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

NCT02606006 | Withdrawn

• 1 other identifier: 15-95
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Parkinson's Disease; Muscle Weakness

Keywords

Physical Therapy Modalities; Motivation; Patient Participation; Animal Assisted Therapy

Outcome Measures

Primary Outcomes (6)

• Change Ball Throwing Distance

  The change in the distance a tennis ball is thrown (averaged over three throws) between daily trials.

  The change in ball throwing distance will be measured every day over 3-5 days.

• Change in Standing Time

  The change in the amount of time the patient spends standing per session over time.

  During every therapy session over 3-5 days.

• Change in Patient Engagement/Motivation Levels

  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.

  Between every therapy session over 3-5 days.

• Change in Walking Capacity

  The change in distance or amount of time patients spend walking between daily trials.

  Between every therapy session over 3-5 days.

• Change in Sitting Count

  The change in the number of times the patient sits (stops standing) between daily trials.

  Between every therapy session over 3-5 days.

• Change in Patient Visual Cues of Emotion

  The change in the number of times the patient demonstrates visual cues for different emotions between daily trials.

  Between every therapy session over 3-5 days.

Other Outcomes (1)

• Perceptions of Care

  On the last day of the intervention

Study Arms (2)

Non-AAT Group

ACTIVE COMPARATOR

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

AAT Group

EXPERIMENTAL

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

Interventions

Canine Animal-Assisted Therapy BEHAVIORAL

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.

AAT Group

Standard of Care Physical Therapy BEHAVIORAL

This intervention is the standard of care physical therapy currently offered. No canine is present.

Non-AAT Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Have a fear/dislike of dogs;
• Show noticeable cues of resistance/discomfort to dogs;
• Are allergic to dogs;
• Are immunocompromised;
• Are not being rehabilitated for Parkinson's, stroke, or generalized weakness deconditioning (muscle weakness);
• Are not able to give informed consent or communicate either verbally or in writing;
• Are not able to follow instructions;
• Do not speak English;
• Are not at least 18 years old; and
• Do not choose to participate.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

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MeSH Terms

Conditions

Stroke; Parkinson Disease; Muscle Weakness; Patient Participation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mindy Waite, PhD

  Aurora Health Care - Aurora Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 17, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 2, 2024

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)