Effectiveness of FACoT for Individuals Post Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02925637
• Other study ID #: adamit_t
• Status: Completed
• Phase: N/A
• Start date: March 12, 2017
• Est. completion date: February 27, 2020

Study information

• Verified date: February 2019
• Source: Bait Balev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Israel	Maccabi	Ashdod

Sponsors (2)

Lead Sponsor	Collaborator
Bait Balev Hospital	Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	National Institutes of Health Stroke Scale (NIHSS)		baseline (week 0)
Other	Functional Independence Measure (FIM)		baseline (week 0)
Other	demographic questionnaire		baseline (week 0)
Primary	Change in scores of The Canadian Occupational Performance Measure (COPM)		Change between baseline (week 0) to time 1 (post-intervention -10-13 weeks later) and time 2 (follow-up- three month later)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)