Effectiveness of FACoT for Individuals Post Stroke

Study Overview
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Brief Summary
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To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT) in occupational therapy for people after mild to moderate stroke.

Official Title
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Effectiveness of a Novel Meta-cognitive-functional Intervention (FACoT) for Individuals Post Mild-moderate Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: FaCoT


Participation Criteria
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Eligibility Criteria
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inclusion criteria: >18 years at least three years post stroke severity mild to moderate (NIHSS≤5) independent prior to the stroke can understand and speak Hebrew Exclusion Criteria: with no other neurological or psychiatric conditions without dementia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FACoT group<br>treatment group will receive FACoT, that include one to one 10 treatment sessions. the treatment sessions will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies | Other: FaCoT<br>* The intervention will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies<br>|
| No Intervention: control group<br>control group receiving standard care - cognitive and functional assesment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores of The Canadian Occupational Performance Measure (COPM) |  | Change between baseline (week 0) to time 1 (post-intervention -10-13 weeks later) and time 2 (follow-up- three month later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores of the Instrumental Activities of Daily Living (IADL) scale |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later) | 
| Change in scores of Reintegration to Normal Living Index (RNL) |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up-3 month later) | 
| Change in scores of Short Form-12v2 Health Survey (SF-12v2) |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later) | 
| change in scoe of New general self efficacy scale (NGSE) |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later) | 
| Change in scores of Patient competency rating scale (PCRS) |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later) | 
| Change in scores Self Regulation Skills Interview (SRSI) |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later) | 
| Change in scores of Montreal Cognitive Assessment (MoCA) |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up-3 month later) | 
| Change in scores of Trail making test (TMT) |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later) | 
| Change in scores of zoo-map |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up-3 month later) | 
| Change in scores of Dysexecutive Questionnaire (DEX) |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3month later) | 
| Geriatric Depression Scale - short form (GDS-SF) |  | Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3 month later) |