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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05098730
• Other study ID #: STUDY21080031
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2022
• Source: University of Pittsburgh
• Contact: Naor Domotor, PhD
• Phone: 4123836617
• Email: NAD129[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Stroke survivors with pets

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Strategy Training
Strategy training is comprised of participant-selected activity based goals, self evaluation, global problem solving strategies, and therapist-delivered guided training. The strategy training therapist will guide participants using prompting questions, as well as work sheets that facilitate learning and aid the participants in implementing the process.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale	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.	Baseline to 6 weeks
Secondary	Change in attention as measured by the Color Trail Test 1	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.	Baseline to 3 months
Secondary	Change in executive function as measured by the Color Trail Test 2	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.	Baseline to 3 months
Secondary	Change in community participation as measure by Community Participation Indicators score	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.	Baseline to 3 months