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

Primary Purpose

Stroke, Parkinson's Disease, Muscle Weakness

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Canine Animal-Assisted Therapy
Standard of Care Physical Therapy
Sponsored by
Aurora Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Physical Therapy Modalities, Motivation, Patient Participation, Animal Assisted Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aurora Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-AAT Group

AAT Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change Ball Throwing Distance
The change in the distance a tennis ball is thrown (averaged over three throws) between daily trials.
Change in Standing Time
The change in the amount of time the patient spends standing per session over time.
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.
Change in Walking Capacity
The change in distance or amount of time patients spend walking between daily trials.
Change in Sitting Count
The change in the number of times the patient sits (stops standing) between daily trials.
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.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2015
Last Updated
December 27, 2016
Sponsor
Aurora Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT02606006
Brief Title
Inpatient Physical Activity Function Through Enhanced Participation Levels in Animal-Assisted Therapy Programs
Official Title
Inpatient Physical Activity Function Through Enhanced Participation Levels in Animal-Assisted Therapy Programs
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Removing from ClinicalTrials.gov as this is not really a clinical trial.
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurora Health Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Many medical care facilities in the United States employ therapy dogs in Animal Assisted Interventions (AAI), which can be categorized as either Animal Assisted Activities (AAA) or Animal Assisted Therapy (AAT). AAA programs are more casual and are typically not goal-oriented, instead tending to focus on human-animal engagement. AAT programs are formal interventions targeting specific therapeutic goals using defined therapy sessions with a physical, psychological, occupational, or speech therapist. AAT programs with Physical Therapists focus on patients with motor deficits, such as those hospitalized due to stroke (14.5-16.1% lifetime incidence), Parkinson's (1.3-2% lifetime incidence), or other neurological injuries/disorders. In the last decade, the popularity of AAT programs in hospitals has significantly increased, and there has been tremendous growth in the number of studies assessing whether the use of canine AAA or AAT have positive medical impacts on patients. Currently, the majority of studies focus on AAA programs, possibly because AAT programs require formally trained therapists and animals, program consistency, and strict program structure. Unfortunately, while most studies suggest that use of AAT can improve patient outcomes, many are poorly designed, poorly described, and few include randomized, controlled trials (RCT). The few existing RCT AAT studies focus on depression, schizophrenia, or other psychiatric disorders and suggest improvements in depression, anxiety, self-esteem, social outcomes, and enjoyment/pleasure. No RCT studies have looked at AAT in a physical therapy setting. However, non-controlled, non-randomized studies suggest that AAT as part of physical therapy may improve patient physical outcomes (such as walking speed, number of steps, gait, etc.), possibly by impacting patient motivation and participation in physical therapy activities. The Aurora Sinai Medical Center (ASMC) currently utilizes both AAA and AAT programs. Most patients involved in the AAT program at ASMC are undergoing intensive inpatient physical therapy due to stroke, Parkinson's disease, or other diseases causing generalized weakness deconditioning, and these inpatients receive daily physical therapy with the occasional opportunity to include AAT in their therapy sessions. Previous studies suggest that patient interactions with therapy dogs are intrinsically rewarding, suggesting that use of an AAT program may increase patient motivation to participate and thus improve physical indices. However, this has yet to be objectively analyzed. Hypothesis: Canine AAT in inpatient physical therapy improves physical activity function through enhanced levels of participation in physical therapy sessions. Specific Aim 1: To evaluate whether patient participation increases during physical therapy using canine AAT. Physical activity function is impacted by a patient's level of participation, which is influenced by multiple sub-factors. Participation can be measured in multiple ways, including subjectively by the patient, subjectively by an observer (the physical therapist), or objectively through activity outputs. The level of participation may or may not correlate with the patient's self-perceived motivation. Specific Aim 2. To determine whether use of canine AAT increases patient enjoyment and motivation in physical therapy. Many people perceive interactions with animals as intrinsically motivating and enjoyable. Consistent with this, canine AAT can improve patient motivation to participate in physical therapy. However, neither enjoyment nor motivation have been studied in physical therapy rehabilitation inpatients, nor have they been tested in RCT settings. Specific Aim 3: To assess whether patient perceptions of care improve with use of canine AAT in physical therapy. Because the presence of a therapy canine may improve mood, motivation, and/or patient/caregiver communications, we hypothesize that use of canine AAT in inpatient physical therapy will improve patient perceptions of their caregivers, their care, and the hospital. Innovation and Impact While AAT programs are currently used throughout the United States in inpatient rehabilitation programs, it is unknown whether and how these programs impact patient physical activity functions. This study will elucidate whether these programs provide benefits to patients or medical institutions, thereby providing medical providers with the data necessary to choose the most effective and impactful care for their patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Parkinson's Disease, Muscle Weakness
Keywords
Physical Therapy Modalities, Motivation, Patient Participation, Animal Assisted Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-AAT Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
AAT Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Canine Animal-Assisted Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Physical Therapy
Intervention Description
This intervention is the standard of care physical therapy currently offered. No canine is present.
Primary Outcome Measure Information:
Title
Change Ball Throwing Distance
Description
The change in the distance a tennis ball is thrown (averaged over three throws) between daily trials.
Time Frame
The change in ball throwing distance will be measured every day over 3-5 days.
Title
Change in Standing Time
Description
The change in the amount of time the patient spends standing per session over time.
Time Frame
During every therapy session over 3-5 days.
Title
Change in Patient Engagement/Motivation Levels
Description
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.
Time Frame
Between every therapy session over 3-5 days.
Title
Change in Walking Capacity
Description
The change in distance or amount of time patients spend walking between daily trials.
Time Frame
Between every therapy session over 3-5 days.
Title
Change in Sitting Count
Description
The change in the number of times the patient sits (stops standing) between daily trials.
Time Frame
Between every therapy session over 3-5 days.
Title
Change in Patient Visual Cues of Emotion
Description
The change in the number of times the patient demonstrates visual cues for different emotions between daily trials.
Time Frame
Between every therapy session over 3-5 days.
Other Pre-specified Outcome Measures:
Title
Perceptions of Care
Description
Patient perceptions of the quality of care they have received from the medical center and physical therapy staff will be assessed through a questionnaire.
Time Frame
On the last day of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mindy Waite, PhD
Organizational Affiliation
Aurora Health Care - Aurora Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora Sinai Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Inpatient Physical Activity Function Through Enhanced Participation Levels in Animal-Assisted Therapy Programs

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