NCT04524065

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

4.8 years

First QC Date

August 19, 2020

Last Update Submit

March 12, 2024

Conditions

Critical Illness

Keywords

PICUacute rehabilitationearly mobilization

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline Functional Status Score (FSS) at Post Test(PICU discharge)

    Functional Status Scale (FSS) domains of functioning included mental status, sensory functioning, communication, motor functioning, feeding, and respiratory status, categorized from normal (score = 1) to very severe dysfunction (score = 5). FSS scores ranged from 6 to 30.

    Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da

Secondary Outcomes (12)

  • The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test(PEDI-CAT)

    Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da

  • Duration of mechanical ventilation (days)

    Perioid between intubation and extubation of mechanical ventilation

  • PICU length of stay (days)

    From PICU admission to discharge

  • Hospital length of stay (days)

    From Baseline to hospital discharge

  • Number of patients discharged from the hospital to a place other than home

    At hospital discharge

  • +7 more secondary outcomes

Study Arms (2)

Early intervention group

EXPERIMENTAL

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

Other: Early rehabilitation protocol for children hospitalized in the PICU

Control group

NO INTERVENTION

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

Interventions

Early rehabilitation protocol for children hospitalized in the PICUOTHER

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).

Early intervention group

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeong-Yi Kwon, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeong-Yi Kwon, PhD

CONTACT

+82-2-3410-2818jeongyi.kwon@samsung.com

Young Sub Hwang, MS

CONTACT

+82-10-2718-2034asiaargento@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2020

First Posted

August 24, 2020

Study Start

October 27, 2020

Primary Completion

August 30, 2025

Study Completion

December 30, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

KR(1)