Effect of Progressive Early Mobilization in Patients With TBI

NCT04810273 | Completed

• 1 other identifier: 202012084RIN
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Waking; Trauma; ICU Acquired Weakness

Outcome Measures

Primary Outcomes (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.

  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)

• 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 achievement level of Modified Trauma ICU Mobility Scale

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

• the days of achievement of the walking motor milestone

  up to 3 months

• the values tested by in body s10 about lean body mass parameters

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

• the length of stay in the ICU

  up to 3 months

Study Arms (2)

early mobilization (ER) group

EXPERIMENTAL

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

standard early rehabilitation (SER) group

ACTIVE COMPARATOR

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

Interventions

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).

early mobilization (ER) group; standard early rehabilitation (SER) group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 110, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38778416 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Hung-Jui Chuang, Dr

  Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: March 30, 2021
• Primary Completion: June 30, 2021
• Study Completion: January 17, 2024
• Last Updated: February 6, 2024

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)