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Effect of Progressive Early Mobilization in Patients With TBI

Not Applicable
Completed
Conditions
Trauma
Early Waking
ICU Acquired Weakness
Interventions
Behavioral: Early progressive mobilization
Registration Number
NCT04810273
Lead Sponsor
National Taiwan University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
65
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)
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
standard early rehabilitation (SER) groupEarly progressive mobilizationPatients 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.
early mobilization (ER) groupEarly progressive mobilizationParticipants 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 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.
Primary Outcome Measures
NameTimeMethod
The total score-change of the Perme ICU Mobility Scoreat baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset

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.

Secondary Outcome Measures
NameTimeMethod
the achievement level of Modified Trauma ICU Mobility Scaleat baseline; at the time of ICU discharge; the time of hospital discharge

the achievement of Modified Trauma ICU Mobility Scale, Level 0-10

the hospital length of stayup to 3 months

the hospital length of stay

the values tested by in body s10 about lean body mass parametersat baseline; at the time of ICU discharge; the time of hospital discharge/ an average of 30 days;

including phase angle, skeletal muscle mass, body fat mass, total body water etc.

The total score-change of the motor domain of the Functional Independence Measure (FIM-motor)at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset

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)

the days of achievement of the walking motor milestoneup to 3 months

walking on a level surface for ≥50 meters with or without an assistive device

the days of ventilator usedup to 3 months

the days of ventilator used

the length of stay in the ICUup to 3 months

the length of stay in the ICU

the discharge disposition after hospital dischargeup to 3 months

where a patient is being discharged - i.e. home, home with home care, skilled nursing facility, or rehab center.

Trial Locations

Locations (1)

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

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