Early Mobilisation After Severe Traumatic Brain Injury

NCT02924649 | Unknown DMC

• 1 other identifier: H-16030775
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Increasing focus on the negative effects of bed rest have become more apparent in the intensive care unit within the last decade. A few studies have found an association between early rehabilitation starting at the intensive care unit and outcome after discharge from rehabilitation. The early mobilization presents with challenges regarding haemodynamic stability. The aim of this trial is to assess the feasibility before conducting a larger randomised trial that will investigate benefits and harms of an intensive physical rehabilitation intervention focusing on mobilisation to the upright position, starting as early as clinically feasible in the intensive care unit

Conditions

Brain Injuries

Keywords

Brain injury; Early mobilisation; Consciousness; Cerebral blood flow; Blood pressure

Outcome Measures

Primary Outcomes (1)

• Feasibility outcome

  Successful inclusion of 60% or more of the patients. The intervention will be considered feasible if at least 80% of the intended treatment sessions are applied to at least 70% of the patients. Adverse events and reactions (serious and not serious) and suspected unexpected serious adverse reactions

  Within the first four weeks of the study (during the intervention period)

Secondary Outcomes (6)

• Coma Recovery Scale - Revised (CRS-R)

  Measured at inclusion, after four weeks, three months and at one year follow-up

• Early Functional Ability (EFA)

  Measured at inclusion, after four weeks, three months and at one year follow-up

• Functional Independence Measures (FIM)

  Measured at inclusion, after four weeks, three months and at one year follow-up

• Autoregulation of cerebral blood flow

  At baseline, after two weeks and at four weeks

• Time with post-traumatic amnesia (PTA)

  Duration of posttraumatic amnesia

Study Arms (2)

Early Intensive mobilisation

EXPERIMENTAL

As early as possible the experimental group will receive mobilisation on a tilt table for up to 20 minutes 5 days a week for four weeks using an ERIGO tilt table. If orthostatic hypotension occur the patient is moved to supine until parameters are stable again. Hereafter the mobilisation will continue until the patient has completed 20 minutes of standing exercise.

Procedure: Early Intensive mobilisation

Standard care group

NO INTERVENTION

The standard care group will receive daily mobilisation to the seated position.

Interventions

Early Intensive mobilisation PROCEDURE

The intervention will be performed using a tilt table with integrated stepping movements of the lower extremity (ERIGO, HOCOMA, Switzerland). The goal of the intervention session is that the patient stands upright for 20 minutes. If orthostatic intolerance or increase in intracranial pressure occurs the session will be paused. When the patient is stable mobilization is continued.

Early Intensive mobilisation

Eligibility Criteria

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

You may qualify if:

• Traumatic brain injury (TBI)
• Disorders of consciousness (with a tentative diagnosis of the vegetative or minimally conscious state), with a Glasgow Coma Score \< 10 during wake-up call.
• Stable intracranial pressure (ICP \< 20 mmHg for 24 hours).
• Must be able to mobilise beyond 30 degrees elevation

You may not qualify if:

• Unstable fractures contraindicating mobilisation.
• Known heart disease or liver cirrhosis prior to brain injury.
• Spinal cord injury.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

Rigshospitalet,

Copenhagen, Denmark

Location

Related Publications (23)

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• Hankemeier A, Rollnik JD. The Early Functional Abilities (EFA) scale to assess neurological and neurosurgical early rehabilitation patients. BMC Neurol. 2015 Oct 19;15:207. doi: 10.1186/s12883-015-0469-z.

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• Stubbs PW, Pallesen H, Pedersen AR, Nielsen JF. Using EFA and FIM rating scales could provide a more complete assessment of patients with acquired brain injury. Disabil Rehabil. 2014;36(26):2278-81. doi: 10.3109/09638288.2014.904935. Epub 2014 Mar 28.

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• Riberholt CG, Olsen MH, Berg RMG, Mehlsen J, Moller K. Dynamic cerebral autoregulation during early orthostatic exercise in patients with severe traumatic brain injury: Further exploratory analyses from a randomized clinical feasibility trial. J Clin Neurosci. 2021 Oct;92:39-44. doi: 10.1016/j.jocn.2021.07.047. Epub 2021 Aug 3.

  PMID: 34509259 DERIVED

• Riberholt CG, Olsen MH, Sondergaard CB, Gluud C, Ovesen C, Jakobsen JC, Mehlsen J, Moller K. Early Orthostatic Exercise by Head-Up Tilt With Stepping vs. Standard Care After Severe Traumatic Brain Injury Is Feasible. Front Neurol. 2021 Apr 14;12:626014. doi: 10.3389/fneur.2021.626014. eCollection 2021.

  PMID: 33935935 DERIVED

• Riberholt CG, Lindschou J, Gluud C, Mehlsen J, Moller K. Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury - Protocol for a randomised clinical feasibility trial. Trials. 2018 Nov 8;19(1):612. doi: 10.1186/s13063-018-3004-x.

  PMID: 30409170 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kirsten Møller, Professor

  Rigshospitalet, Dept. of anaesthesiology, Rigshospitalet

  STUDY DIRECTOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

DK (1)