Clinical trial NCT04016961: Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury
Official title: Huma-Animal Interaction to Promote Recovery Following Pediatric Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Acquired Brain Injury
Traumatic Brain Injury
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-07-12
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Participation - AAT
timeFrame: Throughout study completion, an average of 2 weeks
measure: Patient Participation - TAU
timeFrame: Throughout study completion, an average of 2 weeks
measure: Objective session participation - AAT
timeFrame: Throughout study completion, an average of 2 weeks
measure: Objective session participation - TAU
timeFrame: Throughout study completion, an average of 2 weeks
measure: Patient Affect - AAT
timeFrame: Throughout study completion, an average of 2 weeks
measure: Patient Affect - TAU
timeFrame: Throughout study completion, an average of 2 weeks
measure: Objective mood assessment - AAT
timeFrame: Throughout study completion, an average of 2 weeks
measure: Objective mood assessment - TAU
timeFrame: Throughout study completion, an average of 2 weeks
Secondary outcomes:
measure: Heart rate- AAT
timeFrame: Throughout study completion, an average of 2 weeks
measure: Temperature - AAT
timeFrame: Throughout study completion, an average of 2 weeks
measure: Galvanic Skin Response - AAT
timeFrame: Throughout study completion, an average of 2 weeks
measure: Heart Rate - Tau
timeFrame: Throughout study completion, an average of 2 weeks
measure: Temperature - Tau
timeFrame: Throughout study completion, an average of 2 weeks
measure: Galvanic skin response - Tau
timeFrame: Throughout study completion, an average of 2 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Megan Narad, PhD
role: PRINCIPAL_INVESTIGATOR
References: