StrokeNCT05046574
A Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation
A study testing Stroke rehabilitative therapy sessions with therapy dog present in people with Stroke, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical treatment for patients currently enrolled in the Mayo Clinic Stroke Rehabilitation Unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Stroke rehabilitative therapy sessions with therapy dog present
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2023to 21 Feb 2024
- 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
- Patient must be 18 years of age or older.
- Patient must be in the comprehensive in-patient stroke rehabilitation program.
- Patient must have a stroke from any cause.
- Patients must be able and willing to give informed consent.
- Patients must be able to speak English as the questionnaires being used are only available in English.
Who cannot join
- Patient who has a pacemaker.
- Patient who is pregnant.
- Patient who is deemed inappropriate to the study by the medical professional.
- Patient who is unable to give informed consent.
- Patient who is unable to speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Integrating Animal-assisted Therapy in Stroke Rehabilitation: a Randomized Controlled Trial Assessing the Impact on Psychological State and Functional Recovery of Patients, as Well as Wellbeing of Therapy Dogs
The investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical treatment for patients currently enrolled in the Mayo Clinic Stroke Rehabilitation Unit.
Read the detailed description
The objectives of this study are to measure the effects of a therapy dog embedded in stroke rehabilitation sessions on the patients' functional recovery, depression, anxiety, motivation, and quality of life.
- Conditions
- Stroke
- Being tested
- Stroke rehabilitative therapy sessions with therapy dog present
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke rehabilitative therapy sessions with therapy dog presentOther
Therapy dog will be present during stroke rehabilitative therapy sessions. This is expected to be at least three times a week per 7-day period.
| Study group | Role | What they receive |
|---|---|---|
| Therapy dog during stroke rehabilitative therapy sessions | Experimental | Participants randomized to this arm will have a therapy dog present during their stroke rehabilitative therapy sessions. Receives: Other: Stroke rehabilitative therapy sessions with therapy dog present |
| No therapy dog during stroke rehabilitative therapy sessions | No intervention | Participants randomized to this arm will have stroke rehabilitative therapy sessions per standard of care with no therapy dog present. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety
Change in anxiety from admission to discharge of hospital stay through use of the General Anxiety Disorder scale (GAD-7). GAD-7 scores range from 0 to 21 with higher scores indicating greater severity of anxiety.
Measured: Baseline through inpatient stay, an average of 2 weeks.
Change in Depression
Change in depression from admission to discharge of hospital stay through the use of the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 scores range from 0 to 27 with higher scores indicating greater severity of depression.
Measured: Baseline through inpatient stay, an average of 2 weeks.
Change in Quality of Life Outcomes
Change in quality of life outcomes from admission to discharge of hospital stay through the use of the Stroke Specific Quality of Life Scale (SSQLS). The SSQL has 49 items that covers 12 domains. The SSQL scores range from 49 to 245 with higher scores indicating a better health related quality of life.
Measured: Baseline through inpatient stay, an average of 2 weeks.
Change in motivation
Change in motivation from admission to discharge of hospital stay through the use of the Pittsburgh Rehabilitation Participation Scale (PRRS). The PRRS is a clinician-rated instrument used to evaluate patients' participation in therapy. This questionnaire contains one item, asking therapists to rate the patient's effort and motivation during the therapy session based on a 6-point scale.
Measured: Baseline through inpatient stay, an average of 2 weeks.
Change in overall functional recovery
Change in overall functional recovery from admission to discharge of hospital stay through the use of the Self-Care and Mobility Quality Measures (SMQM). The SMQM is a clinician-rated instrument used to measure self-care and mobility measures. The clinician rates each item on a 6-point scale. A higher domain score indicates that the patient has a better independency in the functional performance of that domain.
