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| Name | Class |
|---|---|
| Institute for Interdisciplinary Research on the Human-Pet Relationship | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| animal assisted therapy | Experimental | "Standard therapy" that is done in the presence and with integrating an animal. |
|
| standard therapy | Active Comparator | "Standard therapy" without the presence of an animal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| animal assisted therapy | Other | physiotherapy, speech therapy and occupational therapy in the presence of an animal |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margret Hund-Georgiadis, PD Dr. | Rehab Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| REHAB Basel | Basel | 4012 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29035068 | Derived | Gocheva V, Hund-Georgiadis M, Hediger K. Effects of animal-assisted therapy on concentration and attention span in patients with acquired brain injury: A randomized controlled trial. Neuropsychology. 2018 Jan;32(1):54-64. doi: 10.1037/neu0000398. Epub 2017 Oct 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AAT and Control Intervention | Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal. "Standard therapy" that is done in the presence and with integrating an animal. Duration of AAT: 6 weeks (12 AAT sessions) Frequency of administration: 2 sessions/week Control intervention: standard therapy (treatment as usual): physiotherapy, speech therapy and occupational therapy without an animal Duration of control therapy: 6 weeks (12 sessions) Frequency of administration: 2 sessions/week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AAT and Control Intervention | Animal assisted therapy (AAT): physiotherapy, speech therapy and occupational therapy in the presence of an animal Control intervention: standard physiotherapy, speech therapy and occupational therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of shown behavior | 6 weeks |
|
Through study completion, 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Animal Assisted Therapy | "Standard therapy" that is done in the presence and with integrating an animal. animal assisted therapy: physiotherapy, speech therapy and occupational therapy in the presence of an animal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karin Hediger | Swiss TPH | 0041795197885 | karin.hediger@unibas.ch |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D056447 | Animal Assisted Therapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| standard therapy | Other | standard physiotherapy, standard speech therapy and standard occupational therapy |
|
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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| FIM (Functional Independence Measure) | The FIM includes 18 items, each with a maximum score of 7 and a minimum score of 1. Possible scores range from 18 to 126. Each level of scoring is defined with higher scores refering to better outcomes. | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of verbal communication | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of nonverbal communication | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of physical contact | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | percentage of attention | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of positive emotion | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of negative emotion | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of neutral emotion | 6 weeks |
|
|
|
| Secondary | Mood 1: Motivation | Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated) | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | Heart Rate | Assessed via EKG (Polar) during the sessions and measured in beat/min. | Posted | Mean | Standard Deviation | beats per minute | 6 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | counts per minute | 6 weeks |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Standard Therapy | "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy | 0 | 19 | 0 | 19 | 0 | 19 |
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |