Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
NCT Number: NCT03792126
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Bournemouth, Dorset, BH7 7DW, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
The Royal Bournemouth Hospital
Other
A Pilot Cluster Randomised Controlled Trial, of an Implicit Learning Approach (ILA) Versus Standard Care, on Recovery of Mobility Following Stroke
Acronym: IMPS
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.
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