Stroke
Conditions
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.
Interventions
OTHERImplicit 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.
Sponsors
University of Southampton
The Royal Bournemouth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Rivermead Mobility Index Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Swedish Postural Adjustment in Stroke Scale (SwePASS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer - Motor Leg Sub Section | 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. |
| Modified Rankin Score | 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. |
| EuroQOL 5 D Questionnaire Index Score | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 21 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | COVID-19 Restrictions | 1 | 3 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Symptoms resolved | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Implicit Learning Approach | Total | Standard Care |
|---|---|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 12 | 74 years STANDARD_DEVIATION 14 | 74 years STANDARD_DEVIATION 15 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 21 participants | 51 participants | 30 participants |
| Sex: Female, Male Female | 7 Participants | 22 Participants | 15 Participants |
| Sex: Female, Male Male | 14 Participants | 29 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 1 / 21 |
| other Total, other adverse events | 0 / 30 | 0 / 21 |
| serious Total, serious adverse events | 1 / 30 | 2 / 21 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Modified Rivermead Mobility Index Score | 30.2 score on a scale | Standard Deviation 11.6 |
| Implicit Learning Approach | Change in Modified Rivermead Mobility Index Score | 34.4 score on a scale | Standard Deviation 7.5 |
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.
Time frame: Week 0, 2 and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | Swedish Postural Adjustment in Stroke Scale (SwePASS) | Week 0 | 17.7 units on a scale | Standard Deviation 6.2 |
| Standard Care | Swedish Postural Adjustment in Stroke Scale (SwePASS) | Week 2 | 22.1 units on a scale | Standard Deviation 6.8 |
| Standard Care | Swedish Postural Adjustment in Stroke Scale (SwePASS) | Week 12 | 26.4 units on a scale | Standard Deviation 7.8 |
| Implicit Learning Approach | Swedish Postural Adjustment in Stroke Scale (SwePASS) | Week 0 | 19.3 units on a scale | Standard Deviation 7.5 |
| Implicit Learning Approach | Swedish Postural Adjustment in Stroke Scale (SwePASS) | Week 2 | 23.9 units on a scale | Standard Deviation 8.1 |
| Implicit Learning Approach | Swedish Postural Adjustment in Stroke Scale (SwePASS) | Week 12 | 29.1 units on a scale | Standard Deviation 5.3 |
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | EuroQOL 5 D Questionnaire Index Score | 12 score on a scale | Standard Deviation 4 |
| Implicit Learning Approach | EuroQOL 5 D Questionnaire Index Score | 13.2 score on a scale | Standard Deviation 4 |
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.
Time frame: Week 0, week 2 and week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | Fugl Meyer - Motor Leg Sub Section | Week 0 | 14.0 score on a scale | Standard Deviation 7.6 |
| Standard Care | Fugl Meyer - Motor Leg Sub Section | Week 2 | 17.65 score on a scale | Standard Deviation 7.2 |
| Standard Care | Fugl Meyer - Motor Leg Sub Section | Week 12 | 21.1 score on a scale | Standard Deviation 8 |
| Implicit Learning Approach | Fugl Meyer - Motor Leg Sub Section | Week 0 | 11.5 score on a scale | Standard Deviation 7 |
| Implicit Learning Approach | Fugl Meyer - Motor Leg Sub Section | Week 2 | 16.3 score on a scale | Standard Deviation 9.7 |
| Implicit Learning Approach | Fugl Meyer - Motor Leg Sub Section | Week 12 | 24.9 score on a scale | Standard Deviation 6 |
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.
Time frame: Week 0, Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | Modified Rankin Score | Week 0 | 4 score on a scale | Standard Deviation 0 |
| Standard Care | Modified Rankin Score | Week 12 | 4 score on a scale | Standard Deviation 0.9 |
| Implicit Learning Approach | Modified Rankin Score | Week 0 | 3.96 score on a scale | Standard Deviation 0.21 |
| Implicit Learning Approach | Modified Rankin Score | Week 12 | 2.6 score on a scale | Standard Deviation 1 |