Effect of Progressive Early Mobilization in Patients With TBI

February 5, 2024 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: standard early rehabilitation (SER) group
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 progressive mobilization
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).
Experimental: early mobilization (ER) group
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 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 progressive mobilization
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
up to 3 months
the length of stay in the ICU
Time Frame: up to 3 months
the length of stay in the ICU
up to 3 months
the hospital length of stay
Time Frame: up to 3 months
the hospital length of stay
up to 3 months
the days of ventilator used
Time Frame: up to 3 months
the days of ventilator used
up to 3 months
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.
up to 3 months
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)
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
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
at baseline; at the time of ICU discharge; the time of hospital discharge
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.
at baseline; at the time of ICU discharge; the time of hospital discharge/ an average of 30 days;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hung-Jui Chuang, Dr, Department of Physical Medicine and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202012084RIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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