Effects of Animal-assisted Therapy on Brain-injured Patients

Study Overview
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Brief Summary
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The purpose is to investigate whether animal-assisted therapy has positive biopsychosocial effects on patients with brain injuries. This study investigates the short-term biopsychosocial effects that occur when animals are present during therapy sessions in comparison to therapy sessions without animals, observing a group of 25 patients over 24 therapy sessions. While half of the sessions are held in presence of an animal and half without, they are as comparable as possible with respect to content and setting. In this study, patients who are in a slightly advanced rehabilitation process, assessed via their function profile, are investigated.

Detailed Description
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This study is designed as a controlled cross-over, within-subject trial with repeated measurement. The experimental condition is the standardised therapy session using therapy animals (AAT), while the control condition is the comparable standard therapy session without the presence of an animal. Over a period of six weeks, patients have four standardised therapy sessions per week, that alternate in a way that two sessions in two consecutive weeks are similar except for one is with the presence of animals and one without. In this way, data is collected over 24 therapy sessions (12 experimental, 12 control) for each patient. Each therapy session lasts 30 minutes with an additional 5 minutes before and 10 minutes after the session for filling in the questionnaires. The study takes place at REHAB Basel. Animal-assisted therapies will be held at the Therapie-Tiergarten at REHAB Basel in the presence of one or more animals that will be selected by the therapist and the patient together and with which the patient has a relationship. Patients who are willing to join the study will be selected and allocated randomly to start with either the experimental or the control condition. Participation in the study will be cancelled if a patient wishes to do so or if they choose to withdraw from the animal-assisted therapy program. Other criteria for withdrawal are if the patient is harmed by an animal or if the animals are abused by the patient.

Official Title
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Short-term Effects of Animal-assisted Therapy on the Rehabilitation Process of Brain-injured Patients at REHAB Basel

Conditions
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Impaired Social Functioning

Intervention / Treatment
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* Other: animal assisted therapy
* Other: standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient at REHAB Basel brain-injury willing to participate in animal-assisted therapies physical and psychological resilience and ability to go/be transported outside to the Therapie-Tiergarten ability to get in contact with the animal autonomously Exclusion Criteria: medical contraindications:allergies, phobias, etc. no willingness to participate in animal-assisted therapies patient might present a danger to the animals (aggressive behaviour) patient's medication changes radically during the time of data collection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: animal assisted therapy<br>Standard therapy that is done in the presence and with integrating an animal. | Other: animal assisted therapy<br>* physiotherapy, speech therapy and occupational therapy in the presence of an animal<br>|
| Active Comparator: standard therapy<br>Standard therapy without the presence of an animal. | Other: standard therapy<br>* standard physiotherapy, standard speech therapy and standard occupational therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Functioning: Total Social Behavior | Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of all social behaviors are collected and aggregated to one measure, the total social behavior. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Functioning: Verbal Communication | Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentages of the defined verbal behaviors is collected and aggregated to one measure. | 6 weeks | 
| Social Functioning: Nonverbal Communication | Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined nonverbal behaviors is collected and aggregated to one measure. | 6 weeks | 
| Social Functioning: Physical Contact | Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined physical contact is collected and aggregated to one measure. | 6 weeks | 
| Social Functioning: Attention | Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined attention behavior is collected and aggregated to one measure. | 6 weeks | 
| Positive Emotional Display | Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of positive emotion. | 6 weeks | 
| Negative Emotional Display | Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of negative emotion. | 6 weeks | 
| Neutral Emotional Display | Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of neutral emotion. | 6 weeks | 
| Mood 1: Motivation | Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated) | 6 weeks | 
| Mood 2: Bipolar Mood Dimension (Good-bad) | Assessed via the Mehrdimensionaler Befindlichkeitsfragebogen (MDBF) We analysed the bipolar mood dimension (good-bad) ranging from 4 (not at all good mood) to 20 (very good mood). | 6 weeks | 
| Mood 3: Satisfaction Self-assessment | Assessed via visual analogue scale as rating by the therapist Satisfaction during the therapy sessions was assessed by the patient themselves using a VAS ranging from 0 (unsatisfied) to 160 (satisfied). | 6 weeks | 
| Mood 4: Satisfaction Therapist Rating | Satisfaction during the therapy sessions was assessed by the therapist using a VAS ranging from 0 (unsatisfied) to 160 (satisfied). | 6 weeks | 
| Heart Rate | Assessed via EKG (Polar) during the sessions and measured in beat/min. | 6 weeks | 
| Motor Activity | Assessed via actimeter at the patients wrist during sessions, measuring acceleration of the hand. It records data in 15-s epochs for maximum sensitivity. Data were calculated to yield average activity Counts per minute. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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animal assisted intervention, brain injury, rehabilitation