Clinical trial NCT05275543: Robot Rehab: AAI With Robot During Inpatient Pediatric Rehab
Official title: Robot Rehab: Animal Assisted Interactions With a Robotic Baby Harp Seal During Inpatient Pediatric Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Child, Hospitalized
Physical Therapy Modalities
Occupational Therapy
Animal Assisted Therapy
Keywords: Robot
Animal Assisted Interaction
Hosptilization
Rehabiliation
Pediatric
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with Repeated Measures
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to:

Aim 1: Evaluate the feasibility \[consent and refusal rates, attrition rates, length, and number of completed therapy sessions\], and acceptability \[interviews with children and guardians, overall patient and guardian satisfaction\] during inpatient physical therapy (PT) and occupational therapy (OT) sessions. Hypothesis: Animal-assisted interaction (AAI) with Paro, a robotic baby harp seal, during pediatric inpatient PT/OT sessions will be feasible and acceptable.

Aim 2: Assess preliminary efficacy of AAI during PT/OT sessions with Paro on behavior (anxiety and affect) and motivation to participate in rehabilitation in hospitalized children. Hypothesis: Children who use Paro will demonstrate less anxiety, more positive affect, and greater motivation to participate in therapy than those who do not use Paro.

Aim 3: Test the stress, anxiety, and depression levels of parents/guardians of children who use Paro inpatient physical and occupational therapy sessions. Hypothesis: In addition, parents and guardians of children that use Paro will report less stress, anxiety, and depression compared to parents/guardians of children that do not use Paro.

Detailed description: Animal Assisted Interactions (AAIs) are interventions that intentionally incorporate animals as part of a therapeutic process to promote human health, learning, and well-being. In general, domestic and farm animals such as dogs, cats, birds, equines, guinea pigs, rabbits, llamas, sheep, goats, and pigs are predominantly featured in AAI programs. Animals can be observed, held, and petted, or more actively integrated into specific therapy activities such as brushing with different tools to encourage range of motion and fine motor coordination. AAIs also promote exercise through tandem walking with the animals. Recent literature indicates that AAI can improve reality orientation and attention span, eliminate the sense of isolation, reduce stress and anxiety, enhance communication, promote positive social interactions, and enhance overall quality of life. The use of AAI in hospitalized children has the potential to engage patients, family members, and healthcare staff in an innovative, holistic approach to recovery.

While additional research is warranted to further explore the potential impact of AAI on a variety of clinically meaningful patient outcomes, the highly technical, fast-paced hospital environment and the immunocompromised health statuses of many acutely ill hospitalized patients greatly limit the exploration of AAI in inpatient settings. A new frontier in animal robotics opens a vast array of opportunities to implement AAI in hospitalized populations. Robot animals may be just as effective as live animals and may provide even more flexibility and tailoring to meet the needs of diverse situations that arise in the hospital. In addition, the infection control risk that live animals pose to hospitalized patients may be significantly lessened.

For this study, the investigators plan to conduct a two-armed randomized controlled trial with repeated measures. Hospitalized pediatric patients will participate in semi-structured, prescriptive physical and occupational therapy sessions on the categories of: 1) speech; 2) balance and endurance; 3) memory; 4) self-esteem; 5) fine motor; 6) sensory stimulation. Intervention group subjects (n=30) will participate in 10-30 minute therapy sessions with Paro, a therapeutic robotic baby harp seal. Control group subjects (n=30) will participate in 10-30 minute therapy sessions without Paro.

Eligibility criteria: Inclusion Criteria:

* Age 5-18
* admitted to any of the five inpatient units at Children's Hospital and Medical Center, Omaha, NE
* have an available parent or guardian
* have an active consult request for PT or OT
* awake, alert, able to follow commands
* not delirious
* able to understand English
* free from significant vision or hearing deficits
* able to verbalize.

Exclusion Criteria:

* Have a pacemaker
* have airborne, enteric, or enhanced contact precautions
* wounds without a covering dressing or a dressing that is visibly soiled
* known adverse psychological reactions to animals
* excessive secretions via nose or mouth
* report feeling nauseated
* shows signs of acute agitation (yelling, screaming, moaning, or is otherwise inconsolable).

Primary outcomes:
measure: Pain: Wrong-Baker FACES pain rating scale
timeFrame: Change from before therapy session to immediately after therapy session is completed
measure: Anxiety: Children's Anxiety Meter-State (CAM-S)
timeFrame: Change from before therapy session to immediately after therapy session is completed.
measure: Intervention Acceptability
timeFrame: Within 1 week of study completion
measure: Hospital Acquired Infections-Central Line Associated Blood Stream Infections (CLABSI)
timeFrame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
measure: Hospital Acquired Infections-Catheter-Associated Urinary Tract Infections (CAUTI)
timeFrame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
measure: Hospital Acquired Infections-Enteroviruses
timeFrame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
measure: Hospital Acquired Infections-Influenza
timeFrame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
measure: Hospital Acquired Infections-Multi-Drug Resistant Organisms
timeFrame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
measure: Hospital Acquired Infections-Surgical-Site Infections (SSI)
timeFrame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
measure: Hospital Acquired InfectionsVentilator-Associated Pneumonia (VAP)
timeFrame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.
measure: Sedation Exposure
timeFrame: 4 hours after each individual session
measure: Microbial Contamination Screening
timeFrame: Completed immediately after each individual session
measure: Activity performance form
timeFrame: Immediately after each intervention therapy sesison
measure: Physiologic variables-Blood Pressure
timeFrame: Change from before therapy session to immediately after therapy session is completed
measure: Physiologic variables-Respiratory Rate
timeFrame: Change from before therapy session to immediately after therapy session is completed
measure: Physiologic variables
timeFrame: Change from before therapy session to immediately after therapy session is completed
measure: Opinion on Pets
timeFrame: Prior to the start of the first therapy session.
measure: Parent/Guardian Stress
timeFrame: Change from the start of the first therapy session to the end of the final therapy session.
measure: Parent/Guardian Anxiety and Depression
timeFrame: Change from the start of the first therapy session to the end of the final therapy session.
measure: Mood/Affect
timeFrame: Change from the start of the first therapy session to the end of the final therapy session.
measure: Motivation to Participate in Therapy
timeFrame: Immediately after each therapy session.
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Children's Hosptial and Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Breanna D Hetland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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