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Early WakingNCT04810273

Effect of Progressive Early Mobilization in Patients With TBI

A study testing Early progressive mobilization in people with Early Waking and Trauma, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Early Waking, Trauma, ICU Acquired Weakness
What is being tested?
Early progressive mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteTaiwan
Study dates
30 Mar 2021to 17 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • predicted mortality within the next 24 hours
  • palliative care
  • consistent increase of intracranial pressure (>20 mmHg)
  • pregnancy
  • uncontrolled seizure
  • active bleeding
Show all 10Show fewer
  • ruptured or leaking aortic aneurysm
  • development of acute myocardial infarction during ICU stay
  • rapid development of degenerative neuromuscular diseases
  • contraindication for early walking

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital

    Taipei, 110

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
Early progressive mobilization
Medical subject headings
Sleep Initiation and Maintenance Disorders, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early progressive mobilizationBehavioural

    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).

Study groups in NCT04810273
Study groupRoleWhat they receive
early mobilization (ER) groupExperimentalParticipants 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.
Receives: Behavioral: Early progressive mobilization
standard early rehabilitation (SER) groupActive comparatorPatients 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.
Receives: Behavioral: Early progressive mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset

Secondary outcomes (8)

  1. 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)

    Measured: at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset

  2. the achievement level of Modified Trauma ICU Mobility Scale

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

    Measured: at baseline; at the time of ICU discharge; the time of hospital discharge

  3. the days of achievement of the walking motor milestone

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

    Measured: up to 3 months

  4. 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.

    Measured: at baseline; at the time of ICU discharge; the time of hospital discharge/ an average of 30 days;

  5. the length of stay in the ICU

    the length of stay in the ICU

    Measured: up to 3 months

  6. the hospital length of stay

    the hospital length of stay

    Measured: up to 3 months

  7. the days of ventilator used

    the days of ventilator used

    Measured: up to 3 months

  8. 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.

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start30 Mar 2021
  3. Primary completion30 Jun 2021
  4. Study completion17 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04810273
Sponsor's protocol ID
202012084RIN
Status last verified
Jan 2021
First submitted
16 Mar 2021
Last updated
6 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yen HC, Chuang HJ, Hsiao WL, Tsai YC, Hsu PM, Chen WS, Han YY. Assessing the impact of early progressive mobilization on moderate-to-severe traumatic brain injury: a randomized controlled trial. Crit Care. 2024 May 22;28(1):172. doi: 10.1186/s13054-024-04940-0.

    PubMed 38778416

Questions about this trial

What is this clinical trial studying?

A study testing Early progressive mobilization in people with Early Waking and Trauma, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04810273, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.

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