At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Stroke within 45 days of enrollment
- ✓Residual lower extremity paresis (Fugl-Meyer LE score <34)
- ✓Able to sit unsupported for 30 seconds
- ✕Pre-stroke residence in nursing home
- ✕Unable to ambulate ≥150 feet before stroke or intermittent claudication at <200 meters
- ✕Serious cardiac conditions: CHF, unstable arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL; NYHA Class 3–4
- ✕Serious COPD or oxygen dependence
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Locomotor Experience Applied Post Stroke (LEAPS) Trial
In Brief
A Phase 3 clinical trial evaluating Early locomotor training program, Late locomotor training program, and 1 other intervention for Stroke. Completed, enrolled 408 participants across 8 sites.
Detailed Summary
The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).
Study Details
Timeline
Interventions
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.
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.
Participants in the early home exercise group will receive a non-specific low intensity exercise program beginning at 2 months post stroke.