Locomotor Experience Applied Post Stroke Trial — LEAPS  

Stroke Clinical Trial

Official title: Locomotor Experience Applied Post Stroke (LEAPS) Trial

Status Completed

Clinical Trial Summary

The purpose of this study is to compare two different treatments to improve walking after stroke (or post-stroke).

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT00243919
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 3
• Start date: April 2006
• Completion date: June 2012