Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke: A Phase II Clinical Trial.
Brief Summary: Novel stroke rehabilitation approaches, such as task-specific training (TST), have shown promise in improving stroke recovery components such as basic mobility and activities of daily living; however, evidence suggests these improvements are not generalized and transferred to home, community, or work settings, and usually do not impact overall participation outcomes. Further, these treatments are very intense, with total treatment times as high as 30 to 60 hours, making them clinically or economically unfeasible in many settings. In contrast, approaches incorporating cognitive strategy training have shown great promise to not only improve functional activity performance in people living with stroke, but also to facilitate generalization and transfer beyond the clinical setting, and to do so in 10 to 15 treatment hours. Cognitive Orientation to daily Occupational Performance (CO-OP) is an established treatment approach that uses cognitive strategies in combination with TST. Evidence from other research groups and findings from our own participant interview data indicate that the approach may be even more effective if introduced much earlier in the rehabilitation process, however, CO-OP has not yet been tested in this sub-acute population. Therefore, the specific project goals are: 1. To refine the CO-OP treatment approach for use with people less than three months post stroke; 2. To evaluate, in a Phase II clinical trial, the preliminary efficacy of the refined protocol compared to standard occupational therapy on immediate and longer-term skill performance and participation; 3. To determine effect sizes for power calculations for a future Phase III clinical trial to test the new protocol versus contemporary treatment. The research approach consists of Part 1, Protocol Refinement, and Part 2, Exploratory Phase II Clinical Trial.


Options:
A: Inclusion Criteria:

1. age 18 or older;
2. have completed all physician recommended rehabilitation and currently not receiving rehabilitation services;
3. at least one-month post-stroke;
4. have self-reported unmet functional goals; and
5. NIH Stroke Scale (NIHSS) total score of 2-12.

Exclusion Criteria:

1. have sustained a hemorrhagic stroke;
2. NIH Stroke Scale (NIHSS) aphasia rating of 1 or more (impaired speech);
3. MoCA cognitive screen score of less than 21 (impaired general cognitive ability);
4. neurological diagnoses other than stroke;
5. major psychiatric illness (bipolar disorder, OCD, panic disorder, PTSD, and/or borderline personality disorder);
6. no major depressive symptoms (PHQ-9 \< 20);
7. a score of 6 or less on the CIHI aphasia screen combined items 64 and 66;
8. terminal illness;
9. blindness; and
10. non-English speaking.
B: Inclusion Criteria:

* diagnosis of stroke or TIA has been confirmed.
* newly referred to and eligible for home care services (physiotherapy, speech language therapy, occupational therapy, nursing) through the Toronto Central CCAC.
* living at home in the community (outside of an institutional setting) up to 18-months post-stroke.
* English speaking

Exclusion Criteria:

* refuse to give informed consent.
* more than 18 months post-stroke at time of recruitment.
* unable to read/write English and an appropriate translator is not available.
C: Inclusion Criteria:

* Aged 18 years of age or greater
* Admitted to out-patient rehabilitation post ischemic stroke

Exclusion Criteria:

* more than 6 months post stroke onset
* those not requiring occupational therapy
* hemorrhagic stroke
* neurological diagnoses other than stroke
* major psychiatric illness
* moderate or severe aphasia (NIH Stroke Scale aphasia rating of 2 or more)
* dementia (Mini Mental State Exam scores of 24 or less)
D: Inclusion Criteria:

* Symptomatic ischemic stroke with clinical syndrome of stroke and a corresponding ischemic lesion.
* MRI or CT results compatible with clinical diagnosis of acute ischemic stroke
* NIH Stroke Scale Score on admission 1 to 14, both inclusive
* Modified Rankin Scale before stroke 0 to 2, inclusive
* Randomization within 3 months after stroke onset (goal: 80% within 3 weeks)
* Sufficient communication possible
* Informed consent given by the patient and/or the patient's legally acceptable representative

Exclusion Criteria:

* Substantial cognitive decline (Mini Mental State Examination (MMSE) score \> 24) or pre-existing dementia or Parkinson disease
* Persistent disturbed level of consciousness
* Persistent aphasia
* Pre-existing significant psychiatric diseases (i.e. Schizophrenia, Major Depression, Bipolar Disorders, all according to DSMIV); Patients with minor Depression (DSM IV) can be included
* Severe sensory impairment making neuropsychological testing impossible
* Severe comorbidity (e.g. unstable or severe cardiovascular or pulmonal disease, neoplasm, severe liver or renal insufficiency and symptomatic stenosis of the ipsilateral carotid artery, cancer...)
* Unreliability for follow up
* Unwillingness or inability to participate or to sign the informed consent

Answer: C