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Inpatient Physical Activity Function Through Enhanced Participation Levels in Animal-Assisted Therapy Programs

This study has been withdrawn prior to enrollment.
(Removing from ClinicalTrials.gov as this is not really a clinical trial.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02606006
First Posted: November 17, 2015
Last Update Posted: December 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aurora Health Care
  Purpose
Thousands of canines are used for therapy in health care centers throughout the United States as part of a volunteer therapy team, yet little is known about the outcomes provided by these teams. Although many studies have been published, few used randomized, controlled formats to identify whether canine therapy has an impact and any mechanisms by which any impact may occur. The purpose of this study is use a randomized, controlled setup for canine animal-assisted therapy (AAT) in patients undergoing inpatient physical therapy for stroke, Parkinson's disease, or generalized weakness deconditioning to determine whether use of AAT produces desirable outcomes, such as increased motivation, in patients.

Condition Intervention
Stroke Parkinson's Disease Muscle Weakness Behavioral: Canine Animal-Assisted Therapy Behavioral: Standard of Care Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inpatient Physical Activity Function Through Enhanced Participation Levels in Animal-Assisted Therapy Programs

Resource links provided by NLM:


Further study details as provided by Aurora Health Care:

Primary Outcome Measures:
  • Change Ball Throwing Distance [ Time Frame: The change in ball throwing distance will be measured every day over 3-5 days. ]
    The change in the distance a tennis ball is thrown (averaged over three throws) between daily trials.

  • Change in Standing Time [ Time Frame: During every therapy session over 3-5 days. ]
    The change in the amount of time the patient spends standing per session over time.

  • Change in Patient Engagement/Motivation Levels [ Time Frame: Between every therapy session over 3-5 days. ]
    The change in patient engagement will be measured by the therapist's perceptions of engagement, as well as the patient's self-perceived engagement/motivation levels between daily trials through questionnaires.

  • Change in Walking Capacity [ Time Frame: Between every therapy session over 3-5 days. ]
    The change in distance or amount of time patients spend walking between daily trials.

  • Change in Sitting Count [ Time Frame: Between every therapy session over 3-5 days. ]
    The change in the number of times the patient sits (stops standing) between daily trials.

  • Change in Patient Visual Cues of Emotion [ Time Frame: Between every therapy session over 3-5 days. ]
    The change in the number of times the patient demonstrates visual cues for different emotions between daily trials.


Other Outcome Measures:
  • Perceptions of Care [ Time Frame: On the last day of the intervention ]
    Patient perceptions of the quality of care they have received from the medical center and physical therapy staff will be assessed through a questionnaire.


Enrollment: 0
Study Start Date: November 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non-AAT Group
Inpatients in this group will receive 3-5 brief afternoon physical therapy sessions over 3-5 successive days. None of the sessions will include use of a canine for AAT. This group will include the intervention of Standard of Care Physical Therapy
Behavioral: Standard of Care Physical Therapy
This intervention is the standard of care physical therapy currently offered. No canine is present.
Experimental: AAT Group
Inpatients in this group will receive 3-5 brief afternoon physical therapy sessions over 3-5 successive days. The session on the middle day will include use of a canine for AAT. This group will receive a behavioral intervention of Canine Animal-Assisted Therapy.
Behavioral: Canine Animal-Assisted Therapy
Canine Animal-Assisted Therapy is the inclusion of a certified therapy canine in the standard of care physical therapy session, such as for walking, fetching balls, standing/petting, etc.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are being rehabilitated as an inpatient for Parkinson's, stroke, or generalized weakness deconditioning (muscle weakness);
  2. Are able to give informed consent or communicate either verbally or in writing;
  3. Are able to follow instructions;
  4. Are at least 18 years old; and
  5. Choose to participate.

Exclusion Criteria:

  1. Have a fear/dislike of dogs;
  2. Show noticeable cues of resistance/discomfort to dogs;
  3. Are allergic to dogs;
  4. Are immunocompromised;
  5. Are not being rehabilitated for Parkinson's, stroke, or generalized weakness deconditioning (muscle weakness);
  6. Are not able to give informed consent or communicate either verbally or in writing;
  7. Are not able to follow instructions;
  8. Do not speak English;
  9. Are not at least 18 years old; and
  10. Do not choose to participate.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606006


Locations
United States, Wisconsin
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States, 53233
Sponsors and Collaborators
Aurora Health Care
Investigators
Principal Investigator: Mindy Waite, PhD Aurora Health Care - Aurora Research Institute
  More Information

Publications:
Therapy Dogs International: In W. M (ed), 2015.
Handbook on Animal-Assisted Therapy (2 Ed.): Academic Press, 2006.
Delta Society: What are Animal-Assisted Activities/Therapy? Retrieved June 19, 2015, from http://www.petpartners.org/document.doc?id=1102
Maujean A, Pepping CA, Kendall E: A Systematic Review of Randomized Controlled Trials of Animal-Assisted Therapy on Psychosocial Outcomes. Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2015, 28:23-36.
Nimer J, Lundahl B: Animal-Assisted Therapy: A Meta-Analysis. Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2007, 20:225-238.
Chur-Hansen A, McArthur M, Winefield H, Hanieh E, Hazel S: Animal-Assisted Interventions in Children's Hospitals: A Critical Review of the Literature. European Journal of Marketing. 2014, 27:5-18.
Marino L: Construct Validity of AnimalAssisted Therapy and Activities: How Important Is the Animal in AAT? Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2012, 25:139-151.
Marr CA, French L, Thompson D, Drum L, Greening G, Mormon J, Henderson I, Hughes CW: Animal-Assisted Therapy in Psychiatric Rehabilitation. Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2000, 13:43-47.
About TDI. Retrieved 05/11/2015, 2015 from http://www.tdi-dog.org/About.aspx
Definitions Development Task Force of the Standards Committee: American Veterinary Medical Association: Handbook for animal-assisted activities and animal-assisted therapy., Generic terms and definitions. (Vol. 48). Renton, WA: Delta Society, 1992.
Holcomb R, Meacham M: Effectiveness of an Animal-Assisted Therapy Program in an Inpatient Psychiatric Unit. ANTHROZOÖS. 1989, 2:259-264.
Villalta-Gil V, Roca M, Gonzalez N, Domènec E, Cuca, Escanilla A, Asensio MR, Esteban ME, Ochoa S, Haro JM: Dog-Assisted Therapy in the Treatment of Chronic Schizophrenia Inpatients. ANTHROZOÖS. 2009, 22:149-159
Cohen J: Statistical Power Analysis for the Behavioral Sciences. New York, NY: Routledge Academic, 1988.
Ryan RM: Control and information in the intrapersonal sphere: An extension of cognitive evaluation theory. Journal of Personality and Social Psychology. 1982, 43:450-461.
Mihelj M, Novak D, Milavec M, Ziherl J, Olenšek A, Munih M: Virtual Rehabilitation Environment Using Principles of Intrinsic Motivation and Game Design. Presence: Teleoperators and Virtual Environments. 2012, 21:1-15.
Pound P, Gompertz P, Ebrahim S: Patients' satisfaction with stroke services. Clinical Rehabilitation. 1994, 8:7-17.

Responsible Party: Aurora Health Care
ClinicalTrials.gov Identifier: NCT02606006     History of Changes
Other Study ID Numbers: 15-95
First Submitted: November 12, 2015
First Posted: November 17, 2015
Last Update Posted: December 29, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aurora Health Care:
Physical Therapy Modalities
Motivation
Patient Participation
Animal Assisted Therapy

Additional relevant MeSH terms:
Parkinson Disease
Muscle Weakness
Paresis
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms