Trial Outcomes & Findings for Effects of Animal-assisted Therapy on Brain-injured Patients (NCT NCT02599766)

NCT ID: NCT02599766

Last Updated: 2019-07-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2019-07-01

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	22
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Animal-assisted Therapy on Brain-injured Patients

Baseline characteristics by cohort

Measure	AAT and Control Intervention n=19 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	50.84 years STANDARD_DEVIATION 14.40 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Switzerland	19 Participants n=5 Participants
FIM (Functional Independence Measure)	68.67 units on a scale STANDARD_DEVIATION 26.08 • n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Social Functioning: Total Social Behavior	29.22 percentage of shown behavior Standard Deviation 15.66	8.68 percentage of shown behavior Standard Deviation 8.85

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Social Functioning: Verbal Communication	25.4 percentage of verbal communication Standard Deviation 19.44	19.04 percentage of verbal communication Standard Deviation 20.24

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Social Functioning: Nonverbal Communication	31.94 percentage of nonverbal communication Standard Deviation 17.54	5.26 percentage of nonverbal communication Standard Deviation 7.09

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Social Functioning: Physical Contact	18.32 percentage of physical contact Standard Deviation 18.50	1.53 percentage of physical contact Standard Deviation 9.70

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Social Functioning: Attention	89.01 percentage of attention Standard Error 2.01	90.65 percentage of attention Standard Error 2.00

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Positive Emotional Display	6.95 percentage of positive emotion Standard Deviation 7.47	3.75 percentage of positive emotion Standard Deviation 4.57

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Negative Emotional Display	0.31 percentage of negative emotion Standard Deviation 1.34	0.59 percentage of negative emotion Standard Deviation 2.05

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Neutral Emotional Display	92.73 percentage of neutral emotion Standard Deviation 7.64	94.20 percentage of neutral emotion Standard Deviation 6.60

SECONDARY outcome

Timeframe: 6 weeks

Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Mood 1: Motivation	138.80 units on a scale Standard Deviation 27.13	132.22 units on a scale Standard Deviation 28.21

SECONDARY outcome

Timeframe: 6 weeks

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).

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Mood 2: Bipolar Mood Dimension (Good-bad)	16.93 units on a scale Standard Deviation 4.20	16.12 units on a scale Standard Deviation 4.29

SECONDARY outcome

Timeframe: 6 weeks

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).

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Mood 3: Satisfaction Self-assessment	129.81 units on a scale Standard Deviation 23.80	124.54 units on a scale Standard Deviation 37.81

SECONDARY outcome

Timeframe: 6 weeks

Satisfaction during the therapy sessions was assessed by the therapist using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Mood 4: Satisfaction Therapist Rating	137.31 units on a scale Standard Deviation 23.80	128.14 units on a scale Standard Deviation 27.75

SECONDARY outcome

Timeframe: 6 weeks

Assessed via EKG (Polar) during the sessions and measured in beat/min.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Heart Rate	85.23 beats per minute Standard Deviation 13.03	83.41 beats per minute Standard Deviation 14.86

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Animal Assisted Therapy n=19 Participants "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	Standard Therapy n=19 Participants "Standard therapy" without the presence of an animal. standard therapy: standard physiotherapy, standard speech therapy and standard occupational therapy
Motor Activity	90.93 counts per minute Standard Deviation 55.45	75.88 counts per minute Standard Deviation 60.67

Adverse Events

Animal Assisted Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Karin Hediger

Swiss TPH

Phone: 0041795197885

Email: karin.hediger@unibas.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place