Clinical trial NCT02925637: Effectiveness of FACoT for Individuals Post Stroke
Official title: Effectiveness of a Novel Meta-cognitive-functional Intervention (FACoT) for Individuals Post Mild-moderate Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Bait Balev Hospital
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2016-10-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in scores of The Canadian Occupational Performance Measure (COPM)
timeFrame: Change between baseline (week 0) to time 1 (post-intervention -10-13 weeks later) and time 2 (follow-up- three month later)
Secondary outcomes:
measure: Change in scores of the Instrumental Activities of Daily Living (IADL) scale
timeFrame: 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)
measure: Change in scores of Reintegration to Normal Living Index (RNL)
timeFrame: 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)
measure: Change in scores of Short Form-12v2 Health Survey (SF-12v2)
timeFrame: 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)
measure: change in scoe of New general self efficacy scale (NGSE)
timeFrame: 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)
measure: Change in scores of Patient competency rating scale (PCRS)
timeFrame: 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)
measure: Change in scores Self Regulation Skills Interview (SRSI)
timeFrame: 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)
measure: Change in scores of Montreal Cognitive Assessment (MoCA)
timeFrame: 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)
measure: Change in scores of Trail making test (TMT)
timeFrame: 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)
measure: Change in scores of zoo-map
timeFrame: 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)
measure: Change in scores of Dysexecutive Questionnaire (DEX)
timeFrame: Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3month later)
measure: Geriatric Depression Scale - short form (GDS-SF)
timeFrame: 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 outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: baseline (week 0)
measure: Functional Independence Measure (FIM)
timeFrame: baseline (week 0)
measure: demographic questionnaire
timeFrame: baseline (week 0)
Locations:
city: Ashdod
country: Israel
facility: Maccabi
Study officials:
affiliation: Maccabbi health center ashdod isreal
name: tal adamit, PHD student
role: PRINCIPAL_INVESTIGATOR
References: