Effect of Progressive Early Mobilization in Patients With TBI

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Early Waking, Trauma, ICU Acquired Weakness

Intervention / Treatment
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* Behavioral: Early mobilization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early mobilization (ER) group<br>Participants in the EM group will undergo the progressive early mobilization protocol in the trauma ICU in a manner consistent with the our hospital practice guidelines indicated by the Modified Trauma ICU Mobility Scale for progressive mobilization during the ICU stay. EM will be started with in-bed exercises and, if no medical contraindications are present, progressed from sitting in bed with the head tilted >60° to sitting on the edge of the bed to standing (including pre-gait exercises to improve postural stability, static and dynamic balance, and marching on the spot) and, finally, to walking. | Behavioral: Early mobilization<br>* 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 5 days).<br>|
| Active Comparator: standard early rehabilitation (SER) group<br>Patients in the SER group (Progressive upright positioning protocol) will receive standard physiotherapy including passive range of motion exercises, active exercises, bed mobility, and respiratory therapy during their ICU stays. In the SER group, out-of-bed mobilization (>=Level III in the Modified Trauma ICU Mobility Scale) will be started as soon as possible after ICU discharge but at least Level III (sitting on the edge of bed) above 7 days of onset. | Behavioral: Early mobilization<br>* 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 5 days).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total score-change of 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, an average of 14 days; the time of hospital discharge (an average of 30 days); three-month after onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total score-change of 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, an average of 14 days; the time of hospital discharge (an average of 30 days); three-month after onset | 
| 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, an average of 14 days; the time of hospital discharge, an average of 50 days | 
| 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 | 
| 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/ an average of 14 days; the time of hospital discharge/ an average of 30 days; | 
| the length of stay in the ICU | the length of stay in the ICU | up to 3 months | 
| the hospital length of stay | the hospital length of stay | up to 3 months | 
| the days of ventilator used | the days of ventilator used | up to 3 months | 
| 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 |