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Clinical Trials/NCT05046574
NCT05046574
Completed
N/A

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

Mayo Clinic1 site in 1 country52 target enrollmentFebruary 20, 2023
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Mayo Clinic
Enrollment
52
Locations
1
Primary Endpoint
Change in Anxiety
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 20, 2023
End Date
February 21, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arya B. Mohabbat, M.D.

Principal Investigator

Mayo Clinic

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.

Outcomes

Primary Outcomes

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 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 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 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.

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.

Study Sites (1)

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