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Effectiveness of FACoT for Individuals Post Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
FaCoT
Sponsored by
Bait Balev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maccabi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FACoT group

control group

Arm Description

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

control group receiving standard care - cognitive and functional assesment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in scores of the Instrumental Activities of Daily Living (IADL) scale
Change in scores of Reintegration to Normal Living Index (RNL)
Change in scores of Short Form-12v2 Health Survey (SF-12v2)
change in scoe of New general self efficacy scale (NGSE)
Change in scores of Patient competency rating scale (PCRS)
Change in scores Self Regulation Skills Interview (SRSI)
Change in scores of Montreal Cognitive Assessment (MoCA)
Change in scores of Trail making test (TMT)
Change in scores of zoo-map
Change in scores of Dysexecutive Questionnaire (DEX)
Geriatric Depression Scale - short form (GDS-SF)

Full Information

First Posted
August 3, 2016
Last Updated
April 11, 2021
Sponsor
Bait Balev Hospital
Collaborators
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT02925637
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 12, 2017 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
February 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bait Balev Hospital
Collaborators
Tel Aviv University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FACoT group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
No Intervention
Arm Description
control group receiving standard care - cognitive and functional assesment
Intervention Type
Other
Intervention Name(s)
FaCoT
Intervention Description
The intervention will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change in scores of the Instrumental Activities of Daily Living (IADL) scale
Time Frame
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)
Title
Change in scores of Reintegration to Normal Living Index (RNL)
Time Frame
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)
Title
Change in scores of Short Form-12v2 Health Survey (SF-12v2)
Time Frame
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)
Title
change in scoe of New general self efficacy scale (NGSE)
Time Frame
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)
Title
Change in scores of Patient competency rating scale (PCRS)
Time Frame
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)
Title
Change in scores Self Regulation Skills Interview (SRSI)
Time Frame
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)
Title
Change in scores of Montreal Cognitive Assessment (MoCA)
Time Frame
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)
Title
Change in scores of Trail making test (TMT)
Time Frame
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)
Title
Change in scores of zoo-map
Time Frame
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)
Title
Change in scores of Dysexecutive Questionnaire (DEX)
Time Frame
Change between baseline (week 0) to time 1 (post-intervention, 10-13 weeks later) and between baseline to time 2 (follow-up- 3month later)
Title
Geriatric Depression Scale - short form (GDS-SF)
Time Frame
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 Pre-specified Outcome Measures:
Title
National Institutes of Health Stroke Scale (NIHSS)
Time Frame
baseline (week 0)
Title
Functional Independence Measure (FIM)
Time Frame
baseline (week 0)
Title
demographic questionnaire
Time Frame
baseline (week 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
tal adamit, PHD student
Organizational Affiliation
Maccabbi health center ashdod isreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maccabi
City
Ashdod
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of FACoT for Individuals Post Stroke

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