Katharine Scrivener, Elisha Ball, Catherine Dean, Joanne Glinsky, Louise Ada, Petra Graham, Nicholas Young, Karen Felton, Natasha A Lannin
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引用次数: 0
Abstract
Background: Maintaining mobility in the long term after stroke can be challenging. Furthermore, access to ongoing physiotherapy or exercise programs is limited. There is a need to investigate new models of service delivery to improve mobility in the longer term after stroke. A mobility booster program may be a solution, facilitating short-term access to physiotherapy on an as-needed basis. The aim of this project is to determine the feasibility of conducting a clinical trial of a short-term, high-dose mobility booster program (HiWalk) and measure clinical outcomes in order to estimate the power for a future efficacy trial.
Method: A multi-site, assessor-blinded pilot randomized trial will be undertaken to compare HiWalk in addition to usual care with usual care alone in 50 participants. Feasibility outcomes include recruitment, adherence, and safety. Clinical outcomes include walking speed, capacity and self-efficacy at 1-month and 6-months.
Discussion: A mobility booster program may be a successful way to deliver mobility training in the longer term after stroke. This pilot trial will progress the investigation of this model and assist in planning a future definitive trial. Most importantly, it will confirm the feasibility of delivering a novel high-dose, short-term booster program.
期刊介绍:
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.