Effectiveness of FACoT for Individuals Post Stroke

NCT02925637 | Completed DMC

• 1 other identifier: adamit_t
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (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 Outcomes (11)

• 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)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (3)

• National Institutes of Health Stroke Scale (NIHSS)

  baseline (week 0)

• Functional Independence Measure (FIM)

  baseline (week 0)

• demographic questionnaire

  baseline (week 0)

Study Arms (2)

FACoT group

EXPERIMENTAL

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

control group

NO INTERVENTION

control group receiving standard care - cognitive and functional assesment

Interventions

FaCoT OTHER

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

FACoT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years
• at least three years post stroke
• severity mild to moderate (NIHSS≤5)
• independent prior to the stroke
• can understand and speak Hebrew

You may not qualify if:

• with no other neurological or psychiatric conditions
• without dementia

Sponsors & Collaborators

• Bait Balev Hospital: lead
• Tel Aviv University: collaborator

Study Sites (1)

Maccabi

Ashdod, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• tal adamit, PHD student

  Maccabbi health center ashdod isreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: October 6, 2016
• Study Start: March 12, 2017
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: April 14, 2021

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)