Animal Assisted Therapy for Traumatic Brain Injury

Overseen By Megan Narad, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Dog allergy, Fear of dogs, Communicable disease, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether involving dogs in physical and occupational therapies can improve engagement for kids and teens during hospital rehabilitation for brain injuries. Researchers aim to assess how the presence of dogs might boost motivation and identify who benefits most from this approach. The trial compares sessions with dogs to regular therapy sessions to evaluate outcomes. Kids and teens in a hospital rehab program for a brain injury, who are neither afraid of nor allergic to dogs, might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative therapy methods that could enhance rehabilitation experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that animal-assisted therapy is safe for children with acquired brain injury?

Research shows that Animal Assisted Therapy (AAT) is generally safe, especially when conducted by trained animals and certified handlers. Studies have found that AAT can enhance social behavior and emotional involvement in people with brain injuries. Patients who received therapy with animals reported positive experiences and outcomes. These studies report no major negative effects, suggesting that the therapy is well-tolerated. Therefore, participants in this trial can feel confident about the safety of this therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Animal Assisted Therapy for traumatic brain injury is unique because it introduces a non-traditional approach to rehabilitation by incorporating animals into the therapeutic process. Unlike standard treatments, which often focus on medications and physical therapy, this method leverages the emotional and psychological benefits of human-animal interactions. Researchers are excited about this therapy because it has the potential to enhance mood, reduce stress, and improve social engagement, which can be particularly beneficial for patients recovering from brain injuries. This novel approach could complement existing treatments, offering a more holistic recovery experience.

What evidence suggests that Animal Assisted Therapy might be an effective treatment for acquired brain injury?

Research shows that therapy involving animals, such as dogs, can aid people with brain injuries. In this trial, some participants will receive Animal Assisted Therapy, while others will receive standard treatment. One study found that patients with brain injuries improved more with therapy involving dogs compared to those without it. Other research suggests that animal-assisted therapy can enhance social skills and emotional connections in these patients. Stories from patients and therapists also indicate benefits when this therapy combines with brain exercises. Additionally, patients have provided very positive feedback about using animals in their recovery. Overall, these findings suggest that animal-assisted therapy may help children and teens with brain injuries engage better in therapy and improve their recovery. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Assent: The child/adolescent must provide a signature indicating assent to participate in the study.

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

Consent: The family must provide informed consent by parents or legal guardians.

Exclusion Criteria

Behavioral History: Participant or family has a history of animal abuse or cruelty.

You are very scared of dogs.

You have a history of delayed development before your brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inpatient rehabilitation with and without animal-assisted therapy to assess engagement and mood

2 weeks

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Animal Assisted Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

animal assisted therapy

Group II: Control Active Control 1 Intervention

Treatment as usual

Animal Assisted Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Animal-Assisted Therapy for:

• Pediatric brain injury rehabilitation
• Traumatic brain injury recovery
• Improvement in cognitive and behavioral outcomes

Approved in European Union as Animal-Assisted Therapy for:

• Rehabilitation after acquired brain injury
• Improvement in social skills and emotional well-being
• Support for individuals with complex needs

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Miami University

Collaborator

Trials

16

Recruited

3,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy (CBT) has been found effective in reducing external aggressive behaviors in individuals with acquired brain injury (ABI), based on a systematic review of seven studies, including one randomized controlled trial and five pre-post trials.

However, CBT did not significantly impact internal feelings of anger, suggesting that while it helps manage outward aggression, it may not address the underlying emotional issues, indicating a need for further research with control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for aggression among individuals with moderate to severe acquired brain injury: a systematic review and meta-analysis. Iruthayarajah, J., Alibrahim, F., Mehta, S., et al.[2019]

In a study of 24 adult survivors of traumatic brain injury (TBI), acupuncture improved cognitive function compared to a control group, although it did not significantly change sleep time.

Acupuncture was associated with a better perception of sleep quality in TBI patients, suggesting it may be a beneficial treatment option with fewer cognitive and affective side effects compared to medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for treatment of insomnia in patients with traumatic brain injury: a pilot intervention study. Zollman, FS., Larson, EB., Wasek-Throm, LK., et al.[2015]

Cognitive behavior therapy (CBT) tailored for individuals with acquired brain injury (ABI) significantly reduced emotional distress, as evidenced by improvements on the Symptom Checklist-90-Revised and the Depression Anxiety Stress Scales in a study of 20 participants.

The study demonstrated that both group and telephone formats of the adapted CBT were effective, highlighting its flexibility in delivery for individuals with chronic ABI, although no significant changes were noted in community integration or coping strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of cognitive behavior therapy in the treatment of emotional distress after acquired brain injury. Bradbury, CL., Christensen, BK., Lau, MA., et al.[2018]

Recent animal studies on blast injuries have revealed that non-cerebral-focused traumatic brain injuries (TBIs) can lead to significant and often overlooked neuropathological outcomes, similar to those observed in a human case report.

The study highlights the importance of understanding the mechanisms of injury, such as the role of the foramen magnum in funneling blast waves, which can cause additional damage beyond the initial impact, emphasizing the need for thorough diagnostic follow-up in TBI cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed-Onset Neuropathological Complications From a Foramen Magnum and Occipital Crest-Focused Traumatic Brain Injury of the Vietnam War and Other Conflicts: Part II, Research Analysis. Burkle, FM., Hadley, KS., Ridge, LL., et al.[2022]

Animal-assisted therapy (AAT) was integrated into the rehabilitation of a middle-aged female patient after spinal surgery, comprising 32% of her therapy sessions, and aimed to enhance her engagement in therapeutic activities.

