Skip to main content
OpenTrials
Completed

NCT Number: NCT05275543

Robot Rehab: AAI With Robot During Inpatient Pediatric Rehab

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pediatric ALL Animal Assisted Therapy Child, Hospitalized Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Occupational Therapy Physical Therapy Modalities Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hosptial and Medical Center

Omaha, Nebraska, 68114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Paro Robot

Device

Device: PARO therapy seal PARO, a baby harp seal, is an advanced interactive, therapeutic medical robot developed by AIST, a leading Japanese industrial automation pioneer. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties.

Primary outcomes

  1. Pain: Wrong-Baker FACES pain rating scale

    Time frame: Change from before therapy session to immediately after therapy session is completed

    The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain.

  2. Anxiety: Children's Anxiety Meter-State (CAM-S)

    Time frame: Change from before therapy session to immediately after therapy session is completed.

    The CAM scale is drawn to resemble a thermometer with a bulb at the bottom and horizontal lines at intervals going up to the top. The child is instructed to indicate with a line how the child feels from from the bottom of the thermometer (not worried or nervous) to the top (very worried or nervous).

  3. Intervention Acceptability

    Time frame: Within 1 week of study completion

    Patient Satisfaction Measure: Investigator-developed Satisfaction Measure contains one item which asks the participants to rank their satisfaction with the intervention from 1-5 (not at all - very much)

  4. Hospital Acquired Infections-Central Line Associated Blood Stream Infections (CLABSI)

    Time frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.

    Rates of Central Line Associated Blood Stream Infections (CLABSI) will be collected from the electronic medical record.

  5. Hospital Acquired Infections-Catheter-Associated Urinary Tract Infections (CAUTI)

    Time frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.

    Rates of Catheter-Associated Urinary Tract Infections (CAUTI) will be collected from the electronic medical record.

  6. Hospital Acquired Infections-Enteroviruses

    Time frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.

    Rates of Enteroviruses will be collected from the electronic medical record.

  7. Hospital Acquired Infections-Influenza

    Time frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.

    Rates Influenza will be collected from the electronic medical record.

  8. Hospital Acquired Infections-Multi-Drug Resistant Organisms

    Time frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.

    Rates of Multi-Drug Resistant Organisms will be collected from the electronic medical record.

  9. Hospital Acquired Infections-Surgical-Site Infections (SSI)

    Time frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.

    Surgical-Site Infections (SSI) will be collected from the electronic medical record.

  10. Hospital Acquired InfectionsVentilator-Associated Pneumonia (VAP)

    Time frame: Chart review will be conducted from the first day the patient is enrolled until 1 week after study completion.

    Rates of Ventilator-Associated Pneumonia (VAP) will be collected from the electronic medical record.

  11. Sedation Exposure

    Time frame: 4 hours after each individual session

    Sedative and analgesic medications will be abstracted from the electronic medical record (EMR) in order to calculate sedation frequency for 4 hours after each PT/OT session in which PARO was used.

  12. Microbial Contamination Screening

    Time frame: Completed immediately after each individual session

    The ATP Monitoring with SystemSURE Plus Process uses a process which monitors levels of ATP Bioluminescence The investigators will implement established cleaning protocols and then measure ATP before the PT/OT session by swabbing PARO on the following areas: head, right flipper, left flipper, bottom [by on/off switch], top left back area, top right back area, stomach [underneath].

  13. Activity performance form

    Time frame: Immediately after each intervention therapy sesison

    The Activity Performance Form is an investigator developed measure that assesses the length of each therapy session (in minutes), the time to the patient's first out of bed movement, as well as the number and types of range of motion exercises performed (Passive, Active assist, and Active)

  14. Physiologic variables-Blood Pressure

    Time frame: Change from before therapy session to immediately after therapy session is completed

    Blood Pressure (systolic & diastolic)

  15. Physiologic variables-Respiratory Rate

    Time frame: Change from before therapy session to immediately after therapy session is completed

    Respiratory Rate

  16. Physiologic variables

    Time frame: Change from before therapy session to immediately after therapy session is completed

    Oxygen Saturation

  17. Opinion on Pets

    Time frame: Prior to the start of the first therapy session.

    18-item instrument with seven-point Likert scale (1-strongly disagree to 7-strongly agreed) designed to measure the favorableness of attitudes toward pets. Minimum Score = 18; Maximum score = 126. The higher the score, the more favorable a patient feels towards pets.

  18. Parent/Guardian Stress

    Time frame: Change from the start of the first therapy session to the end of the final therapy session.

    42-item instrument with a five-point Likert scale designed to measure stress in parents whose child has a chronic illness or requires prolonged medical monitoring. It includes four domains or subscales. Minimum Score = 42; Maximum Score = 210. Higher scores indicate higher stress.

  19. Parent/Guardian Anxiety and Depression

    Time frame: Change from the start of the first therapy session to the end of the final therapy session.

    Parent/Guardian anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). Two sub-scales (Anxiety & Depression) scored separately. Minimum Score = 0; Maximum Score = 21. Higher score = higher anxiety and/or depression

  20. Mood/Affect

    Time frame: Change from the start of the first therapy session to the end of the final therapy session.

    The PANAS-10 is a 10-item instrument that asks the child to rate adjectives of varying mood states according to how often the child feels joyful, cheerful, happy, lively, proud, miserable, mad, afraid, scared, and sad. The item response uses a five-point Likert scale ranging from 1 ("very slightly or none at all") to 5 ("extremely"). Minimum score = 10; Maximum score = 50. The higher the score, the better a child's mood/affect

  21. Motivation to Participate in Therapy

    Time frame: Immediately after each therapy session.

    19-item scale with a six-point smiley-face scale and two open-ended questions to measure motivation from a child's perspective. It has six subscales (interest/enjoyment, competence, relatedness, autonomy, value/usefulness, and effort/importance).tems in each subscale are totaled and divided by the number of items to obtain an average score per subscale. The total scores in each subscale are added to obtain and overall motivation score. Higher scores within each subscale indicate a higher level of the concept in the subscale, whereas lower scores indicate the opposite. Thus, the scores indicate differences in the quality and type of motivation for the child. In addition, a higher total score indicates greater levels of motivation, overall.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Robot Rehab: Animal Assisted Interactions With a Robotic Baby Harp Seal During Inpatient Pediatric Rehabilitation

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2022
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.