AzTrials
AzTrials

Critical IllnessNCT04524065

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

A study testing Early rehabilitation protocol for children hospitalized in the PICU in people with Critical Illness, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Critical Illness
What is being tested?
Early rehabilitation protocol for children hospitalized in the PICU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteSouth Korea
Study dates
27 Oct 2020to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jeong-Yi Kwon, PhD contact

+82-2-3410-2818

jeongyi.kwon@samsung.com

Young Sub Hwang, MS contact

+82-10-2718-2034

asiaargento@naver.com

South Korea1 site, 1 recruiting
  • Samsung Medical Center

    Seoul, 06351

    JEONG-YI KWON, MD, PHD, +8210-4591-1039, jeongyi.kwon@samsung.com

    JEONG-YI KWON, MD

    Recruiting

Other trials in South Korea

About this study

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.

Read the detailed description

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.

Being tested
Early rehabilitation protocol for children hospitalized in the PICU
Keywords
PICU, acute rehabilitation, early mobilization
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT04524065
Study groupRoleWhat they receive
Early intervention groupExperimentalThe 14 early rehabilitation sessions(10 physical therapy sessions; 15minutes per session, 4 occupational therapy sessions; 20minutes per session) occurred per week until discharge.
Receives: Other: Early rehabilitation protocol for children hospitalized in the PICU
Control groupNo interventionThe control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test(PEDI-CAT)

    The PEDI-CAT incorporates a computer-adaptive platform with 276 items based on parental or caregiver reporting, and has four domains that cover daily activities, mobility, social/cognitive function, and responsibility. The PEDI-CAT yields a single score scaled from 0 to 100 for both Mobility and Self-care, with higher scores indicating greater function.

    Measured: 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

  2. Duration of mechanical ventilation (days)

    Defined as the number of days of mechanical ventilation through an endotracheal tube during the PICU admission.

    Measured: Perioid between intubation and extubation of mechanical ventilation

  3. PICU length of stay (days)

    Defined as the number of days of PICU length of stay.

    Measured: From PICU admission to discharge

  4. Hospital length of stay (days)

    Defined as the number of days of Hospital length of stay.

    Measured: From Baseline to hospital discharge

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

    Number of patients discharged from the hospital to a place other than home (rehabilitation facility).

    Measured: At hospital discharge

  6. Safety index

    • Frequency of thrombus and pressure sores occurred during intervention period
    • Frequency of abnormal vital signs occurred during intervention period
    • Frequency of any adverse events associated with intervention

    Measured: 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

  7. The Pediatric Risk of Mortality III (PRISM III)

    The PRISM III score has 17 physiologic variables subdivided into 26 ranges. The variables most predictive of mortality were minimum systolic blood pressure, abnormal pupillary reflexes, and stupor/coma. Other risk factors, including two acute and two chronic diagnoses, and four additional risk factors, were used in the final predictors. The PRISM III score and the additional risk factors were applied to the first 24 hours of stay (PRISM III-24).

    Measured: At PICU admission

  8. Change From post-test(PICU discharge) Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) at follow-up test(2 months)

    The Pediatric Quality of Life Inventory or PedsQLTM is a series of assessment instruments designed to measure the health-related quality of life of children. The PedsQL 4.0 provides an opportunity for the assessment of both overall (generic) quality of life as well as disease-specific quality of life.

    The PedsQL 4.0 Generic Core Scales are appropriate for assessing health-related quality of life in both healthy and chronically ill children. The four scales making up this generic battery include Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items).

    A 5-point response scale is utilized across child self-report and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 =almost always a problem).

    Measured: 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

  9. Change From baseline The State-Trait Anxiety Inventory (STAI) at follow-up test(2 months)

    The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety. STAI-X consists of 20 items each for measuring state anxiety and trait anxiety. Each item is rated on a 4-point scale (1 = Not at all, 4 = Very much so), with scores ranging from 20 to 80.

    Measured: 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

  10. Canadian Occupational Performance Measure (COPM)

    At baseline, the interviewer assisted the child and family to identify occupational performance problems in the areas of self-care, productivity or leisure. Once they had identified these problems, they were written positively as goals, which participants and their parents then prioritised by importance on a scale from 1 to 10 (10 indicating greater importance). Scores out of 10 for self-perceived performance and satisfaction were then obtained from parent. The scores were summed and averaged over the number of priorities identified to produce two overall scores out of 10 for each participant: one for performance and one for satisfaction. At post-treatment and follow-up, participants were blinded to their previous ratings in order to limit potential bias. A 2 point change in score on the COPM is considered to be clinically meaningful.

    Measured: 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

  11. Muscle strength measures of elbow flexor and knee extensor obtained with a hand-held dynamometer(MicroFET2).

    Maximal isometric voluntary contraction will be measured with a MicroFET2 hand-held dynamometer (Hoggan Indiustries, Inc., West Jordan, UT, USA). Maximal isometric muscle strength from two different muscle groups (knee extensors and elbow flexors) will be measured. It will be performed twice for each motion, and the higher one is derived as the result. Higher values indicates higher strength.

    Measured: 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

  12. Pediatric Sequential Organ Failure Assessment(pSOFA)

    The Pediatric Sequential Organ Failure Assessment (pSOFA) score is a simple and objective score that allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic) and the score can measure individual or aggregate organ dysfunction. Daily pSOFA score is the sum of the 6 subscores and higher scores indicate a worse outcome. Score assesses 6 organ systems: respiratory, hematological, hepatic, cardiovascular, neurological and renal. A subscore of 0 (normal)-4(most abnormal) points.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2020
  2. Study start27 Oct 2020
  3. Primary completion30 Aug 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04524065
Sponsor's protocol ID
2020-05-136
Status last verified
Mar 2024
First submitted
19 Aug 2020
Last updated
15 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Early rehabilitation protocol for children hospitalized in the PICU in people with Critical Illness, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jeong-Yi Kwon, PhD (+82-2-3410-2818, jeongyi.kwon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline Functional Status Score (FSS) at Post Test(PICU discharge) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in