Effectiveness and Safety of an Early Mobilization Protocol in a Pediatric Intensive Care Unit
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Samsung Medical Center
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Change From Baseline Functional Status Score (FSS) at Post Test(PICU discharge)
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Early rehabilitation protocol for children hospitalized in the PICU (Other)
Control group
The control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Hospital length of stay (days)(From Baseline to hospital discharge)
- PICU length of stay (days)(From PICU admission to discharge)
- Canadian Occupational Performance Measure (COPM)(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)
- 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)
- The Pediatric Risk of Mortality III (PRISM III)(At PICU admission)
- Muscle strength measures of elbow flexor and knee extensor obtained with a hand-held dynamometer(MicroFET2).(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)
- Pediatric Sequential Organ Failure Assessment(pSOFA)(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)
- Safety index(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)
- Number of patients discharged from the hospital to a place other than home(At hospital discharge)
- Change From post-test(PICU discharge) Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) at follow-up test(2 months)(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)
- Change From baseline The State-Trait Anxiety Inventory (STAI) at follow-up test(2 months)(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)
Investigators
Jeong Yi Kwon
Professor
Samsung Medical Center