Skip to main content
OpenTrials
Completed

NCT Number: NCT03792126

Implicit Learning in Stroke Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implicit Learning Approach

Other

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 - and primarily involves changing the quantity and focus of attention of instructions and feedback.

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.

Primary outcomes

  1. Change in Modified Rivermead Mobility Index Score

    Time frame: 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 outcomes

  1. Swedish Postural Adjustment in Stroke Scale (SwePASS)

    Time frame: 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.

Other outcomes

  1. Fugl Meyer - Motor Leg Sub Section

    Time frame: Week 0, week 2 and week 12

    Measure of sensori-motor function in the lower limb (impairment level)

    Range 0-28, with higher score indicating better outcome.

  2. Modified Rankin Score

    Time frame: Week 0, Week 12

    Measure of disability and dependence in people who have suffered a stroke.

    Score 0-6, with higher score indicating a worse outcome.

  3. EuroQOL 5 D Questionnaire Index Score

    Time frame: 3 months

    Standardised self-administered questionnaire to measure health related quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored based on the participant ticking the statement that best fits them. The statements range from "I have no problems..." to "I am unable to..." and are given a score 1-5 with a total score being between 5 and 25. Higher score indicates a worse outcome.

Sponsors and collaborators

Lead sponsor

The Royal Bournemouth Hospital

Other

Collaborators

  • University of Southampton

Registry information

Official study title

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

Acronym: IMPS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 3, 2019
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.