Measured: Baseline through inpatient stay, an average of 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start20 Feb 2023
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Purina Petcare
- Responsible party
- Principal investigator, Arya B. Mohabbat, M.D., Mayo Clinic
- Investigators
- Arya Mohabbat, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046574
- Sponsor's protocol ID
- 21-005175
- Status last verified
- Apr 2024
- First submitted
- 7 Sep 2021
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Animal-assisted Therapy in Stroke Rehabilitation: a Randomized Controlled Trial Assessing the Impact on Psychological State and Functional Recovery of Patients, as Well as Wellbeing of Therapy Dogs
- ClinicalTrials.gov ID
- NCT05046574
- Acronym / sponsor ID
- 21-005175
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Purina Petcare
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 16 Sep 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 investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical treatment for patients currently enrolled in the Mayo Clinic Stroke Rehabilitation Unit.
Detailed description
The objectives of this study are to measure the effects of a therapy dog embedded in stroke rehabilitation sessions on the patients' functional recovery, depression, anxiety, motivation, and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy dog during stroke rehabilitative therapy sessions | Experimental | Other: Stroke rehabilitative therapy sessions with therapy dog presentParticipants randomized to this arm will have a therapy dog present during their stroke rehabilitative therapy sessions. |
| No therapy dog during stroke rehabilitative therapy sessions | No intervention | –Participants randomized to this arm will have stroke rehabilitative therapy sessions per standard of care with no therapy dog present. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must be 18 years of age or older.
- Patient must be in the comprehensive in-patient stroke rehabilitation program.
- Patient must have a stroke from any cause.
- Patients must be able and willing to give informed consent.
- Patients must be able to speak English as the questionnaires being used are only available in English.
Key exclusion criteria (5 listed)
- Patient who has a pacemaker.
- Patient who is pregnant.
- Patient who is deemed inappropriate to the study by the medical professional.
- Patient who is unable to give informed consent.
- Patient who is unable to speak English.
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 |
|---|---|---|
| Stroke rehabilitative therapy sessions with therapy dog presentTherapy dog will be present during stroke rehabilitative therapy sessions. This is expected to be at least three times a week per 7-day period. | Other | Therapy dog during stroke rehabilitative therapy sessions |
Primary outcome
Change in Anxiety
Time frame: Baseline through inpatient stay, an average of 2 weeks.
Change in anxiety from admission to discharge of hospital stay through use of the General Anxiety Disorder scale (GAD-7). GAD-7 scores range from 0 to 21 with higher scores indicating greater severity of anxiety.
Change in Depression
Time frame: Baseline through inpatient stay, an average of 2 weeks.
Change in depression from admission to discharge of hospital stay through the use of the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 scores range from 0 to 27 with higher scores indicating greater severity of depression.
Change in Quality of Life Outcomes
Time frame: Baseline through inpatient stay, an average of 2 weeks.
Change in quality of life outcomes from admission to discharge of hospital stay through the use of the Stroke Specific Quality of Life Scale (SSQLS). The SSQL has 49 items that covers 12 domains. The SSQL scores range from 49 to 245 with higher scores indicating a better health related quality of life.
Change in motivation
Time frame: Baseline through inpatient stay, an average of 2 weeks.
Change in motivation from admission to discharge of hospital stay through the use of the Pittsburgh Rehabilitation Participation Scale (PRRS). The PRRS is a clinician-rated instrument used to evaluate patients' participation in therapy. This questionnaire contains one item, asking therapists to rate the patient's effort and motivation during the therapy session based on a 6-point scale.
Change in overall functional recovery
Time frame: Baseline through inpatient stay, an average of 2 weeks.
Change in overall functional recovery from admission to discharge of hospital stay through the use of the Self-Care and Mobility Quality Measures (SMQM). The SMQM is a clinician-rated instrument used to measure self-care and mobility measures. The clinician rates each item on a 6-point scale. A higher domain score indicates that the patient has a better independency in the functional performance of that domain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Arya Mohabbat, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke rehabilitative therapy sessions with therapy dog present in people with Stroke, run by Mayo Clinic 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 1 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety (time frame: Baseline through inpatient stay, an average of 2 weeks.). The study lists 5 primary outcomes in all. 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 1 May 2024.