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Clinical Trials/NCT02925637
NCT02925637CompletedNot Applicable

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

Bait Balev Hospital1 site in 1 country66 target enrollmentStarted: March 12, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
66
Locations
1
Primary Endpoint
Change in scores of The Canadian Occupational Performance Measure (COPM)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Change in scores of The Canadian Occupational Performance Measure (COPM)

Time Frame: Change between baseline (week 0) to time 1 (post-intervention -10-13 weeks later) and time 2 (follow-up- three month later)

Secondary Outcomes

  • 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 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 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 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 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))

Investigators

Sponsor
Bait Balev Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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