Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury

Traumatic Brain Injury Clinical Trial

— AAT  

Official title:

Huma-Animal Interaction to Promote Recovery Following Pediatric Brain Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04016961
• Other study ID #: CIN001-AAT
• Secondary ID: 1R21HD095132-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2019
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Megan Narad, PhD
• Phone: 513-803-8902
• Email: megan.narad[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the addition of therapy dogs in inpatient physical and occupational therapy. Data will be collected across 10 PT and 10 OT sessions, half of which will incorporate a therapy dog.

Description:

Children with acquired brain injuries (ABI) treated on an inpatient rehabilitation unit are at significant risk for long term functional impairment, highlighting the importance of maximizing the effectiveness and utilization of inpatient rehabilitation therapies. The proposed study seeks to explore the value of animal-assisted therapy (AAT) during inpatient rehabilitation following pediatric ABI. Investigators will employ a within subjects cross-over trial; all participants will have a volunteer dog involved in 50% of their physical therapy (PT) and occupational therapy (OT) sessions over a 2-week study period. AAT will consist of integration of a dog from the hospital volunteer dog program in PT and OT sessions, while the non-AAT condition will be treatment as usual (TAU) as identified by the patients' treatment team. Information regarding patient engagement/participation in therapy, affect, and physiological variables will be collected during each session. Session notes will also be coded for additional qualitative information. Qualitative feedback from patients and families, therapists, medical teams, and dog handlers will also be collected throughout the project to examine feasibility and satisfaction with the intervention as well as potential barriers and areas for improvement. Investigators will 1) examine the effect of AAT on level of patient participation and patient affect during PT and OT sessions, 2) Explore the effect of AAT on functional outcomes using a historic cohort comparison group, and 3) explore the physiological response of patients, and examine a number of variables (injury type/severity, child sex and anthropomorphism, therapist factors, and dog handler factors) to begin to determine which patients are most likely to benefit from AAT during inpatient rehabilitation for ABI.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis: Participants must be on the inpatient rehabilitation unit for treatment of an acquired brain injury (TBI, brain tumor, infection, stroke, etc)

• Consent: The family must provide informed consent by parents or legal guardians

• Assent: The adolescent must provide a signature indicating assent to participate in the study.

• Age at time of screening: 6 years old and older with no upper limit

• Responsiveness: Rancho score greater than 2 (or equivalent) at the time of enrollment (as noted in medical chart)

Exclusion Criteria:

• Animals: Participant has a significant allergy to dogs or have a significant fear of dogs.

• Disease: Participant has a communicable disease that may pose a risk to dog or dog handler or a compromised immune system where interacting with dog and/or handler would be of significant risk to patient.

• Responsiveness: Rancho score of 2 (or equivalent) or less

• Cognitive issues: Participants with pre-injury/pre-diagnosis of developmental delay, autism, and/or patients who are non-verbal will be excluded.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• AAT - Dog
therapy dog added to inpatient PT and OT session
• TAU - No Dog
PT and OT as usual without the addition of therapy dog

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Participation - AAT	Patient participation during AAT sessions will be assessed using the Pittsburgh Rehabilitation Participation Scale (PRPS)The PRPS is a 6-item Likert-type, clinician-rated measure that quantifies observed patient participation in their therapy session. Therapists report their observations regarding patient's completion of exercises, effort applied to exercises, and level of support needed to complete activities. Scores range from 1 (None) to 6 (excellent). Therapists will complete this measure at the end of each AAT session. Ratings across the 5 (on average) AAT sessions will be used to create an patient participation - AAT score.	Throughout study completion, an average of 2 weeks
Primary	Patient Participation - TAU	Patient participation during TAU sessions will be assessed using the Pittsburgh Rehabilitation Participation Scale (PRPS)The PRPS is a 6-item Likert-type, clinician-rated measure that quantifies observed patient participation in their therapy session. Therapists report their observations regarding patient's completion of exercises, effort applied to exercises, and level of support needed to complete activities. Scores range from 1 (None) to 6 (excellent). Therapists will complete this measure at the end of each TAU session. Scores across the 5 (on average) TAU sessions will be used to create a single patient participation - TAU score.	Throughout study completion, an average of 2 weeks
Primary	Objective session participation - AAT	Objective session participation will be assessed via videotaped sessions for at least 2 AAT sessions. Coders will provide an objective measure of participation by rating patient in session participation using the Pittsburgh Rehabilitation Participation Scale (PRPS). Coders will score participation using the PRPS and rate the participants level of participation from 1 (None) to 6 (Excellent). These coder ratings will be used to create an overall objective session participation AAT score.	Throughout study completion, an average of 2 weeks
Primary	Objective session participation - TAU	Objective session participation will be assessed via videotaped sessions for at least 2 TAU sessions. Coders will provide an objective measure of participation by rating patient in session participation using the Pittsburgh Rehabilitation Participation Scale (PRPS). Coders will score participation using the PRPS and rate the participants level of participation from 1 (None) to 6 (Excellent). These coder ratings will be used to create an overall objective session participation TAU score.	Throughout study completion, an average of 2 weeks
Primary	Patient Affect - AAT	Patient affect will be assessed via the Symptom Inventory Scale - Short.This measure is a 4-item measure, where the patient reports the degree (from 0-10) they are experiencing each feeling/condition presented (Happy, fatigue, distraction, irritability). The patient will be asked to complete this measure at the beginning and end of each AAT session. These ratings will be used to create happy, fatigue, distracted, and irritable - AAT scores. Greater scores are reflective of greater levels of that emotion.	Throughout study completion, an average of 2 weeks
Primary	Patient Affect - TAU	Patient affect will be assessed via the Symptom Inventory Scale - Short.This measure is a 4-item measure, where the patient reports the degree (from 0-10) they are experiencing each feeling/condition presented (Happy, fatigue, distraction, irritability). The patient will be asked to complete this measure at the beginning and end of each TAU session. These ratings will be used to create happy, fatigue, distracted, and irritable - TAU scores. Greater scores are indicative of greater levels of that emotion.	Throughout study completion, an average of 2 weeks
Primary	Objective mood assessment - AAT	Objective mood assessment will be completed for at least 2 AAT sessions via coding of video taped sessions. Coders naïve to hypotheses will assess the percentage of time the patient displays positive and negative affect. Greater scores. Greater scores are indicative of greater levels of positive and negative affect. Scores across all coded AAT sessions will be used to create a positive affect-AAT score and negative affect-AAT score.	Throughout study completion, an average of 2 weeks
Primary	Objective mood assessment - TAU	Objective mood assessment will be completed for at least 2 TAU sessions via coding of video taped sessions. Coders naïve to hypotheses will assess the percentage of time the patient displays positive and negative affect. Greater scores. Greater scores are indicative of greater levels of positive and negative affect. Scores across all coded TAU sessions will be used to create a positive affect-TAU score and negative affect-TAU score.	Throughout study completion, an average of 2 weeks
Secondary	Heart rate- AAT	Heart rate will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as heart rate - AAT,	Throughout study completion, an average of 2 weeks
Secondary	Temperature - AAT	Temperature will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as temperature-AAT.	Throughout study completion, an average of 2 weeks
Secondary	Galvanic Skin Response - AAT	Galvanic skin response (GSR) will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as GSR-AAT.	Throughout study completion, an average of 2 weeks
Secondary	Heart Rate - Tau	Heart rate will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as heart rate - TAU.	Throughout study completion, an average of 2 weeks
Secondary	Temperature - Tau	Temperature, and galvanic skin response will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as temperature-TAU.	Throughout study completion, an average of 2 weeks
Secondary	Galvanic skin response - Tau	Galvanic skin response (GSR) will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as GSR-TAU.	Throughout study completion, an average of 2 weeks