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Clinical Trials/NCT05098730
NCT05098730
Not Yet Recruiting
N/A

Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation

University of Haifa1 site in 1 country50 target enrollmentOctober 1, 2024
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Haifa
Enrollment
50
Locations
1
Primary Endpoint
Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The study will administer an intervention called strategy training to adult stroke survivors living in the community who do and do not have pets, and will examine the role of a pet in promoting cognitive performance and community participation outcomes.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
June 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Naor Demeter

Principal Investigator, Faculty Associate

University of Haifa

Eligibility Criteria

Inclusion Criteria

  • Primary diagnosis of acute stroke
  • At least 3 months after the stroke onset
  • Living in a community residence with a pet
  • Cognitive impairment as indicated by an Executive Interview score of 3 or higher
  • Participation restrictions as indicated by an Activity Card Sort (\<80% of pre-stroke activities)
  • Willing to participate in a 6-week program with 2 intervention sessions per week at home

Exclusion Criteria

  • Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower
  • Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1
  • Self-report of a central nervous system disorder other than stroke
  • Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview
  • Severe mental illness as indicated by the PRIME-MD
  • Prior exposure to strategy training
  • Currently participate in rehabilitation therapy programs
  • Stroke survivors without pets
  • Inclusion Criteria:
  • Primary diagnosis of acute stroke

Outcomes

Primary Outcomes

Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale

Time Frame: Baseline to 6 weeks

The scale is a valid and reliable criterion referenced measure that assesses engagement in rehabilitation therapy sessions. Each session is scored by the occupational therapist, 1 (no participation, refusal) to 6 (excellent participation). Scores are averaged across the 10-15 intervention sessions to generate the mean engagement score.

Secondary Outcomes

  • Change in attention as measured by the Color Trail Test 1(Baseline to 3 months)
  • Change in executive function as measured by the Color Trail Test 2(Baseline to 3 months)
  • Change in community participation as measure by Community Participation Indicators score(Baseline to 3 months)

Study Sites (1)

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