Recruiting

Animal Assisted Therapy

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05250180

Conditions

Brain Injuries

Eligibility Criteria

Sex: All

Age: 4 - 24

Healthy Volunteers: Not accepted

Interventions

Animal Assisted Therapy

Control

Study Details

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 to determine whether involving dogs in physical and occupational therapies while receiving inpatient rehabilitation improves patient engagement, how involving dogs improves engagement, and identify who is most likely to benefit. This project addresses the critical need to establish an evidence base for animal-assisted therapies in pediatric rehabilitation, incorporates innovative methods, and has the potential to lead to improved clinical care for children and adolescents receiving intensive rehabilitation following ABI.

Conditions

Brain Injuries

Study ID

NCT05250180

Start date

Jul 22, 2022

Status verified date

May, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

animal assisted therapy

active comparator: Control

Treatment as usual

Interventions

Animal Assisted Therapy

Patients enrolled in the study will be randomly scheduled to have a dog be a part of their PT and OT sessions on two days (one in the first week and one in the second week) during their stay. On these days, the therapist will lead the therapy session and integrate the dog at whatever level is appropriate based on the patient's level of functioning and therapy goals.

Control

treatment as usual as dictated by their treatment team

Primary outcome measure

  • Patient Participation/engagement [ Time Frame: throughout study completion - an average of 2 weeks ]
  • Objective Engagement rating. [ Time Frame: throughout study completion - an average of 2 weeks ]

Central Contacts and Locations

Central contacts

Megan Narad, PhD

15138038902megan.narad@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Megan Narad, PhD

513-803-8902megan.narad@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

May 8, 2025

Last verified

May, 2025

Keywords

  • Pediatric brain injury
  • Animal assisted therapy
  • inpatient rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-05-08.