor training program |
| Early Home Exercise Program | Active comparator | a non-specific low intensity exercise program Receives: Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-stroke
Walking Speed: Measured During a 10-meter Walk
Measured: Baseline and 12 months post-stroke
Secondary outcomes (10)
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.
Measured: Baseline and 6 months post-stroke
6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
Measured: Baseline and 6 months post-stroke
6 Minute Walking Distance (Meters)
Distance walked in 6 minutes.
Measured: Baseline, 6 months and 12 months post-stroke
Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day
As measured with a step activity monitor averaged over 2 days.
Measured: Baseline, 6 months and 12 months post-stroke
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.
Measured: Baseline, 6 months and 12 months post-stroke
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.
Measured: Baseline, 6 months and 12 months post-stroke
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.
Measured: Baseline, 6 months and 12 months post-stroke
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.
Measured: Baseline, 6 months and 12 months post-stroke
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.
Measured: Baseline, 6 months and 12 months post-stroke
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.
Measured: Baseline, 6 months and 12 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startApr 2006
- Primary completionApr 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Pamela W. Duncan, PhD, PT, FAPTA, FAHA, Principal investigator, Professor and Bette Busch Maniscalco, Doctor of Physical Therapy Division, Research Fellow, Department of Community and Family Medicine, Duke Center for Clinical Health Policy ResearchKatherine J. Sullivan, Ph.D., PT, Principal investigator, Co-Principal Investigator, Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CaliforniaAndrea L. Behrman, Ph.D., PT, Principal investigator, 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, FloridaStanley P. Azen, Ph.D.,, Study director, Director Data Management Core, Biostatistics Division, Department of Preventive Medicine, University of Southern California, Los Angeles, CaliforniaSamuel S. Wu, Ph.D., Study director, Lead Biostatistician - Investigator, Department of Epidemiology and Health Policy Research, University of FloridaBruce H. Dobkin, MD, Study director, Investigator, Department of Neurology, University of California, Los Angeles, CaliforniaStephen E. Nadeau, MD, Study director, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243919
- Sponsor's protocol ID
- Pro00006846
- Other IDs
- R01NS050506
- Acronym
- LEAPS
- Status last verified
- Dec 2012
- First submitted
- 24 Oct 2005
- Last updated
- 16 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Seamon BA, Kautz SA, Velozo CA. Computerized Adaptive Testing for the Berg Balance Scale Improves Measurement Efficiency Without Compromising Precision in People With Stroke. Phys Ther. 2024 Nov 1;104(11):pzae112. doi: 10.1093/ptj/pzae112.
PubMed 39113593Seamon 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.
PubMed 33481989Nadeau 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.
PubMed 26498434Nadeau 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.
PubMed 23504552Tilson 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.
PubMed 22246687Duncan 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.
PubMed 21612471Duncan 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.
PubMed 17996052
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotor Experience Applied Post Stroke (LEAPS) Trial
- ClinicalTrials.gov ID
- NCT00243919
- Acronym / sponsor ID
- LEAPS / Pro00006846
- Conditions
- Stroke
- Keywords
- stroke, locomotor, exercise, walking, training program, body weight support training, physical therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Apr 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Oct 2005 (estimated)
- Results
- Posted 22 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Locomotor Training Program | Active comparator | Behavioral: Early locomotor training programbody weight supported training program with treadmill |
| Late Locomotor Training Program | Active comparator | Behavioral: Late locomotor training programbody weight supported training program with treadmill |
| Early Home Exercise Program | Active comparator | Behavioral: Home Exercise Programa non-specific low intensity exercise program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early locomotor training programAlso: E-LTP, LTP-earlyThe 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. | Behavioural | Early Locomotor Training Program |
| Late locomotor training programAlso: L-LTP, LTP-lateThe 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. | Behavioural | Late Locomotor Training Program |
| Home Exercise ProgramAlso: HEPParticipants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke. | Behavioural | Early Home Exercise Program |
Primary outcome
Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke
Time frame: 12 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.
Walking Speed: Measured During a 10-meter Walk
Time frame: Baseline and 12 months post-stroke
10 secondary outcomes
Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke
Time frame: Baseline and 6 months post-stroke
6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
Time frame: Baseline and 6 months post-stroke
6 Minute Walking Distance (Meters)
Time frame: Baseline, 6 months and 12 months post-stroke
Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day
Time frame: Baseline, 6 months and 12 months post-stroke
Stroke Impact Scale (SIS) - Participation
Time frame: Baseline, 6 months and 12 months post-stroke
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
Stroke Impact Scale (SIS) - Mobility
Time frame: Baseline, 6 months and 12 months post-stroke
Fugl-Meyer Lower Extremity Score
Time frame: Baseline, 6 months and 12 months post-stroke
Berg Balance Score
Time frame: Baseline, 6 months and 12 months post-stroke
Activities Specific Balance Confidence (ABC) Score
Time frame: Baseline, 6 months and 12 months post-stroke
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39113593Seamon BA, Kautz SA, Velozo CA. Computerized Adaptive Testing for the Berg Balance Scale Improves Measurement Efficiency Without Compromising Precision in People With Stroke. Phys Ther. 2024 Nov 1;104(11):pzae112. doi: 10.1093/ptj/pzae112.
- Derived from this study: PubMed 33481989Seamon 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.
- Derived from this study: PubMed 26498434Nadeau 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.
- Derived from this study: PubMed 23504552Nadeau 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.
- Derived from this study: PubMed 22246687Tilson 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.
- Derived from this study: PubMed 21612471Duncan 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.
- Derived from this study: PubMed 17996052Duncan 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.
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela W. Duncan, PhD, PT, FAPTA, FAHA principal investigator
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
Katherine J. Sullivan, Ph.D., PT principal investigator
Co-Principal Investigator, Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California
Andrea L. Behrman, Ph.D., PT principal investigator
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Early locomotor training program, Late locomotor training program and Home Exercise Program in people with Stroke, run by Duke University at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke (time frame: 12 months post-stroke). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00243919, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.