Robot Rehab: AAI With Robot During Inpatient Pediatric Rehab

NCT ID: NCT05275543

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-01-03

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physical and Occupational Therapy with Paro Robot

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

Group Type: EXPERIMENTAL

Paro Robot

Intervention Type: 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.

Physical and Occupational Therapy without Paro Robot

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Parents/Guardians of Hospitalized Children who use Paro Robot

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

Group Type: EXPERIMENTAL

Paro Robot

Intervention Type: 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 do not use Paro Robot

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Paro Robot

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.

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Breanna D Hetland, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Children's Hosptial and Medical Center

Omaha, Nebraska, United States

Countries

United States

References

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

Reference Type: 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.

Reference Type: 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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26956570 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29276432 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 11259517 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 12914662 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 3344163 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24094126 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26281433 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30540694 (View on PubMed)

Other Identifiers

0010-22-EP

Identifier Type: -

Identifier Source: org_study_id