Clinical trial NCT04810273: Effect of Progressive Early Mobilization in Patients With TBI
Official title: Effect of Progressive Early Mobilization on Functional Recovery in Patients With Moderate-Severe Traumatic Brain Injury: a Single Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Waking
Trauma
ICU Acquired Weakness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The total score-change of the Perme ICU Mobility Score
timeFrame: at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset
Secondary outcomes:
measure: The total score-change of the motor domain of the Functional Independence Measure (FIM-motor)
timeFrame: at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset
measure: the achievement level of Modified Trauma ICU Mobility Scale
timeFrame: at baseline; at the time of ICU discharge; the time of hospital discharge
measure: the days of achievement of the walking motor milestone
timeFrame: up to 3 months
measure: the values tested by in body s10 about lean body mass parameters
timeFrame: at baseline; at the time of ICU discharge; the time of hospital discharge/ an average of 30 days;
measure: the length of stay in the ICU
timeFrame: up to 3 months
measure: the hospital length of stay
timeFrame: up to 3 months
measure: the days of ventilator used
timeFrame: up to 3 months
measure: the discharge disposition after hospital discharge
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation
name: Hung-Jui Chuang, Dr
role: PRINCIPAL_INVESTIGATOR
References: