Effect of Progressive Early Mobilization in Patients With TBI

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: Completed
• Conditions: Trauma; ICU Acquired Weakness; Early Waking
• Intervention / Treatment: Behavioral: Early progressive mobilization

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: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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

Outcome Measure	Measure Description	Time Frame
the days of achievement of the walking motor milestone	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	the length of stay in the ICU	up to 3 months
the hospital length of stay	the hospital length of stay	up to 3 months
the days of ventilator used	the days of ventilator used	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.	up to 3 months
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)	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	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	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

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hung-Jui Chuang, Dr, Department of Physical Medicine and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID 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