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NCT Number: NCT04810273

Effect of Progressive Early Mobilization in Patients With TBI

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.

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Key information

Conditions

Early Waking Dyssomnias ICU Acquired Weakness Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Trauma Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early progressive mobilization

Behavioral

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).

Primary outcomes

  1. The total score-change of the Perme ICU Mobility Score

    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 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 outcomes

  1. The total score-change of the motor domain of the Functional Independence Measure (FIM-motor)

    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 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)

  2. the achievement level of Modified Trauma ICU Mobility Scale

    Time frame: at baseline; at the time of ICU discharge; the time of hospital discharge

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

  3. the days of achievement of the walking motor milestone

    Time frame: up to 3 months

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

  4. the values tested by in body s10 about lean body mass parameters

    Time frame: at 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.

  5. the length of stay in the ICU

    Time frame: up to 3 months

    the length of stay in the ICU

  6. the hospital length of stay

    Time frame: up to 3 months

    the hospital length of stay

  7. the days of ventilator used

    Time frame: up to 3 months

    the days of ventilator used

  8. the discharge disposition after hospital discharge

    Time frame: up to 3 months

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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2024
First posted
Mar 22, 2021
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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