Implicit Learning in Stroke Study

Not Applicable

Completed

Conditions: Stroke

Interventions: Other: Implicit Learning Approach

Registration Number: NCT03792126

Lead Sponsor: The Royal Bournemouth Hospital

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implicit Learning Approach	Implicit Learning Approach	-

Primary Outcome Measures

Name	Time	Method
Change in Modified Rivermead Mobility Index Score	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.

Secondary Outcome Measures

Name	Time	Method
Swedish Postural Adjustment in Stroke Scale (SwePASS)	Week 0, 2 and 12	Measure of postural control in people with stroke, from lying, sitting and standing postures. Ordinal scale, measured through direct observation of function. Score range from 0-36, with a higher score indicating better postural control.