StrokeNCT05098730
Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation
A study testing Strategy Training in people with Stroke, run by University of Haifa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Strategy Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Currently participate in rehabilitation therapy programs
- Stroke survivors without pets
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
Minmei Shih, PhD, OTR/L, 412-383-6752, mis235@pitt.edu
Elizabeth R Skidmore, PhD, OTR/L, (412) 383-6617, skidmore@pitt.edu
About this study
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.
- Conditions
- Stroke
- Being tested
- Strategy Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors with pets | Experimental | 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. Receives: Behavioral: Strategy Training |
| Stroke survivors without pets | Active comparator | 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. Receives: Behavioral: Strategy Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 weeks
Secondary outcomes (3)
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a single site, two-group quasi-experimental design comparing the effects of strategy training on rehabilitation engagement, cognitive performance, and community participation of home-dwelling stroke survivors living with and without pets. The investigators will also conduct qualitative interviews with participants who have pets.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naor Demeter, University of Haifa
- Investigators
- Naor Domotor, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098730
- Sponsor's protocol ID
- STUDY21080031
- Status last verified
- Aug 2024
- First submitted
- 15 Oct 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation
- ClinicalTrials.gov ID
- NCT05098730
- Acronym / sponsor ID
- STUDY21080031
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study is a single site, two-group quasi-experimental design comparing the effects of strategy training on rehabilitation engagement, cognitive performance, and community participation of home-dwelling stroke survivors living with and without pets. The investigators will also conduct qualitative interviews with participants who have pets.
| Arm | Type | Receives |
|---|---|---|
| Stroke survivors with pets | Experimental | Behavioral: Strategy TrainingStroke 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 | Active comparator | Behavioral: Strategy TrainingStroke survivors without pets will receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strategy TrainingStrategy 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. | Behavioural | Stroke survivors with pets, Stroke survivors without pets |
Primary outcome
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.
3 secondary outcomes
Change in attention as measured by the Color Trail Test 1
Time frame: Baseline to 3 months
Change in executive function as measured by the Color Trail Test 2
Time frame: Baseline to 3 months
Change in community participation as measure by Community Participation Indicators score
Time frame: Baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naor Domotor, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy Training in people with Stroke, run by University of Haifa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naor Domotor, PhD (4123836617, NAD129@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.