While the study noted improvements in sitting tolerance and functional independence measures, it could not definitively conclude the efficacy of AAT due to simultaneous therapies, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of animal-assisted therapy in combination with physical therapy in an inpatient rehabilitation facility: A case report. Denzer-Weiler, C., Hreha, K.[2018]

The study developed a wearable system to monitor physiological parameters during canine-assisted therapy (CAT), demonstrating a high accuracy in step counting with a mean error of ≤0.6%.

This research highlights the potential health benefits for both humans and dogs during rehabilitation activities, suggesting a need for further investigation into the mutual effects of AAT on both participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mHealth in the canine assisted therapy: the design and application of a kit for the wearable monitoring during a walking session. Giansanti, D., Maccioni, G.[2022]

Animal-assisted therapy (AAT) is a collaborative approach that integrates various health disciplines to enhance human health through interactions with qualified therapy animals, particularly dogs.

In Taiwan, the development of canine AAT has been documented, highlighting its benefits and outcomes, while also addressing practical challenges and suggesting improvements for future services and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lassie's magic: animal-assisted therapy in Taiwan]. Yeh, ML.[2009]

Animal-Assisted Therapy (AAT) is recognized by therapists as a beneficial intervention for improving various aspects of functioning in participants, but there are concerns regarding its implementation.

Many therapists see potential in Robotic Animal-Assisted Therapy (RAAT) as a viable alternative or preparatory option when live animal interaction is not feasible, although most have not yet used RAAT in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic animal-assisted therapy as a complementary therapy in clinical practice: Exploring animal-assisted intervention professional perspectives. Burr, M., Buntich, J., Gonzalez, M., et al.[2023]

Electroacupuncture (EA) treatment for 60 minutes daily over three days significantly reduced neuroinflammation and neuronal damage in a rat model of traumatic brain injury (TBI), as evidenced by decreased infarction volume and apoptosis markers.

The study suggests that EA may enhance functional recovery after TBI by mitigating the inflammatory response, indicated by lower activation of microglia and astrocytes and reduced expression of the inflammatory marker TNF-α.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early electroacupuncture treatment ameliorates neuroinflammation in rats with traumatic brain injury. Tang, WC., Hsu, YC., Wang, CC., et al.[2018]

Animal-assisted therapy (AAT) has been effective in treating various psychological disorders, such as autism, depression, anxiety, and PTSD, by enhancing comfort, motivation, and self-esteem in clients.

While AAT shows promising outcomes as an adjunct to traditional psychotherapy, there is a need for more evidence-based research to solidify its efficacy and mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Animal-assisted Therapy to Enrich Psychotherapy. Amerine, JL., Hubbard, GB.[2019]

Animal Assisted Therapy (AAT) can significantly enhance rehabilitation outcomes by engaging and motivating patients, but it requires certified and trained therapy teams to ensure safety and effectiveness.

Collaboration between AAT therapists and other clinicians is essential for maximizing treatment opportunities and achieving specific rehabilitation goals, highlighting the need for standardized practices in this emerging field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaboration in Animal-Assisted Activities and Animal-Assisted Therapy. Decina, E., Evangelista, B., Harantschuk, A.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36881697/

Efficacy of Animal-Assisted Therapy in Treatment ... Patients with traumatic brain injury receiving canine-assisted therapy demonstrated significant improvement compared with a control group.

2. nature.com nature.com/articles/s41598-019-42280-0

Effects of animal-assisted therapy on social behaviour in ... Our results show that AAT increases aspects of social competence and leads to higher emotional involvement of patients with acquired brain injury.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27341368/

Effectiveness of Animal Assisted Therapy after brain injury Anecdotal evidence suggests that brain injury survivors may benefit from the combination of AAT and cognitive rehabilitation techniques.

4. research.aota.org research.aota.org/ajot/article/76/Supplement%202/7613393020/23920/Animal-Assisted-Therapy-for-Patients-With

Animal-Assisted Therapy for Patients With Disorders of ... This Systematic Review Brief presents findings from the systematic review on the effectiveness of animal-assisted therapy to improve arousal and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2212958823000824

Animal assisted therapy in neurorehabilitation inpatient ... Responses were overwhelmingly positive about the experience, practice and effects of AAT for patients with ABI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6456498/

Effects of animal-assisted therapy on social behaviour in ... Our results show that AAT increases aspects of social competence and leads to higher emotional involvement of patients with acquired brain injury.

7. researchgate.net researchgate.net/publication/304400036_Effectiveness_of_Animal_Assisted_Therapy_after_brain_injury_A_bridge_to_improved_outcomes_in_CRT

Effectiveness of Animal Assisted Therapy after brain injury This study provides a systematic review of most of the available literature on ATT and assesses that potential uses of ATT for brain injury rehabilitation.

8. withpower.com withpower.com/trial/phase-wounds-and-injuries-2-2022-47098

Animal Assisted Therapy for Traumatic Brain Injury Animal Assisted Therapy (AAT) is generally considered safe when conducted by certified teams of trained animals and handlers. It is important to ensure proper ...