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Animal Assisted Therapy for Traumatic Brain Injury

N/A

Recruiting

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis: Participants must be admitted to the inpatient rehabilitation unit for treatment of an acquired brain injury (TBI, brain tumor, infection, etc.)

Age at the time of screening: 4-21 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study completion - an average of 2 weeks

Awards & highlights

Study Summary

This trial will study whether involving dogs in physical and occupational therapies while receiving inpatient rehabilitation improves patient engagement following acquired brain injury (ABI).

Who is the study for?

This trial is for children and adolescents aged 4-21 who are in inpatient rehab after a brain injury like TBI or infection. They must be responsive (Rancho score >2), have consent from guardians, and assent to participate. It's not for those with communicable diseases, immune issues, dog allergies/fears, history of animal abuse, or developmental delays before the injury.Check my eligibility

What is being tested?

The study tests if including dogs in physical and occupational therapy sessions improves engagement during rehabilitation for pediatric brain injuries. It uses a crossover design where each patient experiences both standard care and animal-assisted therapy to see which works better.See study design

What are the potential side effects?

Since this trial involves animal-assisted therapy rather than medication, traditional side effects aren't expected. However, there might be risks related to interactions with animals such as stress or discomfort if the child has underlying fears or allergies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am admitted for rehab due to a brain injury like TBI, tumor, or infection.

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I am between 4 and 21 years old.

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I am either male or female.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study completion - an average of 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study completion - an average of 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study completion - an average of 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Engagement rating.

Patient Participation/engagement

Secondary outcome measures

Automated mood assessment

Objective mood assessment

Patient-reported mood

+2 more

Other outcome measures

Anthropomorphism

Patient-animal rapport

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

animal assisted therapy

Group II: ControlActive Control1 Intervention

Treatment as usual

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,506 Total Patients Enrolled

Miami UniversityOTHER

13 Previous Clinical Trials

2,576 Total Patients Enrolled

Ohio State UniversityOTHER

829 Previous Clinical Trials

505,653 Total Patients Enrolled

Media Library

Animal Assisted Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05250180 — N/A

Traumatic Brain Injury Research Study Groups: Intervention, Control

Traumatic Brain Injury Clinical Trial 2023: Animal Assisted Therapy Highlights & Side Effects. Trial Name: NCT05250180 — N/A

Animal Assisted Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05250180 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are more participants being taken on for this experiment?

"According to clinicaltrials.gov, this particular trial has ceased its recruitment efforts since the most recent edit on July 28th 2022. However, there are 899 other medical studies presently enrolling patients at present."

Answered by AI

Does this research embrace elderly people beyond the age of eighty-five?

"The prerequisites for this research necessitate that participants must be between 4 and 21 years old. There are 156 studies available to people younger than 18, while 700 studies have been developed for those above 65."

Answered by AI

Could I qualify to join this research procedure?

"This clinical trial seeks 90 participants between the ages of four and 21 who have suffered an acquired brain injury, such as a traumatic brain injury (TBI), a tumor, or infection. In order for patients to be eligible for inclusion in this study, their families must provide informed consent and the patient themselves are required to give assent. Additionally, Rancho scores need to indicate that they are sufficiently responsive at the time of enrollment."

Answered by AI

What is the core aim of this investigation?

"Over the two week trial period, investigators aim to evaluate patient engagement. Secondary endpoints of this study include automated facial analysis using Noldus FaceReader technology and saliva oxytocin tests as well as an objective assessment of mood via behavioral coding with Noldus Observer software covering six overarching constructs - Positive affect, negative affect, anxious-fearful affect, neutral affect, touch-physical contact, and persistence on task."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Animal Assisted Therapy After Pediatric Brain Injury: Mediators and Moderators of Treatment Response.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05250180.

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