Clinical trial NCT02606006: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Parkinson's Disease
Muscle Weakness
Keywords: Physical Therapy Modalities
Motivation
Patient Participation
Animal Assisted Therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change Ball Throwing Distance
timeFrame: The change in ball throwing distance will be measured every day over 3-5 days.
measure: Change in Standing Time
timeFrame: During every therapy session over 3-5 days.
measure: Change in Patient Engagement/Motivation Levels
timeFrame: Between every therapy session over 3-5 days.
measure: Change in Walking Capacity
timeFrame: Between every therapy session over 3-5 days.
measure: Change in Sitting Count
timeFrame: Between every therapy session over 3-5 days.
measure: Change in Patient Visual Cues of Emotion
timeFrame: Between every therapy session over 3-5 days.
Secondary outcomes:
Other outcomes:
measure: Perceptions of Care
timeFrame: On the last day of the intervention
Locations:
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
Study officials:
affiliation: Aurora Health Care - Aurora Research Institute
name: Mindy Waite, PhD
role: PRINCIPAL_INVESTIGATOR
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