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Open Access Study protocol

Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol

Vincent G DePaul15*, Laurie R Wishart1, Julie Richardson1, Timothy D Lee2 and Lehana Thabane34

Author Affiliations

1 School of Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada

2 Department of Kinesiology, McMaster University, Hamilton, Ontario, Canada

3 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

4 Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare - Hamilton, Hamilton Ontario, Canada

5 Physiotherapy Department, St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

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BMC Neurology 2011, 11:129  doi:10.1186/1471-2377-11-129

Published: 21 October 2011

Abstract

Background

Although task-oriented training has been shown to improve walking outcomes after stroke, it is not yet clear whether one task-oriented approach is superior to another. The purpose of this study is to compare the effectiveness of the Motor Learning Walking Program (MLWP), a varied overground walking task program consistent with key motor learning principles, to body-weight-supported treadmill training (BWSTT) in community-dwelling, ambulatory, adults within 1 year of stroke.

Methods/Design

A parallel, randomized controlled trial with stratification by baseline gait speed will be conducted. Allocation will be controlled by a central randomization service and participants will be allocated to the two active intervention groups (1:1) using a permuted block randomization process. Seventy participants will be assigned to one of two 15-session training programs. In MLWP, one physiotherapist will supervise practice of various overground walking tasks. Instructions, feedback, and guidance will be provided in a manner that facilitates self-evaluation and problem solving. In BWSTT, training will emphasize repetition of the normal gait cycle while supported over a treadmill, assisted by up to three physiotherapists. Outcomes will be assessed by a blinded assessor at baseline, post-intervention and at 2-month follow-up. The primary outcome will be post-intervention comfortable gait speed. Secondary outcomes include fast gait speed, walking endurance, balance self-efficacy, participation in community mobility, health-related quality of life, and goal attainment. Groups will be compared using analysis of covariance with baseline gait speed strata as the single covariate. Intention-to-treat analysis will be used.

Discussion

In order to direct clinicians, patients, and other health decision-makers, there is a need for a head-to-head comparison of different approaches to active, task-related walking training after stroke. We hypothesize that outcomes will be optimized through the application of a task-related training program that is consistent with key motor learning principles related to practice, guidance and feedback.

Trial Registration

ClinicalTrials.gov # NCT00561405