Huma-Animal Interaction to Promote Recovery Following Pediatric Brain Injury

Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Source Children's Hospital Medical Center, Cincinnati
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.

Overall Status Not yet recruiting
Start Date July 1, 2019
Completion Date July 31, 2020
Primary Completion Date July 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Patient Participation - AAT Throughout study completion, an average of 2 weeks
Patient Participation - TAU Throughout study completion, an average of 2 weeks
Objective session participation - AAT Throughout study completion, an average of 2 weeks
Objective session participation - TAU Throughout study completion, an average of 2 weeks
Patient Affect - AAT Throughout study completion, an average of 2 weeks
Patient Affect - TAU Throughout study completion, an average of 2 weeks
Objective mood assessment - AAT Throughout study completion, an average of 2 weeks
Objective mood assessment - TAU Throughout study completion, an average of 2 weeks
Secondary Outcome
Measure Time Frame
Heart rate- AAT Throughout study completion, an average of 2 weeks
Temperature - AAT Throughout study completion, an average of 2 weeks
Galvanic Skin Response - AAT Throughout study completion, an average of 2 weeks
Heart Rate - Tau Throughout study completion, an average of 2 weeks
Temperature - Tau Throughout study completion, an average of 2 weeks
Galvanic skin response - Tau Throughout study completion, an average of 2 weeks
Enrollment 40
Condition
Intervention

Intervention type: Other

Intervention name: AAT - Dog

Description: therapy dog added to inpatient PT and OT session

Arm group label: Animal Assisted Therapy - Dog Session

Intervention type: Other

Intervention name: TAU - No Dog

Description: PT and OT as usual without the addition of therapy dog

Arm group label: Treatment as usual - No Dog session

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.

Gender: All

Minimum age: 6 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Megan Narad, PhD Principal Investigator Children's Hospital Medical Center, Cincinnati
Overall Contact

Last name: Megan Narad, PhD

Phone: 513-803-8902

Email: [email protected]

Location
facility contact
Cincinnati Children's Hospital Medical Center Megan Narad, PhD 513-803-8902 [email protected]
Location Countries

United States

Verification Date

July 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Animal Assisted Therapy - Dog Session

Arm group type: Experimental

Description: Therapy dog added to PT and OT session

Arm group label: Treatment as usual - No Dog session

Arm group type: Active Comparator

Description: No dog added to PT and OT session - PT and OT session as usual standard of care

Acronym AAT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov