A Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation

NCT05046574 | Completed

• 1 other identifier: 21-005175
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Baseline through inpatient stay, an average of 2 weeks.

Study Arms (2)

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.

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.

Interventions

Stroke rehabilitative therapy sessions with therapy dog present OTHER

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.

Therapy dog during stroke rehabilitative therapy sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Purina Petcare: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arya Mohabbat, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: February 20, 2023
• Primary Completion: February 21, 2024
• Study Completion: February 21, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)