Trial Outcomes & Findings for Implicit Learning in Stroke Study (NCT NCT03792126)

NCT ID: NCT03792126

Last Updated: 2024-12-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2024-12-13

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	30	24
Overall Study COMPLETED	27	14
Overall Study NOT COMPLETED	3	10

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	1	2
Overall Study Death	0	1
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study COVID-19 Restrictions	1	3
Overall Study Symptoms resolved	0	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standard Care n=30 Participants Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention.	Implicit Learning Approach n=21 Participants 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.	Total n=51 Participants Total of all reporting groups
Age, Continuous	74 years STANDARD_DEVIATION 15 • n=30 Participants	73 years STANDARD_DEVIATION 12 • n=21 Participants	74 years STANDARD_DEVIATION 14 • n=51 Participants
Sex: Female, Male Female	15 Participants n=30 Participants	7 Participants n=21 Participants	22 Participants n=51 Participants
Sex: Female, Male Male	15 Participants n=30 Participants	14 Participants n=21 Participants	29 Participants n=51 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	30 participants n=30 Participants	21 participants n=21 Participants	51 participants n=51 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Standard Care n=27 Participants Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention.	Implicit Learning Approach n=14 Participants 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.
Change in Modified Rivermead Mobility Index Score	30.2 score on a scale Standard Deviation 11.6	34.4 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard Care n=30 Participants Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention.	Implicit Learning Approach n=21 Participants 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.
Swedish Postural Adjustment in Stroke Scale (SwePASS) Week 12	26.4 units on a scale Standard Deviation 7.8	29.1 units on a scale Standard Deviation 5.3
Swedish Postural Adjustment in Stroke Scale (SwePASS) Week 0	17.7 units on a scale Standard Deviation 6.2	19.3 units on a scale Standard Deviation 7.5
Swedish Postural Adjustment in Stroke Scale (SwePASS) Week 2	22.1 units on a scale Standard Deviation 6.8	23.9 units on a scale Standard Deviation 8.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

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

Outcome measures

Measure	Standard Care n=30 Participants Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention.	Implicit Learning Approach n=21 Participants 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.
Fugl Meyer - Motor Leg Sub Section Week 0	14.0 score on a scale Standard Deviation 7.6	11.5 score on a scale Standard Deviation 7.0
Fugl Meyer - Motor Leg Sub Section Week 2	17.65 score on a scale Standard Deviation 7.2	16.3 score on a scale Standard Deviation 9.7
Fugl Meyer - Motor Leg Sub Section Week 12	21.1 score on a scale Standard Deviation 8.0	24.9 score on a scale Standard Deviation 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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

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

Outcome measures

Measure	Standard Care n=30 Participants Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention.	Implicit Learning Approach n=21 Participants 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.
Modified Rankin Score Week 0	4 score on a scale Standard Deviation 0	3.96 score on a scale Standard Deviation 0.21
Modified Rankin Score Week 12	4 score on a scale Standard Deviation 0.9	2.6 score on a scale Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Standard Care n=27 Participants Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention.	Implicit Learning Approach n=14 Participants 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.
EuroQOL 5 D Questionnaire Index Score	12 score on a scale Standard Deviation 4	13.2 score on a scale Standard Deviation 4

Adverse Events

Standard Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Implicit Learning Approach

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Standard Care n=30 participants at risk Standard care clusters will not have access to the trial materials (e.g. treatment manual), or details about the specific elements of the intervention.	Implicit Learning Approach n=21 participants at risk 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.
Vascular disorders Stroke	3.3% 1/30 • Number of events 1 • 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.	9.5% 2/21 • Number of events 2 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Louise Johnson

University Hospitals Dorset NHS Foundation Trust

Phone: 0300 019 4473

Email: Louise.Johnson@uhd.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place