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A Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05046574
Enrollment
52
Registered
2021-09-16
Start date
2023-02-20
Completion date
2024-02-21
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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.

Interventions

OTHERStroke rehabilitative therapy sessions with therapy dog present

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.

Sponsors

Purina Petcare
CollaboratorUNKNOWN
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in AnxietyBaseline 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 DepressionBaseline 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 OutcomesBaseline 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 motivationBaseline 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 recoveryBaseline 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026