CompletedNot Applicable

Human-Animal Interaction to Promote Recovery Following Pediatric Brain Injury

United States4 participantsStarted 2019-08-06

Plain-language 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.

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Participation - AAT

Timeframe: Throughout study completion, an average of 2 weeks

Patient Participation - TAU

Timeframe: Throughout study completion, an average of 2 weeks

Objective session participation - AAT

Timeframe: Throughout study completion, an average of 2 weeks

Objective session participation - TAU

Timeframe: Throughout study completion, an average of 2 weeks

Patient Affect - AAT

Timeframe: Throughout study completion, an average of 2 weeks

Patient Affect - TAU

Timeframe: Throughout study completion, an average of 2 weeks

Objective mood assessment - AAT

Timeframe: Throughout study completion, an average of 2 weeks

Trial details

NCT IDNCT04016961

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-10

View on ClinicalTrials.gov More Brain Injuries trials

Who can participate

Age range

6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient Participation - AAT

Timeframe: Throughout study completion, an average of 2 weeks

Patient Participation - TAU

Timeframe: Throughout study completion, an average of 2 weeks

Objective session participation - AAT

Timeframe: Throughout study completion, an average of 2 weeks

Objective session participation - TAU

Timeframe: Throughout study completion, an average of 2 weeks

Patient Affect - AAT

Timeframe: Throughout study completion, an average of 2 weeks

Patient Affect - TAU

Timeframe: Throughout study completion, an average of 2 weeks

Objective mood assessment - AAT

Timeframe: Throughout study completion, an average of 2 weeks