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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02606006
• Other study ID #: 15-95
• Status: Withdrawn
• Phase: N/A
• First received: November 12, 2015
• Last updated: December 27, 2016
• Start date: November 2015
• Est. completion date: March 2018

Study information

• Verified date: December 2016
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Parkinson Disease
• Parkinson's Disease
• Stroke

Intervention

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.
• Standard of Care Physical Therapy
This intervention is the standard of care physical therapy currently offered. No canine is present.

Locations

Country	Name	City	State
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

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* Note: There are 49 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceptions of Care	Patient perceptions of the quality of care they have received from the medical center and physical therapy staff will be assessed through a questionnaire.	On the last day of the intervention	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No