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

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Behavioral: Strategy Training

• Registration Number: NCT05098730
• Lead Sponsor: University of Haifa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Study Start: 2024-10-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

1. Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower
2. Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1
3. Self-report of a central nervous system disorder other than stroke
4. Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview
5. Severe mental illness as indicated by the PRIME-MD
6. Prior exposure to strategy training
7. Currently participate in rehabilitation therapy programs

Stroke survivors without pets

Inclusion Criteria:

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

Exclusion Criteria:

1. Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower
2. Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1
3. Self-report of a central nervous system disorder other than stroke
4. Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview
5. Severe mental illness as indicated by the PRIME-MD
6. Prior exposure to strategy training
7. Currently participate in rehabilitation therapy programs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stroke survivors with pets	Strategy Training	Stroke survivors with pets will receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home.
Stroke survivors without pets	Strategy Training	Stroke survivors without pets will receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home.

Primary Outcome Measures

Name	Time	Method
Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale	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 Outcome Measures

Name	Time	Method
Change in attention as measured by the Color Trail Test 1	Baseline to 3 months	This measure assesses perceptual tracking, sustained attention and grapho-motor skills. It is a pencil and paper, timed test. Completion time in seconds for each task is recorded, with a lower score representing better function. Change in attention will be calculated by subtracting the time to do the task at baseline from the time to do the task at 3 months.
Change in executive function as measured by the Color Trail Test 2	Baseline to 3 months	This measure assesses divided attention and sequencing skills, which are executive function performance. It is a pencil and paper, timed test of effortful executive processing abilities that assesses the ability to alternate between two colors. Completion time in seconds for each task is recorded, with a lower score representing better function. Change in executive function will be calculated by subtracting the time to do the task at baseline from the time to do the task at 3 months.
Change in community participation as measure by Community Participation Indicators score	Baseline to 3 months	This participant reported questionnaire will measure the frequency of community participation over a 7 days period. Each item is measured on a 5-point Likert scale, with 1=no participation in that activity and 5=7 days of participation in that activity. A total of 20 items are summed to yield a total score. Change in community participation will be calculated by subtracting baseline total score from the 3 month total score.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States