Prospective, open-label, randomised, multicentre, pilot clinical trial involving about 700 stroke survivors to (a) explore the feasibility of recruitment and likely level of support required to uptake the intervention; (b) to inform the power calculation, identify the inclusion criteria and best primary outcome measure for conducting a full-scale randomised controlled trial; and (c) to assess preliminary efficacy of a DVD-based observational learning intervention in stroke survivors for improving their functional outcomes at 3 months after randomisation.

ational Institute for Stroke & Applied Neurosciences, AUT University0 个研究点目标入组 700 人开始时间: 2012年12月12日最近更新: 2020年1月13日

研究概览

暂无简介。

•All consecutive patients with stroke admitted to participating centers will be potentially eligible for inclusion in the study if they meet all the following inclusion criteria: (1) clinically diagnosed stroke with some level of disability; (2) discharged home; and (3) availability of home DVD-player. All such patients and their informal (unpaid) caregiver (next of kin or the person providing most day-to-day support, whenever available) will be approached couple days before or after their discharge to home but no later than 9 months after the stroke onset.

•inability to communicate (including non-fluent English), history of previous disabling stroke (pre-stroke MRS 3-5), living outside the study area, admission to hospital from a residential care facility or rest home, inability to provide informed consent, participation in another clinical trial, significant cognitive impairment that would affect their understanding of the instructions and compliance with the intervention (by opinion of the treating physician or rehabilitation specialist at the time of the interview), or history of alcoholism, drug abuse, or serious mental illness (e.g. depression, psychosis, bipolar disorder).

发起方

ational Institute for Stroke & Applied Neurosciences, AUT University