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临床试验/NCT03792126
NCT03792126已完成不适用

A Pilot Cluster Randomised Controlled Trial, of an Implicit Learning Approach (ILA) Versus Standard Care, on Recovery of Mobility Following Stroke

The Royal Bournemouth Hospital2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
Change in Modified Rivermead Mobility Index Score

研究概览

简要总结

This trial will compare an Implicit Learning Approach (ILA) to usual care, during the rehabilitation of mobility post stroke.

It is a multicentre, assessor blind, cluster randomised controlled pilot trial, with embedded feasibility study. It also includes a nested qualitative evaluation, designed to explore the views of participants and therapists.

详细描述

Re-gaining the ability to stand, step and walk are common goals for people with stroke. During rehabilitation, therapists often tell people how to move, e.g. "straighten your knee when you're standing", or "lift your foot as you step". However, these types of specific instructions may not help people to learn new skills. Reducing the number of instructions or using simpler instructions may help people to learn in a more automatic way - e.g. through trial and error. This is called implicit learning.

There is very little evidence into implicit learning in stroke. This study will investigate whether patients recover the ability stand, step and walk following stroke better when they are given fewer and simpler instructions.

We will do this using a cluster randomised design. We will invite up to 8 stroke units to take part - half will continue to deliver usual rehabilitation, and half will adopt an Implicit Learning Approach (ILA) for the duration of the trial. Which one of the two approaches the unit delivers will be chosen at random. At the ILA sites, therapists will be trained to deliver rehabilitation using fewer and less complex instructions.

All patients at each unit will receive their rehabilitation using the allocated approach. This helps to ensure that the therapy teams manage to deliver the interventions effectively. We will ask individual patients for permission to complete additional assessments, which form part of the study. Some participants and clinicians will be interviewed at the end of the study, to find out what they thought about the intervention.

This is a pilot study, meaning that we are testing how well this works as a research method. We will not know for certain which approach is best, but it will tell us how we should design a larger trial that will give a clear answer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of stroke, presenting with hemiplegia
  • Within 14 days of stroke onset
  • Medically stable
  • Able to...
  • tolerate daily therapy for a minimum of 30 minutes per session
  • sit for more than 5 seconds without support
  • understand and follow 1 stage commands

排除标准

  • Previous stroke with residual impairments
  • Other neurological diagnosis (e.g. Parkinsons Disease, Multiple Sclerosis)
  • Clinically relevant pre-morbid disability levels

结局指标

主要结局

Change in Modified Rivermead Mobility Index Score

时间窗: 12 weeks

Measure of functional mobility in people with stroke. Ordinal scale, measured through direct observation of function. Score range from 0-40, with a higher score indicating better functional mobility status.

次要结局

  • Swedish Postural Adjustment in Stroke Scale (SwePASS)(Week 0, 2 and 12)

研究者

发起方
The Royal Bournemouth Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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