Back to resultsA Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stroke rehabilitative therapy sessions with therapy dog present
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Patients who have had a stroke (embolic or hemorrhagic)
- Patients actively being seen in the rehabilitation unit
- Patients aged 18 years or older
- Patients who are able and willing to give informed consent
- Patients who are able to speak English
- Patients who are able to complete questionnaires
- Patients who have no fear or allergy of dogs
Exclusion Criteria:
- Individuals who decline to participate in the study
- Individuals who have not suffered a stroke
- Individuals who are not willing or able to go through therapy sessions at least three times a week
- Individuals that are severely allergic to or fearful of dogs
- Individuals who are unable to speak English or complete the study questionnaires
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Therapy dog during stroke rehabilitative therapy sessions
No therapy dog during stroke rehabilitative therapy sessions
Arm Description
Participants randomized to this arm will have a therapy dog present during their stroke rehabilitative therapy sessions.
Participants randomized to this arm will have stroke rehabilitative therapy sessions per standard of care with no therapy dog present.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05046574
First Posted
September 7, 2021
Last Updated
June 1, 2023
Sponsor
Mayo Clinic
Collaborators
Purina Petcare
1. Study Identification
Unique Protocol Identification Number
NCT05046574
Brief Title
A Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Purina Petcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapy dog during stroke rehabilitative therapy sessions
Arm Type
Experimental
Arm Description
Participants randomized to this arm will have a therapy dog present during their stroke rehabilitative therapy sessions.
Arm Title
No therapy dog during stroke rehabilitative therapy sessions
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will have stroke rehabilitative therapy sessions per standard of care with no therapy dog present.
Intervention Type
Other
Intervention Name(s)
Stroke rehabilitative therapy sessions with therapy dog present
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Anxiety
Description
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.
Time Frame
Baseline through inpatient stay, an average of 2 weeks.
Title
Change in Depression
Description
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.
Time Frame
Baseline through inpatient stay, an average of 2 weeks.
Title
Change in Quality of Life Outcomes
Description
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.
Time Frame
Baseline through inpatient stay, an average of 2 weeks.
Title
Change in motivation
Description
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.
Time Frame
Baseline through inpatient stay, an average of 2 weeks.
Title
Change in overall functional recovery
Description
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.
Time Frame
Baseline through inpatient stay, an average of 2 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Department of Medicine - Research Hub
Phone
5072661944
Email
DOMRESEARCHHUB@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arya Mohabbat, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation
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