25 Participants Needed

Robotic Therapy for Hospitalized Children

BH
BD
Overseen ByBreanna D Hetland, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

BD

Breanna D Hetland, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for children aged 5-18 hospitalized at Children's Hospital and Medical Center in Omaha, NE. They must be awake, alert, able to follow commands and communicate verbally, with an active PT or OT consult request. A parent or guardian needs to be available, and they should not have significant vision/hearing issues or delirium.

Inclusion Criteria

Admitted to any of the five inpatient units at Children's Hospital and Medical Center, Omaha, NE
Have an available parent or guardian
I have a current referral for physical or occupational therapy.
See 5 more

Exclusion Criteria

I feel nauseated.
My wound is exposed or has a dirty bandage.
Known adverse psychological reactions to animals
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 10-30 minute semi-structured, prescriptive physical and occupational therapy sessions with or without the Paro robot, focusing on speech, balance and endurance, memory, self-esteem, fine motor skills, and sensory stimulation.

Varies per participant
Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including chart reviews for hospital-acquired infections and other health metrics.

1 week after study completion

Treatment Details

Interventions

  • Paro Robot
Trial Overview The study tests the use of a robotic baby harp seal (Paro Robot) during pediatric inpatient physical therapy (PT) and occupational therapy (OT). It aims to see if interacting with Paro makes kids less anxious and more motivated during rehab sessions compared to those without it.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: Physical and Occupational Therapy with Paro RobotExperimental Treatment1 Intervention
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 II: Parents/Guardians of Hospitalized Children who use Paro RobotExperimental Treatment1 Intervention
Parents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with Paro Robot"
Group III: Physical and Occupational Therapy without Paro RobotActive Control1 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
Group IV: Parents/Guardians of Hospitalized Children who do not use Paro RobotActive Control1 Intervention
Parents/guardians of hospitalized children who are assigned to the following arm "Physical and Occupational Therapy with out Paro Robot"

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Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+
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