A Korean Point Prevalence Study of Acute Rehabilitation for Kids in the PICU (PARK-PICU)

June 1, 2026 updated by: Jeong Yi Kwon, Samsung Medical Center

Prevalence of Acute Rehabilitation for Kids in the Pediatric Intensive Care Unit

This study investigates the prevalence of acute rehabilitation practices among children in pediatric intensive care units (PICUs).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective observational study conducted across 13 hospitals. Data will be collected at three predefined time points to assess the prevalence of acute rehabilitation practices among children in pediatric intensive care units.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
396

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
    • Daegu
      • Daegu, Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
        • Contact:
    • Daejeon
      • Daejeon, Daejeon, South Korea, 35015
        • Chungnam National University Hospital
        • Contact:
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
        • Contact:
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Pusan National University Yangsan Hospital
        • Contact:
    • Incheon
      • Incheon, Incheon, South Korea, 22332
        • Inha University Hospital
        • Contact:
    • Jeju-do
      • Jeju City, Jeju-do, South Korea, 63241
        • Jeju National University Hospital
        • Contact:
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, South Korea, 54907
        • Jeonbuk National University Hospital
        • Contact:
    • Jeollanam-do
      • Hwasun, Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
        • Contact:
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Seoul National University Hospital
        • Contact:
      • Seoul, Seoul, South Korea, 05505
      • Seoul, Seoul, South Korea, 06351
        • Samsung Medical Center
        • Contact:
      • Seoul, Seoul, South Korea, 03722
        • Severance Hospital
        • Contact:
      • Seoul, Seoul, South Korea, 06591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study population includes critically ill children and adolescents aged 18 years or younger who are admitted to pediatric intensive care units (PICUs) at participating hospitals in South Korea. Patients who have been hospitalized in the PICU for at least 72 hours as of 9:00 AM on predefined study dates will be included. All eligible patients at each study time point will be included to reflect real-world clinical practice in pediatric critical care.

Description

Inclusion Criteria:

  • Children and adolescents aged 18 years or younger who have been admitted to the pediatric intensive care unit (PICU) for at least 72 hours as of 9:00 AM on the predefined study date at participating hospitals.

Exclusion Criteria:

  • No exclusion criteria. All eligible patients meeting the inclusion criteria will be included to comprehensively assess the real-world prevalence of acute rehabilitation practices and associated barriers in pediatric intensive care units.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Children in Pediatric Intensive Care Units
Children admitted to pediatric intensive care units (PICUs) who are assessed for the prevalence of acute rehabilitation practices during critical care.
Other: Acute Rehabilitation (Observed Practice)
This study does not assign any interventions. It observes routine clinical practices of acute rehabilitation provided to children in pediatric intensive care units as part of standard care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Who Received Acute Rehabilitation
Time Frame: At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
Prevalence is defined as the proportion of eligible children in the pediatric intensive care unit who received at least one session of physical therapy or occupational therapy within the 24 hours preceding each study assessment point.
At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Acute Rehabilitation Sessions per Participant
Time Frame: At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
The number of physical therapy or occupational therapy sessions delivered to eligible children within the 24 hours preceding each assessment point.
At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
Number of Participants by Type of Rehabilitation Intervention
Time Frame: At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
The types of rehabilitation interventions delivered within the 24 hours preceding each assessment point, including passive exercise, active exercise, positioning, mobility training, and occupational therapy interventions.
At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
Proportion of sessions Involving Assistive Devices
Time Frame: At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
The proportion of rehabilitation sessions involving assistive devices or equipment during the 24 hours preceding each assessment point.
At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
Number of Sessions by Delivery Method
Time Frame: At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
The types of rehabilitation delivery methods used within the 24 hours preceding each assessment point, including bedside therapy, in-room mobilization, and therapist-assisted mobility interventions.
At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
Odds Ratios for Factors Associated With Absence of Acute Rehabilitation
Time Frame: At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period
Multivariable logistic regression analysis will be performed to evaluate clinical and organizational factors associated with the absence of acute rehabilitation delivery among eligible children in the pediatric intensive care unit. Predictor variables will include patient demographics, severity of illness, sedation status, mechanical ventilation, restraint use, ICU structure, rehabilitation protocols, and staffing resources.
At three seasonal point-prevalence assessments conducted approximately 6 months apart over an 18-month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-03-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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