一项旨在改善中风后患者户外移动能力的康复多中心随机对照试验：一项随机对照试验的研究方案。

A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: study protocol for a randomised controlled trial.

机构信息

Division of Rehabilitation and Aging, University of Nottingham, Nottingham, UK.

出版信息

Trials. 2012 Jun 21;13:86. doi: 10.1186/1745-6215-13-86.

DOI:10.1186/1745-6215-13-86

PMID:22721452

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3533758/

Abstract

BACKGROUND

Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person's quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care.

METHODS/DESIGN: This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session.Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries), satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected.The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect), age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence intervals will be presented.

DISCUSSION

This study protocol describes a pragmatic randomised controlled trial that will hopefully provide robust evidence of the benefit of outdoor mobility interventions after stroke for clinicians working in the community. The results will be available towards the end of 2012.

TRIAL REGISTRATION

ISRCTN58683841.

摘要

背景

多达 42%的中风患者无法像他们希望的那样经常出门。这会影响一个人的生活质量。本研究通过将新的户外机动性康复干预措施与常规护理进行比较，来测试其临床效果和成本效益。

方法/设计：这是一项多中心平行组个体随机对照试验。通过 15 个初级和二级保健机构招募至少 506 名参与者，如果他们年龄在 18 岁以上、曾中风且希望更频繁地出门，则有资格参加。参与者被随机分配到干预组或对照组。干预组参与者在最多四个月内接受多达 12 次康复户外机动性治疗。干预的主要组成部分是与治疗师一起反复练习户外机动性。对照组参与者接受户外机动性限制的常规干预：一次会议上提供口头建议和传单。使用邮寄问卷、旅行日历和独立评估者收集结果测量值。主要结果测量值是招募后六个月 SF36v2 生活质量评估的社会功能领域。次要结果测量值包括：功能能力、机动性、出行次数（每月旅行日记）、对户外机动性的满意度、情绪、健康相关生活质量、卫生和社会保健资源的使用、照顾者情绪信息。SF-36v2 的平均社会功能评分将在治疗组之间使用混合效应混合回归分析的多成员形式进行比较，调整中心（作为固定效应）、年龄和基线社会功能评分作为协变量以及治疗师作为多成员随机效应。将呈现回归系数和 95%置信区间。