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

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Early rehabilitation protocol for children hospitalized in the PICU
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Critical Illness focused on measuring PICU, acute rehabilitation, early mobilization

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early intervention group

Control group

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Duration of mechanical ventilation (days)
Defined as the number of days of mechanical ventilation through an endotracheal tube during the PICU admission.
PICU length of stay (days)
Defined as the number of days of PICU length of stay.
Hospital length of stay (days)
Defined as the number of days of Hospital length of stay.
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).
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
Re-admission rate
PICU re-admission rate
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).
Change From post-test(PICU discharge) Peabody Developmental Motor Scales-2 (PDMS-2) at follow-up test(2 months)
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.
Change From post-test(PICU discharge) Bruininks-Oseretsky Test of Motor Proficiency, Second Edition(BOT-2) at follow-up test(2 months)
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.
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).
Change From post-test(PICU discharge) The Korean version of Parenting Stress Index Short Form (K-PSI-SF) at follow-up test(2 months)
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.

Full Information

First Posted
August 19, 2020
Last Updated
October 4, 2021
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04524065
Brief Title
Effectiveness and Safety of an Early Mobilization Protocol in a Pediatric Intensive Care Unit
Official Title
Effectiveness and Safety of an Early Mobilization Protocol in a Pediatric Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
PICU, acute rehabilitation, early mobilization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early intervention group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.
Intervention Type
Other
Intervention Name(s)
Early rehabilitation protocol for children hospitalized in the PICU
Intervention Description
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).
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Baseline and 2 weeks(PICU discharge)
Secondary Outcome Measure Information:
Title
Change From Baseline Functional Status Score (FSS) at Post Test(PICU discharge)
Description
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.
Time Frame
Baseline and 2 weeks(PICU discharge)
Title
Duration of mechanical ventilation (days)
Description
Defined as the number of days of mechanical ventilation through an endotracheal tube during the PICU admission.
Time Frame
3 weeks(PICU discharge)
Title
PICU length of stay (days)
Description
Defined as the number of days of PICU length of stay.
Time Frame
2 weeks(PICU discharge)
Title
Hospital length of stay (days)
Description
Defined as the number of days of Hospital length of stay.
Time Frame
2 months
Title
Number of patients discharged from the hospital to a place other than home
Description
Number of patients discharged from the hospital to a place other than home (rehabilitation facility).
Time Frame
2 months
Title
Safety index
Description
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
Time Frame
2 weeks(PICU discharge)
Title
Re-admission rate
Description
PICU re-admission rate
Time Frame
2 months
Title
The Pediatric Risk of Mortality III (PRISM III)
Description
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).
Time Frame
Baseline
Title
Change From post-test(PICU discharge) Peabody Developmental Motor Scales-2 (PDMS-2) at follow-up test(2 months)
Description
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.
Time Frame
2 weeks(PICU discharge) and 2 months(follow-up)
Title
Change From post-test(PICU discharge) Bruininks-Oseretsky Test of Motor Proficiency, Second Edition(BOT-2) at follow-up test(2 months)
Description
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.
Time Frame
2 weeks(PICU discharge) and 2 months(follow-up)
Title
Change From post-test(PICU discharge) Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) at follow-up test(2 months)
Description
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).
Time Frame
2 weeks(PICU discharge) and 2 months(follow-up)
Title
Change From post-test(PICU discharge) The Korean version of Parenting Stress Index Short Form (K-PSI-SF) at follow-up test(2 months)
Description
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.
Time Frame
2 weeks(PICU discharge) and 2 months(follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Yi Kwon, PhD
Phone
+82-2-3410-2818
Email
jeongyi.kwon@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Young Sub Hwang, MS
Phone
+82-10-2718-2034
Email
asiaargento@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Yi Kwon, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD, PHD
Phone
+8210-4591-1039
Email
jeongyi.kwon@samsung.com
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD

12. IPD Sharing Statement

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

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