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Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury (AAT)

Primary Purpose

Brain Injuries, Acquired Brain Injury, Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AAT - Dog
TAU - No Dog
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Animal Assisted Therapy - Dog Session

Treatment as usual - No Dog session

Arm Description

Therapy dog added to PT and OT session

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Heart rate- AAT
Heart rate will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as heart rate - AAT,
Temperature - AAT
Temperature will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as temperature-AAT.
Galvanic Skin Response - AAT
Galvanic skin response (GSR) will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as GSR-AAT.
Heart Rate - Tau
Heart rate will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as heart rate - TAU.
Temperature - Tau
Temperature, and galvanic skin response will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as temperature-TAU.
Galvanic skin response - Tau
Galvanic skin response (GSR) will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as GSR-TAU.

Full Information

First Posted
May 3, 2019
Last Updated
July 9, 2019
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04016961
Brief Title
Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury
Acronym
AAT
Official Title
Huma-Animal Interaction to Promote Recovery Following Pediatric Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Acquired Brain Injury, Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Animal Assisted Therapy - Dog Session
Arm Type
Experimental
Arm Description
Therapy dog added to PT and OT session
Arm Title
Treatment as usual - No Dog session
Arm Type
Active Comparator
Arm Description
No dog added to PT and OT session - PT and OT session as usual standard of care
Intervention Type
Other
Intervention Name(s)
AAT - Dog
Intervention Description
therapy dog added to inpatient PT and OT session
Intervention Type
Other
Intervention Name(s)
TAU - No Dog
Intervention Description
PT and OT as usual without the addition of therapy dog
Primary Outcome Measure Information:
Title
Patient Participation - AAT
Description
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.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Patient Participation - TAU
Description
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.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Objective session participation - AAT
Description
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.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Objective session participation - TAU
Description
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.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Patient Affect - AAT
Description
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.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Patient Affect - TAU
Description
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.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Objective mood assessment - AAT
Description
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.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Objective mood assessment - TAU
Description
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.
Time Frame
Throughout study completion, an average of 2 weeks
Secondary Outcome Measure Information:
Title
Heart rate- AAT
Description
Heart rate will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as heart rate - AAT,
Time Frame
Throughout study completion, an average of 2 weeks
Title
Temperature - AAT
Description
Temperature will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as temperature-AAT.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Galvanic Skin Response - AAT
Description
Galvanic skin response (GSR) will be collected using an Empatica E4 wristband during each of the AAT sessions. The patient will wear the wrist band during all sessions, and data collected during AAT sessions will be summarized as GSR-AAT.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Heart Rate - Tau
Description
Heart rate will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as heart rate - TAU.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Temperature - Tau
Description
Temperature, and galvanic skin response will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as temperature-TAU.
Time Frame
Throughout study completion, an average of 2 weeks
Title
Galvanic skin response - Tau
Description
Galvanic skin response (GSR) will be collected using an Empatica E4 wristband during each of the TAU sessions. The patient will wear the wrist band during all sessions, and data collected during TAU sessions will be summarized as GSR-TAU.
Time Frame
Throughout study completion, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Narad, PhD
Phone
513-803-8902
Email
megan.narad@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Narad, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Narad, PhD
Phone
513-803-8902
Email
megan.narad@cchmc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury

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