Effect of Progressive Early Mobilization in Patients With TBI

Trauma Clinical Trial

Official title:

Effect of Progressive Early Mobilization on Functional Recovery in Patients With Moderate-Severe Traumatic Brain Injury: a Single Blind, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810273
• Other study ID #: 202012084RIN
• Status: Completed
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: January 17, 2024

Study information

• Verified date: January 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

traumatic brain injury (TBI) is a major public health concern worldwide. Patients with moderate-severe TBI have high rates of disability at the acute phase and frequently require protracted rehabilitation with prolonged periods of recovery. Recently, it has been found that the use of progressive early mobilization (EM) protocols for critical trauma patients may minimize the functional declines during intensive care unit (ICU) stays. However, prior early mobilization studies have found that the survivors of moderate-severe TBI often experience a greater incidence of neurological injuries with other organ injury than other critical care patients. No randomized controlled trials thus far have utilized measure the influence or effect of early progressive EM protocols on the functional recovery of moderate-severe TBI patients.

Description:

Objective: The goals of this proposed research study are (1) to investigate the feasibility of using a structured progressive EM protocol for patients with moderate-severe TBI in a trauma ICU and (2) The goal is to investigate and compare the intervention effects of a progressive EM protocol (aimed at bringing patients at least to the mobility level-3 of sitting on the edge of bed) in an ICU on short-term and long-term functional abilities in patients with moderate-severe TBI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 17, 2024
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Expected to stay for at least 72 hours in the ICU,

• >20 years of age with living independently before the onset of critical illness

• relatively stable vital signs with a Glasgow Coma Scale (GCS) score of =6

• relatively stable respiratory status (SpO2 >92%, high mechanical ventilator setting:

FiO2 =60%, and positive end-expiratory pressure =10 cmH2O)

• stable cardiovascular system (resting heart rate =130 bpm or no use of high-dose vasopressor of more than 0.2 µg kg-1 min-1)

Exclusion Criteria:

• predicted mortality within the next 24 hours

• palliative care

• consistent increase of intracranial pressure (>20 mmHg)

• pregnancy

• uncontrolled seizure

• active bleeding

• ruptured or leaking aortic aneurysm

• development of acute myocardial infarction during ICU stay

• rapid development of degenerative neuromuscular diseases

• contraindication for early walking

Related Conditions & MeSH terms

• Early Waking
• ICU Acquired Weakness
• Trauma

Intervention

Behavioral:
• Early progressive mobilization
The goal will be to achieve a mobilization level of at least Level III (sitting on the edge of bed) during the ICU stay (within 7 days).

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total score-change of the Perme ICU Mobility Score	The Perme ICU Mobility Score ranges from 0 to 32 points and is obtained by summing the score of 15 items, each one scored from 2 to 3 points. This score reflects the patient's mobility status in specific circumstances.	at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset
Secondary	The total score-change of the motor domain of the Functional Independence Measure (FIM-motor)	the FIM-motor consist of self-care tasks (eating, grooming, bathing, upper-body dressing, lower-body dressing, and using the toilet), sphincter control (bladder and bowel management), transfers (from bed or a chair to the toilet, bath, or shower), and locomotion ability (walking or wheelchair mobility, and stair climbing)	at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset
Secondary	the achievement level of Modified Trauma ICU Mobility Scale	the achievement of Modified Trauma ICU Mobility Scale, Level 0-10	at baseline; at the time of ICU discharge; the time of hospital discharge
Secondary	the days of achievement of the walking motor milestone	walking on a level surface for =50 meters with or without an assistive device	up to 3 months
Secondary	the values tested by in body s10 about lean body mass parameters	including phase angle, skeletal muscle mass, body fat mass, total body water etc.	at baseline; at the time of ICU discharge; the time of hospital discharge/ an average of 30 days;
Secondary	the length of stay in the ICU	the length of stay in the ICU	up to 3 months
Secondary	the hospital length of stay	the hospital length of stay	up to 3 months
Secondary	the days of ventilator used	the days of ventilator used	up to 3 months
Secondary	the discharge disposition after hospital discharge	where a patient is being discharged - i.e. home, home with home care, skilled nursing facility, or rehab center.	up to 3 months