StrokeStrokeCog-RNCT06021470
The StrokeCog Study: Cognitive Rehabilitation Intervention in Stroke
A study testing Cognitive rehabilitation intervention in people with Stroke and Stroke Sequelae, run by Royal College of Surgeons, Ireland.
Trial summary
This study aims to progress to the next stage of feasibility testing, by conducting a pilot randomised controlled study with consecutive stroke patients who have mild to moderate cognitive impairment following stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Stroke Sequelae, Cognitive Impairment
- What is being tested?
- Cognitive rehabilitation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WHO-defined stroke, to include ICD-10 codes 160 (subarachnoid haemorrhage), 161 (intracerebral haemorrhage), 163 (cerebral infarction) including sub-categories, and 164 (stroke not specified as haemorrhage or infarction);
- First-ever and recurrent stroke;
- Age 18 and over (no upper age limit);
- Community dwelling (i.e., normal place of residence is not in a long-term care facility)
- Is a resident in the Republic of Ireland
- Capable of providing informed consent
Who cannot join
- Transient ischaemic attack;
- Aphasia;
- Poor English language ability;
- Nursing home resident;
- Dementia or severe cognitive impairment;
- Neurodegenerative disorder;
- Current psychiatric disorder (as defined by DSM-V or ICD-II criteria);
- Terminal illness.
Trial locations and contacts
No sites are listed yet.
Anne Hickey, PhD contact
About this study
Official title: The StrokeCog Study: a Randomised Pilot Study of a Novel Cognitive Rehabilitation Intervention in Stroke
This study aims to progress to the next stage of feasibility testing, by conducting a pilot randomised controlled study with consecutive stroke patients who have mild to moderate cognitive impairment following stroke. The primary focus of the proposed randomised pilot RCT is on recruitment and retention of patients in the intervention, and follow-up assessments. The researchers will also investigate outcomes associated with the intervention and the anticipated effect size for powering a larger trial, with a focus on the feasibility of implementing the intervention in a future definitive randomised controlled trial. The researchers will also carry out a study within a trial (SWAT), comparing recruitment and retention rates across acute, rehabilitation and chronic stroke settings.
Read the detailed description
Stroke is a leading cause of death and disability in Ireland and worldwide. Many people are aware of the physical disabilities that occur following stroke, but are less aware of the cognitive problems that people experience. Cognitive problems, or cognitive impairment, include difficulties with thinking, memory and concentration. They affect up to 60% of people after stroke. Stroke survivors and their families describe cognitive impairment as one of the most difficult stroke outcomes to deal with, and the biggest obstacle to returning to pre-stroke life.
Rehabilitation of post-stroke cognitive impairment has received little attention compared with physical rehabilitation. Current evidence indicates that cognitive impairment continues to decline and - especially if the person has another stroke - develops into dementia, one of the main reasons people move to long-term, or nursing home, care (LTC). Intervening to rehabilitate cognitive impairment may halt further decline and/or improve cognitive function, thus improving quality of life, and preventing progression to dementia and LTC.
The StrokeCog research team has developed a cognitive intervention based on extensive review of international studies and in-depth consultation with people who have had a stroke, their family members, and healthcare professionals working with people following stroke. The researchers have already tested this intervention with a very small number of patients with stroke-related cognitive impairment. Working with patient representatives, this research programme seeks to further test this intervention with a larger sample of patients with stroke-related cognitive problems. The researchers will collect information on the best way to recruit patients into the study, how many complete the intervention, and examine initial results on the benefits of the intervention. The team will collect and analyse detailed information on the costs associated with delivering this intervention. The study will provide strong evidence on whether the intervention is worthy of further investigation in a larger-scale research trial.
- Conditions
- Stroke, Stroke Sequelae, Cognitive Impairment
- Being tested
- Cognitive rehabilitation intervention
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive rehabilitation interventionBehavioural
The intervention comprises a five-week group-based cognitive rehabilitation intervention delivered by a clinical neuropsychologist, with home activities tailored to each stroke survivor's identified goals. Sessions involve four patients and are delivered once per week lasting 2.5 hours with breaks.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive rehabilitation intervention arm | Experimental | Five-week group-based and largely interactive format, with groups of four patients. Short presentations are delivered by the clinical neuropsychologist relating to psychoeducation and adjustment to stroke-related deficits in executive function, attention, and memory, respectively, and strategies addressing the activities and participation levels of functioning. Each session lasts approximately 2.5 hours, with a break in the middle. Tailored home activities are included for completion between group sessions to encourage self-efficacy and generalisation of skills and strategies. A member of the research team contacts all participants by telephone twice a week to assess engagement and reported self-efficacy in managing cognitive difficulties. In addition, a weekly text message is sent to all participants. In the proposed pilot RCT, for those receiving the intervention, the text message will contain tips on implementing compensatory strategies. Receives: Behavioral: Cognitive rehabilitation intervention |
| Usual care | No intervention | Those in the control group will be allocated to usual care from their multidisciplinary rehabilitation team in both acute and rehabilitation settings. Usual rehabilitation care is likely to vary across hospital settings (acute vs. rehabilitation). Information about type, dose, and amount of rehabilitation therapy will be captured from patients' medical charts in both the intervention and control arm of the study. A member of the research team (RA) contacts all participants by telephone twice a week to assess engagement and reported self-efficacy in managing cognitive difficulties. In addition, a weekly text message is sent to all participants. For those in the wait-list control condition, the text message will contain a positive affirmation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digit Span forward & backward (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Verbal Fluency (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Colour Trails Tests A&B (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
15-Item modified Boston Naming Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Symbol Digit Modalities Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Rey Complex Figure Test copy, immediate/delayed recall, and recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Hopkins Verbal Learning Test - immediate/delayed recall, & recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Secondary outcomes (14)
Goal Attainment Scaling based on SEIQoL (Self-efficacy in managing cognitive deficits)
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits.
Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Modified Stroke Self-Efficacy Scale (Self-efficacy in managing cognitive deficits)
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits.
Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Test of Premorbid Functioning
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits.
Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Wechsler Abbreviated Scale of Intelligence
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits.
Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Fatigue Severity Scale
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits.
Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
General Anxiety Disorder 7-item assessment
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits.
Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Patient Health Questionnaire
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits.
Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Modified Rankin Scale
A major secondary outcome is patient-reported self-efficacy in managing their cognitive deficits.
Additionally, personal and demographic details will be recorded for each patient. Mood, functional ability, quality of life (QoL), adherence, and recurrent stroke will be assessed as important secondary outcome measures.
Measured: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Patient Health Questionnaire (Family member/carer outcome)
The patient's family member/carer will be asked to complete a relative/carer assessment.
Measured: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
General Anxiety Disorder 7-item assessment (Family member/carer outcome)
The patient's family member/carer will be asked to complete a relative/carer assessment.
Measured: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Vulnerable Elders Survey (Family member/carer outcome)
The patient's family member/carer will be asked to complete a relative/carer assessment.
Measured: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Zarit Burden Interview (Family member/carer outcome)
The patient's family member/carer will be asked to complete a relative/carer assessment.
Measured: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Perceived Stress Scale (Family member/carer outcome)
The patient's family member/carer will be asked to complete a relative/carer assessment.
Measured: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Informant Questionnaire for Cognitive Decline in the Elderly, short form (Family member/carer outcome)
The patient's family member/carer will be asked to complete a relative/carer assessment.
Measured: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study startAug 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021470
- Sponsor's protocol ID
- StrokeCog-R
- Acronym
- StrokeCog-R
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The StrokeCog Study: a Randomised Pilot Study of a Novel Cognitive Rehabilitation Intervention in Stroke
- ClinicalTrials.gov ID
- NCT06021470
- Acronym / sponsor ID
- StrokeCog-R / StrokeCog-R
- Conditions
- Stroke, Stroke Sequelae, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to progress to the next stage of feasibility testing, by conducting a pilot randomised controlled study with consecutive stroke patients who have mild to moderate cognitive impairment following stroke. The primary focus of the proposed randomised pilot RCT is on recruitment and retention of patients in the intervention, and follow-up assessments. The researchers will also investigate outcomes associated with the intervention and the anticipated effect size for powering a larger trial, with a focus on the feasibility of implementing the intervention in a future definitive randomised controlled trial. The researchers will also carry out a study within a trial (SWAT), comparing recruitment and retention rates across acute, rehabilitation and chronic stroke settings.
Detailed description
Stroke is a leading cause of death and disability in Ireland and worldwide. Many people are aware of the physical disabilities that occur following stroke, but are less aware of the cognitive problems that people experience. Cognitive problems, or cognitive impairment, include difficulties with thinking, memory and concentration. They affect up to 60% of people after stroke. Stroke survivors and their families describe cognitive impairment as one of the most difficult stroke outcomes to deal with, and the biggest obstacle to returning to pre-stroke life.
Rehabilitation of post-stroke cognitive impairment has received little attention compared with physical rehabilitation. Current evidence indicates that cognitive impairment continues to decline and - especially if the person has another stroke - develops into dementia, one of the main reasons people move to long-term, or nursing home, care (LTC). Intervening to rehabilitate cognitive impairment may halt further decline and/or improve cognitive function, thus improving quality of life, and preventing progression to dementia and LTC.
