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Completed

NCT Number: NCT05046574

A Study to Evaluate Animal-assisted Therapy in Stroke Rehabilitation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Purina Petcare

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2021
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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