Locomotor training using body weight support and a treadmill as a therapeutic modality for the rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. A recent Cohrane review highlighted the urgent need for a well-designed trial to determine the effectiveness of this intervention. The proposed objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to conduct a 5 year, phase-Ill, single-blind, multi-site (5 clinical sites) randomized clinical trial (RCT) to assess if there is a difference in the proportion of subjects who successfully recover walking ability between a specialized locomotor training program (LTP) that includes use of body weight support and a treadmill as a rehabilitation modality provided 2 months post-stroke (LTP-early) or 6 months post-stroke (LTP-late) and a non-specific, low intensity exercise (control) intervention. The study is designed to be a definitive RCT with the primary outcome being successful recovery of walking (achieving a 0.4 m/s gait speed or greater for persons with initial severe gait impairment (< 0.4 m/s) or as having achieved a 0.8 m/s gait speed or greater for persons with initial moderate gait impairment (> 0.4 m/s - < 0.8 m/s) at 1 year post-stroke. We will also determine if the timing of LTP delivery (early vs. late) affects the improvement in gait speed at 1 year and whether initial locomotor impairment severity interacts with the timing of LTP delivery. The LTP and control interventions will be delivered for 36 sessions over 12 weeks. We will recruit 400 adults, age 18 or older, within 30 days poststroke onset with moderate to severe walking ability. After screening and baseline assessment, subjects will be stratified by baseline locomotor impairment severity as determined by overground walking speed and randomly assigned to 1 of 3 groups: (a) LTP-Early; (b) LTP-Late or (c) Control. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment, post-12, post-24, and post-36 sessions. Our ultimate goal is to provide evidence to guide post-stroke rehabilitation practice and reduce disability in persons post-stroke.

National Institute of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Research Project (R01)
Project #
Application #
Study Section
Special Emphasis Panel (ZNS1-SRB-R (10))
Program Officer
Janis, Scott
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Florida
Other Health Professions
Schools of Medicine
United States
Zip Code
Hershberg, Julie A; Rose, Dorian K; Tilson, Julie K et al. (2017) The Interface of Clinical Decision-Making With Study Protocols for Knowledge Translation From a Walking Recovery Trial. J Neurol Phys Ther 41:59-67
Balasubramanian, Chitralakshmi K; Li, Chih-Ying; Bowden, Mark G et al. (2016) Dimensionality and Item-Difficulty Hierarchy of the Lower Extremity Fugl-Meyer Assessment in Individuals With Subacute and Chronic Stroke. Arch Phys Med Rehabil 97:582-589.e2
Nadeau, Stephen E; Dobkin, Bruce; Wu, Samuel S et al. (2016) The Effects of Stroke Type, Locus, and Extent on Long-Term Outcome of Gait Rehabilitation: The LEAPS Experience. Neurorehabil Neural Repair 30:615-25
Liphart, Jodi; Gallichio, Joann; Tilson, Julie K et al. (2016) Concordance and discordance between measured and perceived balance and the effect on gait speed and falls following stroke. Clin Rehabil 30:294-302
Dobkin, Bruce H K; Nadeau, Stephen E; Behrman, Andrea L et al. (2014) Prediction of responders for outcome measures of locomotor Experience Applied Post Stroke trial. J Rehabil Res Dev 51:39-50
Barak, Sharon; Wu, Samuel S; Dai, Yunfeng et al. (2014) Adherence to accelerometry measurement of community ambulation poststroke. Phys Ther 94:101-10
Nadeau, Stephen E; Lu, Xiaomin; Dobkin, Bruce et al. (2014) A prospective test of the late effects of potentially antineuroplastic drugs in a stroke rehabilitation study. Int J Stroke 9:449-56
Nadeau, Stephen E; Rose, Dorian Kay; Dobkin, Bruce et al. (2014) Likelihood of myocardial infarction during stroke rehabilitation preceded by cardiovascular screening and an exercise tolerance test: the Locomotor Experience Applied Post-Stroke (LEAPS) trial. Int J Stroke 9:1097-104
Nadeau, Stephen E; Wu, Samuel S; Dobkin, Bruce H et al. (2013) 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 27:370-80
Rose, Dorian K; Behrman, Andrea L; Nadeau, Stephen E et al. (2013) Does exercise tolerance testing at 60 days poststroke predict rehabilitation performance? Arch Phys Med Rehabil 94:1223-9

Showing the most recent 10 out of 19 publications