The StrokeCog research team has developed a cognitive intervention based on extensive review of international studies and in-depth consultation with people who have had a stroke, their family members, and healthcare professionals working with people following stroke. The researchers have already tested this intervention with a very small number of patients with stroke-related cognitive impairment. Working with patient representatives, this research programme seeks to further test this intervention with a larger sample of patients with stroke-related cognitive problems. The researchers will collect information on the best way to recruit patients into the study, how many complete the intervention, and examine initial results on the benefits of the intervention. The team will collect and analyse detailed information on the costs associated with delivering this intervention. The study will provide strong evidence on whether the intervention is worthy of further investigation in a larger-scale research trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive rehabilitation intervention arm | Experimental | Behavioral: Cognitive rehabilitation interventionFive-week group-based and largely interactive format, with groups of four patients. Short presentations are delivered by the clinical neuropsychologist relating to psychoeducation and adjustment to stroke-related deficits in executive function, attention, and memory, respectively, and strategies addressing the activities and participation levels of functioning. Each session lasts approximately 2.5 hours, with a break in the middle. Tailored home activities are included for completion between group sessions to encourage self-efficacy and generalisation of skills and strategies. A member of the research team contacts all participants by telephone twice a week to assess engagement and reported self-efficacy in managing cognitive difficulties. In addition, a weekly text message is sent to all participants. In the proposed pilot RCT, for those receiving the intervention, the text message will contain tips on implementing compensatory strategies. |
| Usual care | No intervention | –Those in the control group will be allocated to usual care from their multidisciplinary rehabilitation team in both acute and rehabilitation settings. Usual rehabilitation care is likely to vary across hospital settings (acute vs. rehabilitation). Information about type, dose, and amount of rehabilitation therapy will be captured from patients' medical charts in both the intervention and control arm of the study. A member of the research team (RA) contacts all participants by telephone twice a week to assess engagement and reported self-efficacy in managing cognitive difficulties. In addition, a weekly text message is sent to all participants. For those in the wait-list control condition, the text message will contain a positive affirmation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- WHO-defined stroke, to include ICD-10 codes 160 (subarachnoid haemorrhage), 161 (intracerebral haemorrhage), 163 (cerebral infarction) including sub-categories, and 164 (stroke not specified as haemorrhage or infarction);
- First-ever and recurrent stroke;
- Age 18 and over (no upper age limit);
- Community dwelling (i.e., normal place of residence is not in a long-term care facility)
- Is a resident in the Republic of Ireland
Key exclusion criteria (8 listed)
- Transient ischaemic attack;
- Aphasia;
- Poor English language ability;
- Nursing home resident;
- Dementia or severe cognitive impairment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive rehabilitation interventionThe intervention comprises a five-week group-based cognitive rehabilitation intervention delivered by a clinical neuropsychologist, with home activities tailored to each stroke survivor's identified goals. Sessions involve four patients and are delivered once per week lasting 2.5 hours with breaks. | Behavioural | Cognitive rehabilitation intervention arm |
Primary outcome
Digit Span forward & backward (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Verbal Fluency (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Colour Trails Tests A&B (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
15-Item modified Boston Naming Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Symbol Digit Modalities Test (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Rey Complex Figure Test copy, immediate/delayed recall, and recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
Hopkins Verbal Learning Test - immediate/delayed recall, & recognition (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery)
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
The primary outcome is cognitive function, assessed using the standardised National Institute of Neurological Disorders \& Stroke (NINDS) Assessment battery. The primary outcome will be used for purposes of estimating the effect size (including standard deviation) to inform a power calculation for estimation of sample size for a definitive trial.
14 secondary outcomes
Goal Attainment Scaling based on SEIQoL (Self-efficacy in managing cognitive deficits)
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Modified Stroke Self-Efficacy Scale (Self-efficacy in managing cognitive deficits)
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Test of Premorbid Functioning
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Wechsler Abbreviated Scale of Intelligence
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Fatigue Severity Scale
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
General Anxiety Disorder 7-item assessment
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Patient Health Questionnaire
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Modified Rankin Scale
Time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Patient Health Questionnaire (Family member/carer outcome)
Time frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
General Anxiety Disorder 7-item assessment (Family member/carer outcome)
Time frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Vulnerable Elders Survey (Family member/carer outcome)
Time frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Zarit Burden Interview (Family member/carer outcome)
Time frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Perceived Stress Scale (Family member/carer outcome)
Time frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Informant Questionnaire for Cognitive Decline in the Elderly, short form (Family member/carer outcome)
Time frame: Carers/family members will complete these assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Hickey, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive rehabilitation intervention in people with Stroke and Stroke Sequelae, run by Royal College of Surgeons, Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Hickey, PhD (ahickey@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digit Span forward & backward (National Institute of Neurological Disorders & Stroke (NINDS) Assessment Battery) (time frame: Patients will complete these cognitive assessments at three time points: prior to (1) and following (2) the 5-week group based rehabilitation period (or control period), and at four months post-intervention (3).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.