Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury

NCT04016961 | Completed

• 2 other identifiers: CIN001-AAT1R21HD095132-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Acquired Brain Injury; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (8)

• Patient Participation - AAT

  Patient participation during AAT sessions will be assessed using the Pittsburgh Rehabilitation Participation Scale (PRPS)The PRPS is a 6-item Likert-type, clinician-rated measure that quantifies observed patient participation in their therapy session. Therapists report their observations regarding patient's completion of exercises, effort applied to exercises, and level of support needed to complete activities. Scores range from 1 (None) to 6 (excellent). Therapists will complete this measure at the end of each AAT session. Ratings across the 5 (on average) AAT sessions will be used to create an patient participation - AAT score.

  Throughout study completion, an average of 2 weeks

• Patient Participation - TAU

  Patient participation during TAU sessions will be assessed using the Pittsburgh Rehabilitation Participation Scale (PRPS)The PRPS is a 6-item Likert-type, clinician-rated measure that quantifies observed patient participation in their therapy session. Therapists report their observations regarding patient's completion of exercises, effort applied to exercises, and level of support needed to complete activities. Scores range from 1 (None) to 6 (excellent). Therapists will complete this measure at the end of each TAU session. Scores across the 5 (on average) TAU sessions will be used to create a single patient participation - TAU score.

  Throughout study completion, an average of 2 weeks

• Objective session participation - AAT

  Objective session participation will be assessed via videotaped sessions for at least 2 AAT sessions. Coders will provide an objective measure of participation by rating patient in session participation using the Pittsburgh Rehabilitation Participation Scale (PRPS). Coders will score participation using the PRPS and rate the participants level of participation from 1 (None) to 6 (Excellent). These coder ratings will be used to create an overall objective session participation AAT score.

  Throughout study completion, an average of 2 weeks

• Objective session participation - TAU

  Objective session participation will be assessed via videotaped sessions for at least 2 TAU sessions. Coders will provide an objective measure of participation by rating patient in session participation using the Pittsburgh Rehabilitation Participation Scale (PRPS). Coders will score participation using the PRPS and rate the participants level of participation from 1 (None) to 6 (Excellent). These coder ratings will be used to create an overall objective session participation TAU score.

  Throughout study completion, an average of 2 weeks

• Patient Affect - AAT

  Patient affect will be assessed via the Symptom Inventory Scale - Short.This measure is a 4-item measure, where the patient reports the degree (from 0-10) they are experiencing each feeling/condition presented (Happy, fatigue, distraction, irritability). The patient will be asked to complete this measure at the beginning and end of each AAT session. These ratings will be used to create happy, fatigue, distracted, and irritable - AAT scores. Greater scores are reflective of greater levels of that emotion.

  Throughout study completion, an average of 2 weeks

• Patient Affect - TAU

  Patient affect will be assessed via the Symptom Inventory Scale - Short.This measure is a 4-item measure, where the patient reports the degree (from 0-10) they are experiencing each feeling/condition presented (Happy, fatigue, distraction, irritability). The patient will be asked to complete this measure at the beginning and end of each TAU session. These ratings will be used to create happy, fatigue, distracted, and irritable - TAU scores. Greater scores are indicative of greater levels of that emotion.

  Throughout study completion, an average of 2 weeks

• Objective mood assessment - AAT

  Objective mood assessment will be completed for at least 2 AAT sessions via coding of video taped sessions. Coders naïve to hypotheses will assess the percentage of time the patient displays positive and negative affect. Greater scores. Greater scores are indicative of greater levels of positive and negative affect. Scores across all coded AAT sessions will be used to create a positive affect-AAT score and negative affect-AAT score.

  Throughout study completion, an average of 2 weeks

• Objective mood assessment - TAU

  Objective mood assessment will be completed for at least 2 TAU sessions via coding of video taped sessions. Coders naïve to hypotheses will assess the percentage of time the patient displays positive and negative affect. Greater scores. Greater scores are indicative of greater levels of positive and negative affect. Scores across all coded TAU sessions will be used to create a positive affect-TAU score and negative affect-TAU score.

  Throughout study completion, an average of 2 weeks

Secondary Outcomes (6)

• 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

Study Arms (2)

Animal Assisted Therapy - Dog Session

EXPERIMENTAL

Therapy dog added to PT and OT session

Other: AAT - Dog

Treatment as usual - No Dog session

ACTIVE COMPARATOR

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

Other: TAU - No Dog

Interventions

AAT - Dog OTHER

therapy dog added to inpatient PT and OT session

Animal Assisted Therapy - Dog Session

TAU - No Dog OTHER

PT and OT as usual without the addition of therapy dog

Treatment as usual - No Dog session

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Megan Narad, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: July 12, 2019
• Study Start: August 6, 2019
• Primary Completion: March 10, 2020
• Study Completion: July 31, 2021
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)