Clinical trial NCT00243919: Locomotor Experience Applied Post Stroke Trial
Official title: Locomotor Experience Applied Post Stroke (LEAPS) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: stroke
locomotor
exercise
walking
training program
body weight support training
physical therapy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2005-10-25
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Percentage of Patients Who Successfully Improved Functional Level of Walking at 1 Year Post-stroke
timeFrame: 12 months post-stroke
measure: Walking Speed: Measured During a 10-meter Walk
timeFrame: Baseline and 12 months post-stroke
Secondary outcomes:
measure: Percentage of Patients Who Successfully Improved Functional Level of Walking at 6 Months Post-stroke
timeFrame: Baseline and 6 months post-stroke
measure: 6 Month Outcome: Walking Speed: Measured During a 10-meter Walk
timeFrame: Baseline and 6 months post-stroke
measure: 6 Minute Walking Distance (Meters)
timeFrame: Baseline, 6 months and 12 months post-stroke
measure: Step Activity Monitor (SAM)- Median of Average Number of Steps Per Day
timeFrame: Baseline, 6 months and 12 months post-stroke
measure: Stroke Impact Scale (SIS) - Participation
timeFrame: Baseline, 6 months and 12 months post-stroke
measure: Stroke Impact Scale (SIS) - Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
timeFrame: Baseline, 6 months and 12 months post-stroke
measure: Stroke Impact Scale (SIS) - Mobility
timeFrame: Baseline, 6 months and 12 months post-stroke
measure: Fugl-Meyer Lower Extremity Score
timeFrame: Baseline, 6 months and 12 months post-stroke
measure: Berg Balance Score
timeFrame: Baseline, 6 months and 12 months post-stroke
measure: Activities Specific Balance Confidence (ABC) Score
timeFrame: Baseline, 6 months and 12 months post-stroke
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: Centinela Freeman Memorial Hospital
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: University of Southern California - PT Associates
state: California
city: San Diego
country: United States
facility: Sharp Memorial Rehabilitation Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Brooks Rehabilitation Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Durham
country: United States
facility: Duke University (Administrative Coordinating Center)
state: North Carolina
Study officials:
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
name: Pamela W. Duncan, PhD, PT, FAPTA, FAHA
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-Principal Investigator, Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, California
name: Katherine J. Sullivan, Ph.D., PT
role: PRINCIPAL_INVESTIGATOR
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
name: Andrea L. Behrman, Ph.D., PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Director Data Management Core, Biostatistics Division, Department of Preventive Medicine, University of Southern California, Los Angeles, California
name: Stanley P. Azen, Ph.D.,
role: STUDY_DIRECTOR
affiliation: Lead Biostatistician - Investigator, Department of Epidemiology and Health Policy Research, University of Florida
name: Samuel S. Wu, Ph.D.
role: STUDY_DIRECTOR
affiliation: Investigator, Department of Neurology, University of California, Los Angeles, California
name: Bruce H. Dobkin, MD
role: STUDY_DIRECTOR
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
name: Stephen E. Nadeau, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.