Robot Rehab: AAI With Robot During Inpatient Pediatric Rehab

NCT05275543 | Completed FDA Device

• 1 other identifier: 0010-22-EP
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric ALL; Child, Hospitalized; Physical Therapy Modalities; Occupational Therapy; Animal Assisted Therapy

Keywords

Robot; Animal Assisted Interaction; Hosptilization; Rehabiliation; Pediatric

Outcome Measures

Primary Outcomes (21)

• Pain: Wrong-Baker FACES pain rating scale

  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.

  Change from before therapy session to immediately after therapy session is completed

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

  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).

  Change from before therapy session to immediately after therapy session is completed.

• Intervention Acceptability

  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)

  Within 1 week of study completion

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

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

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

• Hospital Acquired Infections-Catheter-Associated Urinary Tract Infections (CAUTI)

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

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

• Hospital Acquired Infections-Enteroviruses

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

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

• Hospital Acquired Infections-Influenza

  Rates Influenza will be collected from the electronic medical record.

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

• Hospital Acquired Infections-Multi-Drug Resistant Organisms

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

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

• Hospital Acquired Infections-Surgical-Site Infections (SSI)

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

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

• Hospital Acquired InfectionsVentilator-Associated Pneumonia (VAP)

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

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

• Sedation Exposure

  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.

  4 hours after each individual session

• Microbial Contamination Screening

  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 \[underneath\].

  Completed immediately after each individual session

• Activity performance form

  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)

  Immediately after each intervention therapy sesison

• Physiologic variables-Blood Pressure

  Blood Pressure (systolic \& diastolic)

  Change from before therapy session to immediately after therapy session is completed

• Physiologic variables-Respiratory Rate

  Respiratory Rate

  Change from before therapy session to immediately after therapy session is completed

• Physiologic variables

  Oxygen Saturation

  Change from before therapy session to immediately after therapy session is completed

• Opinion on Pets

  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.

  Prior to the start of the first therapy session.

• Parent/Guardian Stress

  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.

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

• Parent/Guardian Anxiety and Depression

  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

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

• Mood/Affect

  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

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

• Motivation to Participate in Therapy

  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.

  Immediately after each therapy session.

Study Arms (4)

Physical and Occupational Therapy with Paro Robot

EXPERIMENTAL

10-30 minute semi-structured, prescriptive therapy sessions with Paro robot focused on the categories of 1) speech; 2) balance and endurance; 3) memory; 4) self-esteem; 5) fine motor; 6) sensory stimulation

Device: Paro Robot

Physical and Occupational Therapy without Paro Robot

NO INTERVENTION

10-30 minute semi-structured, prescriptive therapy sessions without Paro robot focused on the categories of 1) speech; 2) balance and endurance; 3) memory; 4) self-esteem; 5) fine motor; 6) sensory stimulation

Parents/Guardians of Hospitalized Children who use Paro Robot

EXPERIMENTAL

Parents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with Paro Robot"

Device: Paro Robot

Parents/Guardians of Hospitalized Children who do not use Paro Robot

NO INTERVENTION

Parents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with out Paro Robot"

Interventions

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.

Parents/Guardians of Hospitalized Children who use Paro Robot; Physical and Occupational Therapy with Paro Robot

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Children's Hosptial and Medical Center

Omaha, Nebraska, 68114, United States

Location

Related Publications (13)

• Fine AH. Handbook on Animal-Assisted Therapy: Theoretical Foundations and Guidelines for Practice. 4th ed. Burlington, MA: Academic Press; 2015

  BACKGROUND

• Bailey T, Christenson G, Lust K. The role of an animal-assisted interaction (AAI) program as a means of reducing stress and anxiety within a college community. Oxford, UK: Inter-Disciplinary Press.

  BACKGROUND

• Bailey T. Animal-assisted interactions (AAI): a creative modality to support youth with depression. In: Brooke SL, Myers CE, eds. The Use of the Creative Therapies in Treating Depression. Springfield, IL: Charles C. Thomas; 2015:269.

  BACKGROUND

• Burres S, Edwards NE, Beck AM, Richards E. Incorporating Pets into Acute Inpatient Rehabilitation: A Case Study. Rehabil Nurs. 2016 Nov;41(6):336-341. doi: 10.1002/rnj.260. Epub 2016 Mar 9.

  PMID: 26956570 BACKGROUND

• Hetland B, Bailey T, Prince-Paul M. Animal Assisted Interactions to Alleviate Psychological Symptoms in Patients on Mechanical Ventilation. J Hosp Palliat Nurs. 2017 Dec;19(6):516-523.

  PMID: 29276432 BACKGROUND

• Templer D.I., Arikawa H. (2011) The Pet Attitude Scale. In: Blazina C., Boyraz G., Shen-Miller D. (eds) The Psychology of the Human-Animal Bond. Springer, New York, NY. https://doi.org/10.1007/978-14419-9761-6_20

  BACKGROUND

• Streisand R, Braniecki S, Tercyak KP, Kazak AE. Childhood illness-related parenting stress: the pediatric inventory for parents. J Pediatr Psychol. 2001 Apr-May;26(3):155-62. doi: 10.1093/jpepsy/26.3.155.

  PMID: 11259517 BACKGROUND

• Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

  PMID: 12914662 BACKGROUND

• Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.

  PMID: 3344163 BACKGROUND

• Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.

  PMID: 24094126 BACKGROUND

• Ebesutani C, Regan J, Smith A, Reise S, Higa-McMillan C, Chorpita BF. The 10-item positive and negative affect schedule for children, child and parent shortened versions: Application of item response theory for more efficient assessment. J of Psychopathol. Behav. Assess. 2012; 34(2), 191-203.

  BACKGROUND

• Tatla SK, Jarus T, Virji-Babul N, Holsti L. The development of the Pediatric Motivation Scale for rehabilitation. Can J Occup Ther. 2015 Apr;82(2):93-105. doi: 10.1177/0008417414556884.

  PMID: 26281433 BACKGROUND

• Tracy MF, Chlan L, Savik K, Skaar DJ, Weinert C. A Novel Research Method for Determining Sedative Exposure in Critically Ill Patients. Nurs Res. 2019 Jan/Feb;68(1):73-79. doi: 10.1097/NNR.0000000000000322.

  PMID: 30540694 BACKGROUND

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Breanna D Hetland, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial with Repeated Measures

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 11, 2022
• Study Start: April 1, 2022
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)