Status:

RECRUITING

Animal Assisted Therapy After Pediatric Brain Injury: Mediators and Moderators of Treatment Response.

Lead Sponsor:

Children's Hospital Medical Center, Cincinnati

Collaborating Sponsors:

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

Miami University

Conditions:

Brain Injuries

Eligibility:

All Genders

4-24 years

Phase:

NA

Brief Summary

Children requiring inpatient rehabilitation treatment following acquired brain injury (ABI) are at risk for poor engagement in rehabilitative therapies. A within subject crossover design will be used ...

Eligibility Criteria

Inclusion

  • Diagnosis: Participants must be admitted to the inpatient rehabilitation unit for treatment of an acquired brain injury (TBI, brain tumor, infection, etc).
  • Consent: The family must provide informed consent by parents or legal guardians.
  • Assent: The child/adolescent must provide a signature indicating assent to participate in the study.
  • Age at the time of screening: 4-21 years old
  • Sex: includes both males and females
  • Responsiveness: Rancho score greater than 2 at the time of enrollment (as noted in the medical chart).

Exclusion

  • Allergies: Patient has a significant allergy to dogs
  • Fear: Patient has a significant fear of dogs
  • Disease: Participant is on contact precautions or has a communicable disease that may pose a risk to the dog or dog handler or has a compromised immune system where interacting with the dog and/or handler would be of significant risk to the patient.
  • Medical History: History of developmental delay prior to ABI.
  • Behavioral History: Participant or family has a history of animal abuse or cruelty.
  • Responsiveness: Rancho score of 2 or less

Key Trial Info

Start Date :

July 22 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT05250180

Start Date

July 22 2022

End Date

June 30 2026

Last Update

May 8 2025

Active Locations (1)

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1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229