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NCT Number: NCT05098730

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Stroke survivors with pets

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
  • At least 3 months after the stroke onset
  • Living in a community residence
  • 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

Treatment and study plan

Strategy Training

Behavioral

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.

Primary outcomes

  1. 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

  1. Change in attention as measured by the Color Trail Test 1

    Time frame: 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.

  2. Change in executive function as measured by the Color Trail Test 2

    Time frame: 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.

  3. Change in community participation as measure by Community Participation Indicators score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Skidmore, PhD

CONTACT

[email protected]

4123836617

Naor Domotor, PhD

CONTACT

[email protected]

4123836617

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 28, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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