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

• ClinicalTrials.gov Identifier: NCT04524065
• Recruitment Status: Recruiting
• First Posted: August 24, 2020
• Last Update Posted: October 6, 2021
• Sponsor: Samsung Medical Center
• Information provided by (Responsible Party): Jeong Yi Kwon, Samsung Medical Center

Study Description

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 an early mobilization program and others will not.

Condition or disease	Intervention/treatment	Phase
Critical Illness	Other: Early rehabilitation protocol for children hospitalized in the PICU	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 142 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Effectiveness and Safety of an Early Mobilization Protocol in a Pediatric Intensive Care Unit
• Actual Study Start Date: October 27, 2020
• Estimated Primary Completion Date: July 1, 2022
• Estimated Study Completion Date: July 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early intervention group; 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.	Other: 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).
No Intervention: Control group; The control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.

Outcome Measures

Primary Outcome Measures :

1. Canadian Occupational Performance Measure (COPM) [ Time Frame: Baseline and 2 weeks(PICU discharge) ]
   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.

Secondary Outcome Measures :

1. Change From Baseline Functional Status Score (FSS) at Post Test(PICU discharge) [ Time Frame: Baseline and 2 weeks(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.
2. Duration of mechanical ventilation (days) [ Time Frame: 3 weeks(PICU discharge) ]
   Defined as the number of days of mechanical ventilation through an endotracheal tube during the PICU admission.
3. PICU length of stay (days) [ Time Frame: 2 weeks(PICU discharge) ]
   Defined as the number of days of PICU length of stay.
4. Hospital length of stay (days) [ Time Frame: 2 months ]
   Defined as the number of days of Hospital length of stay.
5. Number of patients discharged from the hospital to a place other than home [ Time Frame: 2 months ]
   Number of patients discharged from the hospital to a place other than home (rehabilitation facility).
6. Safety index [ Time Frame: 2 weeks(PICU discharge) ]
   • 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
7. Re-admission rate [ Time Frame: 2 months ]
   PICU re-admission rate
8. The Pediatric Risk of Mortality III (PRISM III) [ Time Frame: Baseline ]
   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).
9. Change From post-test(PICU discharge) Peabody Developmental Motor Scales-2 (PDMS-2) at follow-up test(2 months) [ Time Frame: 2 weeks(PICU discharge) and 2 months(follow-up) ]
   The PDMS-2 is a standardized, norm-referenced test, which includes gross motor and fine motor domains. All items of the PDMS-2 are scored on a 3-point scale (0 to 2): 0 is assigned when the child cannot perform the item or when the attempts do not meet the criteria of the item; 1 is assigned when the attempts do not meet for successful performance, but the behavior is emerging; and 2 indicates that the behavior is emerging, and the criterion for successful performance is fully met. The standard score and developmental age equivalent are obtained by converting the raw score of each subtest according to the criteria of the PDMS-2 manual; the standard score was used for this study. The interrater reliability and internal consistency of the fine motor domain were reported as 0.98 and 0.96, respectively. The predictive validity was reported as 0.91.
10. Change From post-test(PICU discharge) Bruininks-Oseretsky Test of Motor Proficiency, Second Edition(BOT-2) at follow-up test(2 months) [ Time Frame: 2 weeks(PICU discharge) and 2 months(follow-up) ]
    The BOT-2 quantifies motor development of children and adolescents from 4 to 21 years old. It produces a discriminative and evaluative measure of motor performances, specifically in the areas of fine motor control, manual dexterity, body coordination, strength, and agility. The BOT-2 includes 14 test items and takes only 30 min to complete. The subtests assess fine motor precision (drawing a line along a path, folding paper), fine motor integration (copying shapes), manual dexterity (transferring pennies), bilateral coordination (tapping feet and fingers, jumping in place same side synchronized), balance (walking on a line, standing on one leg on a balance beam), running speed and agility (one-legged stationary hop), upper limb coordination (dropping/catching a ball, dribbling a ball alternating hands), and strength (knee push-ups, sit-ups). All measures are converted to a normalized score, with a maximum of 88 points.
11. Change From post-test(PICU discharge) Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) at follow-up test(2 months) [ Time Frame: 2 weeks(PICU discharge) and 2 months(follow-up) ]

    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).

12. Change From post-test(PICU discharge) The Korean version of Parenting Stress Index Short Form (K-PSI-SF) at follow-up test(2 months) [ Time Frame: 2 weeks(PICU discharge) and 2 months(follow-up) ]
    The K-PSI-SF is a simplified parenting stress index developed by Lee et al. for Korean parents by standardizing the Parenting Stress Index (PSI) which was developed by Abindin in 1995. Subscales consist of 36 questions in three domains about pain of parents, dysfunctional interactions, and difficult children. Each question is measured by the five-point Likert scale: 1) strongly disagree, 2) disagree, 3) undecided, 4) agree, 5) strongly agree and the final scores are calculated by adding the point of each question.

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Jeong-Yi Kwon, PhD; +82-2-3410-2818; jeongyi.kwon@samsung.com

Contact: Young Sub Hwang, MS; +82-10-2718-2034; asiaargento@naver.com

Locations

Korea, Republic of

Samsung Medical Center; Recruiting

Seoul, Korea, Republic of, 06351

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

Principal Investigator: JEONG-YI KWON, MD

Sponsors and Collaborators

Samsung Medical Center

Investigators

• Principal Investigator: Jeong-Yi Kwon, PhD; Samsung Medical Center

More Information

• Responsible Party: Jeong Yi Kwon, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT04524065
• Other Study ID Numbers: 2020-05-136
• First Posted: August 24, 2020
• Last Update Posted: October 6, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeong Yi Kwon, Samsung Medical Center:

PICU; acute rehabilitation; early mobilization

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes