The purpose of this 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 at home. In addition, we want to know when is the best time to provide the training after a stroke and if the training is beneficial whether the stroke was mild, moderate, or severe.
PI: Pamela Duncan, PhD
Project Type: Clinical Trial
Funders/Sponsors: National Institute of Neurological Disorders and Stroke (NINDS)
The proposed objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to conduct a 5 year, phase-III, 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 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. Four hundred subjects will be enrolled from 5 sites.