Effectiveness of FACoT for Individuals Post Stroke

• Sponsor: Bait Balev Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02925637
• Collaborator: Tel Aviv University (Other)
• Enrollment: 66
• Location: 1
• Arms: 2
• Actual Duration (Months): 35.5
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: FaCoT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of a Novel Meta-cognitive-functional Intervention (FACoT) for Individuals Post Mild-moderate Stroke
• Actual Study Start Date: Mar 12, 2017
• Actual Primary Completion Date: Feb 27, 2020
• Actual Study Completion Date: Feb 27, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)]

2. 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)]

3. 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)]

4. 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)]

5. 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)]

6. 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)]

7. 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)]

8. 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)]

9. 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)]

10. 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)]

11. 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)]

Other Outcome Measures

1. National Institutes of Health Stroke Scale (NIHSS) [baseline (week 0)]

2. Functional Independence Measure (FIM) [baseline (week 0)]

3. demographic questionnaire [baseline (week 0)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maccabi	Ashdod		Israel

Sponsors and Collaborators

• Bait Balev Hospital
• Tel Aviv University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bait Balev Hospital
• ClinicalTrials.gov Identifier: NCT02925637
• Other Study ID Numbers: adamit_t
• First Posted: Oct 6, 2016
• Last Update Posted: Apr 14, 2021
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Apr 14, 2021