Effectiveness and Safety of an Early Mobilization Protocol in a Pediatric Intensive Care Unit

NCT ID: NCT04524065

Last Updated: 2024-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2025-12-30

Brief Summary

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This study evaluates the safety and effectiveness of an early rehabilitation program in a pediatric intensive care unit (PICU). Half of the participants will receive intensive and frequent an early mobilization program and others will receive conservative mobilization program.

Detailed Description

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The 14 early rehabilitation sessions(10=physical therapy, 4=occupational therapy) occurred per week over a 2-week period (excluding weekends) in the early rehabilitation group for 15 minutes each. The control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early intervention group

The 14 early rehabilitation sessions(10 physical therapy sessions; 15minutes per session, 4 occupational therapy sessions; 20minutes per session) occurred per week until discharge.

Group Type EXPERIMENTAL

Early rehabilitation protocol for children hospitalized in the PICU

Intervention Type OTHER

The early rehabilitation protocol was developed by a collaborative multidisciplinary team approach in Samsung Medical Center, and the central components include the involvement of physical therapy/occupational therapy (PT/OT).

Control group

The control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early rehabilitation protocol for children hospitalized in the PICU

The early rehabilitation protocol was developed by a collaborative multidisciplinary team approach in Samsung Medical Center, and the central components include the involvement of physical therapy/occupational therapy (PT/OT).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children admitted to the PICU due to critical illness
* Children aged 1-18 years

Exclusion Criteria

* Increased intracranial pressure(ICP)
* History of brain surgery
* Children with fracture
* Admitted to the participating PICU ≤ 3 days
* Children with suspected brain death
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong Yi Kwon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong-Yi Kwon, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeong-Yi Kwon, PhD

Role: CONTACT

+82-2-3410-2818

Young Sub Hwang, MS

Role: CONTACT

+82-10-2718-2034

Facility Contacts

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JEONG-YI KWON, MD, PHD

Role: primary

+8210-4591-1039

Other Identifiers

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2020-05-136

Identifier Type: -

Identifier Source: org_study_id

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