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

Samsung Medical Center

Status: Enrolling

Conditions: Critical Illness

Treatments: Other: Early rehabilitation protocol for children hospitalized in the PICU

Study type: Interventional

Funder types: Other

Identifiers

NCT04524065

2020-05-136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

142 participants in 2 patient groups

Early intervention group

Experimental group

Description:

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

Treatment:

Other: Early rehabilitation protocol for children hospitalized in the PICU

Control group

No Intervention group

Description:

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