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| Name | Class |
|---|---|
| University of Southampton | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Rivermead Mobility Index Score | 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Swedish Postural Adjustment in Stroke Scale (SwePASS) | 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. | Week 0, 2 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer - Motor Leg Sub Section | Measure of sensori-motor function in the lower limb (impairment level) Range 0-28, with higher score indicating better outcome. | Week 0, week 2 and week 12 |
| Modified Rankin Score |
Inclusion Criteria:
Clinical diagnosis of stroke, presenting with hemiplegia
Within 14 days of stroke onset
Medically stable
Able to...
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise Johnson | University Hospitals Dorset | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Bournemouth Hospital | Bournemouth | Dorset | BH7 7DW | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37682841 | Derived | Johnson L, Mardo J, Demain S. Understanding implementation of a complex intervention in a stroke rehabilitation research trial: A qualitative evaluation using Normalisation Process Theory. PLoS One. 2023 Sep 8;18(9):e0282612. doi: 10.1371/journal.pone.0282612. eCollection 2023. | |
| 36306569 | Derived | 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. |
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Qualitative data has been shared via the publication with PlosOne, as part of their publishing requirements. Quantitative data will be made available, upon reasonable request, following publication of the final paper.
Following final paper publication and for the duration of the archiving period (10 years)
Will be assessed upon request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention. |
| FG001 | Implicit Learning Approach | Implicit Learning Approach: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
3 participants had withdrawn from the Implicit Learning Cohort prior to intervention starting due to symptom resolution and were not therefore included in analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention. |
| BG001 | Implicit Learning Approach |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Modified Rivermead Mobility Index Score | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
Serious Adverse events data were collected from consent until end of trial intervention period (discharge from hospital - an average of 31 days for control group and 34 days for intervention group).
3 participants withdrew prior to the start of the intervention in the implicit learning approach as their symptoms had resolved, therefore they were not included in analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louise Johnson | University Hospitals Dorset NHS Foundation Trust | 0300 019 4473 | Louise.Johnson@uhd.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2020 | Jul 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
Measure of disability and dependence in people who have suffered a stroke.
Score 0-6, with higher score indicating a worse outcome.
| Week 0, Week 12 |
| EuroQOL 5 D Questionnaire Index Score | 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. | 3 months |
| 31687935 | Derived | 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. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| COVID-19 Restrictions |
|
| Symptoms resolved |
|
Implicit Learning Approach: 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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Swedish Postural Adjustment in Stroke Scale (SwePASS) | 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. | Patients had withdrawn over at each time point in both interventions for different reasons including 2 further stroke, 1 did not attend, 5 affected by COVID-19 restrictions, 1 death and 1 patient choice withdrawal. 3 participants withdrew prior to the start of the intervention in the implicit learning approach as their symptoms had resolved, therefore they were not included in analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 0, 2 and 12 |
|
|
|
| Other Pre-specified | Fugl Meyer - Motor Leg Sub Section | Measure of sensori-motor function in the lower limb (impairment level) Range 0-28, with higher score indicating better outcome. | Patients had withdrawn over at each time point in both interventions for different reasons including 2 further stroke, 1 did not attend, 5 affected by COVID-19 restrictions, 1 death and 1 patient choice withdrawal. 3 participants withdrew prior to the start of the intervention in the implicit learning approach as their symptoms had resolved, therefore they were not included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 0, week 2 and week 12 |
|
|
|
| Other Pre-specified | Modified Rankin Score | Measure of disability and dependence in people who have suffered a stroke. Score 0-6, with higher score indicating a worse outcome. | Patients had withdrawn over at each time point in both interventions for different reasons including 2 further stroke, 1 did not attend, 5 affected by COVID-19 restrictions, 1 death and 1 patient choice withdrawal. 3 participants withdrew prior to the start of the intervention in the implicit learning approach as their symptoms had resolved, therefore they were not included in analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 12 |
|
|
|
| Other Pre-specified | EuroQOL 5 D Questionnaire Index Score | 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. | Patients had withdrawn over at each time point in both interventions for different reasons including 2 further stroke, 1 did not attend, 5 affected by COVID-19 restrictions, 1 death and 1 patient choice withdrawal. 3 participants withdrew prior to the start of the intervention in the implicit learning approach as their symptoms had resolved, therefore they were not included in analysis. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 0 |
| 30 |
| EG001 | Implicit Learning Approach | Implicit Learning Approach: 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. | 1 | 21 | 2 | 21 | 0 | 21 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Week 2 |
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| Week 12 |
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| Week 2 |
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| Week 12 |
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| Week 12 |
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