Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury

NCT ID: NCT04016961

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-06
• Study Completion Date: 2021-07-31

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.

Conditions

Brain Injuries; Acquired Brain Injury; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Animal Assisted Therapy - Dog Session

Therapy dog added to PT and OT session

Group Type: EXPERIMENTAL

AAT - Dog

Intervention Type: OTHER

therapy dog added to inpatient PT and OT session

Treatment as usual - No Dog session

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

Group Type: ACTIVE_COMPARATOR

TAU - No Dog

Intervention Type: OTHER

PT and OT as usual without the addition of therapy dog

Interventions

AAT - Dog

therapy dog added to inpatient PT and OT session

Intervention Type: OTHER

TAU - No Dog

PT and OT as usual without the addition of therapy dog

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan Narad, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

1R21HD095132-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CIN001-AAT

Identifier Type: -

Identifier Source: org_study_id