Implicit Learning in Stroke Study (IMPS)

The Royal Bournemouth Hospital

Status: Completed

Conditions: Stroke

Treatments: Other: Implicit Learning Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03792126

ICA-CL-2017-03-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Standard care, as per usual working practice for the stroke unit. Control stroke units will have minimal contact with the research team, other than for data collection. They will be aware of the broad aims of the study, but not the specific detail of the intervention.

Implicit Learning Approach

Experimental group

Description:

All mobility focussed rehabilitation sessions will utilise the Implicit Learning approach (ILA), as usual care. This includes rehabilitation (delivered by a physiotherapist, occupational therapist or therapy assistant) that focusses on sitting, sit to stand, standing, stepping, transfers and walking. The content of therapy will be based on the treatment guidelines and intervention manual, which have been developed by an international expert group (using Delhi methodology). As this is a clinically grounded, pragmatic trial, therapists will have freedom to tailor the specific content of each treatment session to patient need, whilst remaining true to the ILA. Other therapy interventions, such as upper limb rehabilitation, will be provided as usual.

Treatment:

Other: Implicit Learning Approach