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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
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).
National Taiwan University Hospital
Taipei, Taiwan
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.
Time frame: at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset
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)
Time frame: at baseline; at the time of ICU discharge; 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
Time frame: at baseline; at the time of ICU discharge; the time of hospital discharge
the days of achievement of the walking motor milestone
walking on a level surface for ≥50 meters with or without an assistive device
Time frame: 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.
Time frame: at baseline; at the time of ICU discharge; the time of hospital discharge/ an average of 30 days;
the length of stay in the ICU
the length of stay in the ICU
Time frame: up to 3 months
the hospital length of stay
the hospital length of stay
Time frame: up to 3 months
the days of ventilator used
the days of ventilator used
Time frame: 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.
Time frame: up to 3 months
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