Effectiveness of FACoT for Individuals Post Stroke

April 11, 2021 updated by: Bait Balev Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashdod, Israel
        • Maccabi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FACoT group
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
The intervention will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies
No Intervention: control group
control group receiving standard care - cognitive and functional assesment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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
Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure
Time Frame
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: baseline (week 0)
baseline (week 0)
Functional Independence Measure (FIM)
Time Frame: baseline (week 0)
baseline (week 0)
demographic questionnaire
Time Frame: baseline (week 0)
baseline (week 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bait Balev Hospital

Collaborators

Tel Aviv University

Investigators

  • Principal Investigator: tal adamit, PHD student, Maccabbi health center ashdod isreal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2017

Primary Completion (Actual)

February 27, 2020

Study Completion (Actual)

February 27, 2020

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

October 5, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • adamit_t

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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