Effect of Progressive Early Mobilization in Patients With TBI

NCT ID: NCT04810273

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2024-01-17

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.

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.

Conditions

Early Waking; Trauma; ICU Acquired Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Early progressive mobilization

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Early progressive mobilization

Intervention Type: 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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hung-Jui Chuang, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 38778416 (View on PubMed)

Other Identifiers

202012084RIN

Identifier Type: -

Identifier Source: org_study_id