Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
408 participants
INTERVENTIONAL
2006-04-30
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Understanding Different Parameters in Locomotor Training (a Type of Walking Training) for Person After a Stroke
NCT00712179
Locomotor Training (Walking Therapy) Post Stroke
NCT00715299
Retraining the Walking Pattern After Stroke
NCT03813342
Coordination of Hemiparetic Movement After Post-Stroke Rehabilitation
NCT00013481
Locomotor Recovery and Compensation Post-stroke (LRC)
NCT05081713
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early Locomotor Training Program
body weight supported training program with treadmill
Early locomotor training program
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 Program
body weight supported training program with treadmill
Late locomotor training program
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.
Early Home Exercise Program
a non-specific low intensity exercise program
Home Exercise Program
Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Early locomotor training program
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 program
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 Program
Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pamela W. Duncan, PhD, PT, FAPTA, FAHA
Role: 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
Role: PRINCIPAL_INVESTIGATOR
Co-Principal Investigator, Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California
Andrea L. Behrman, Ph.D., PT
Role: 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
Stanley P. Azen, Ph.D.,
Role: STUDY_DIRECTOR
Director Data Management Core, Biostatistics Division, Department of Preventive Medicine, University of Southern California, Los Angeles, California
Samuel S. Wu, Ph.D.
Role: STUDY_DIRECTOR
Lead Biostatistician - Investigator, Department of Epidemiology and Health Policy Research, University of Florida
Bruce H. Dobkin, MD
Role: STUDY_DIRECTOR
Investigator, Department of Neurology, University of California, Los Angeles, California
Stephen E. Nadeau, MD
Role: 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
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centinela Freeman Memorial Hospital
Inglewood, California, United States
Long Beach Memorial Hospital
Long Beach, California, United States
University of Southern California - PT Associates
Los Angeles, California, United States
Sharp Memorial Rehabilitation Center
San Diego, California, United States
University of Florida
Gainesville, Florida, United States
Brooks Rehabilitation Hospital
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Duke University (Administrative Coordinating Center)
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00006846
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.