Clinical trial NCT03792126: Implicit Learning in Stroke Study
Official title: A Pilot Cluster Randomised Controlled Trial, of an Implicit Learning Approach (ILA) Versus Standard Care, on Recovery of Mobility Following Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
Collaborators: name: University of Southampton
First posted: 2019-01-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Modified Rivermead Mobility Index Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Swedish Postural Adjustment in Stroke Scale (SwePASS)
timeFrame: Week 0, 2 and 12
Other outcomes:
measure: Fugl Meyer - Motor Leg Sub Section
timeFrame: Week 0, week 2 and week 12
measure: Modified Rankin Score
timeFrame: Week 0, Week 12
measure: EuroQOL 5 D Questionnaire Index Score
timeFrame: 3 months
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: Dorset
Study officials:
affiliation: University Hospitals Dorset
name: Louise Johnson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson L, Burridge J, Ewings S, Westcott E, Gayton M, Demain S. Principles into Practice: An Observational Study of Physiotherapists use of Motor Learning Principles in Stroke Rehabilitation. Physiotherapy. 2023 Mar;118:20-30. doi: 10.1016/j.physio.2022.06.002. Epub 2022 Jun 20.
citation: Johnson L, Burridge J, Demain S, Ewings S. Comparing the Impact of an Implicit Learning Approach With Standard Care on Recovery of Mobility Following Stroke: Protocol for a Pilot Cluster Randomized Controlled Trial. JMIR Res Protoc. 2019 Nov 5;8(11):e14222. doi: 10.2196/14222.