Stroke
Conditions
Brief summary
To develop and assess the effectiveness of a novel cognitive-functional intervention (FACoT) in occupational therapy for people after mild to moderate stroke.
Interventions
OTHERFaCoT
The intervention will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies
Sponsors
Tel Aviv University
Bait Balev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 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) |
| 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 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) |
Other
| Measure | Time frame |
|---|---|
| demographic questionnaire | baseline (week 0) |
| National Institutes of Health Stroke Scale (NIHSS) | baseline (week 0) |
| Functional Independence Measure (FIM) | baseline (week 0) |
Countries
Israel
Outcome results
None listed