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Completed

NCT Number: NCT02925637

Effectiveness of FACoT for Individuals Post Stroke

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maccabi

Ashdod, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FaCoT

Other

The intervention will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies

Primary outcomes

  1. 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

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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 outcomes

  1. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: baseline (week 0)

  2. Functional Independence Measure (FIM)

    Time frame: baseline (week 0)

  3. demographic questionnaire

    Time frame: baseline (week 0)

Sponsors and collaborators

Lead sponsor

Bait Balev Hospital

Other

Collaborators

  • Tel Aviv University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 6, 2016
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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