Brain InjuriesNCT02924649
Early Mobilisation After Severe Traumatic Brain Injury
A study testing Early Intensive mobilisation in people with Brain Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Early Intensive mobilisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2017to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unstable fractures contraindicating mobilisation.
- Known heart disease or liver cirrhosis prior to brain injury.
- Spinal cord injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Mobilisation by Head-up Tilt With Stepping Compared With Standard Care After Severe Traumatic Brain Injury - a Randomised Clinical Feasibility Trial
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
Read the detailed description
Patients with severe acquired brain injury (ABI) may benefit from early and intensive rehabilitation that in part consists of physical exercise. Studies have found an association between higher-level physical activities and final outcome in patients with ABI. A higher-level activity for patients with severe ABI and disorders of consciousness consists primarily of mobilization to upright standing position on a tilt-table. Intense higher level activities of severe ABI patients are usually not initiated in the acute stage after injury but rather at a later, sub acute stage (weeks), when the patients have been stabilized and transferred to a highly specialized rehabilitation unit. Andelic et al (2012) conducted a non-randomized cohort study where they investigated the effects of early rehabilitation at the intensive care unit. Although the consistency of the rehabilitation paradigm was unspecified, they did observe a benefit of early intervention. A recent randomized pilot study in 31 patients with acute severe ABI and disorders of consciousness concluded that early mobilization using a tilt-table with integrated stepping that increases the venous return of blood to the heart, could be conducted safely, with significant improvements after three months. The hypothesis that early mobilization of patients with severe traumatic brain injury leads to better functional outcome at discharge from the rehabilitation unit and at one year post injury compared to patients that receive usual care needs to be tested in a larger clinical trial.
In parallel, the physiological changes the patients experience due to their injury and the wast amount of bed rest and the possible association with the patients' clinical outcome are explored. Training is often limited by orthostatic intolerance. The physiological mechanisms causing orthostatic hypotension and their recovery have not been thoroughly investigated. In other patient populations with neurally mediated syncope or orthostatic hypotension, intensive tilt-table training has been shown to be beneficial. In addition, recent studies including a large number of ABI patients have found an association between impaired cerebral autoregulation measured the first days after injury and an unfavorable outcome.
Therefore, we wish to assess the feasibility of an early head-up tilt protocol in patients with severe TBI, not only in terms of the number of patients that are successfully mobilised, but also of the number of adverse events and reactions. In exploratory analyses, we will assess physiological outcomes within the first four weeks and clinical outcomes at three months and one year.
The intervention group receives an early and intensive mobilization programme with head-up tilt, during their stay in the intensive care unit and throughout the early stages of rehabilitation. Mobilization will be conducted using a tilt-table with integrated stepping (The ERIGO® from HOCOMA company in Switzerland). The programme will be conducted as a supplement to the patient's usual care.The tilt-table intervention is applied five times per week for a maximum of four weeks during the stay in the neurointensive care unit. Each session consists of 20 min. mobilization. Within each session the patient will be moved to the tilt-table and secured with straps and harness. The patient is then mobilized step wise to 30°, 50° and 70° head-up tilt in one min. intervals while blood pressure, heart rate, and respiratory rate are closely monitored. Cerebral perfusion pressure and intracranial pressure are monitored if relevant. If at any time the predetermined safety limits for blood pressure, cerebral perfusion pressure, intracranial pressure or heart rate are violated, the patient is lowered to 0° tilt (supine position). This procedure is continued until the patient has been tilted upright for a maximum of 20 min. or until a total duration of 40 min. for the head-up tilt procedure has been reached.
If the patient is discharged from the intensive care unit before four weeks, training will continue at the department of neurorehabilitation with a pre-specified tilt-table protocol consisting of mobilization twice a day on a similar tilt-table. Occasionally patients will be transferred to an intensive care unit at another hospital, while waiting for a further training at the department of neurorehabilitation. These patient will continue their mobilization programme on a regular tilt-table without active stepping. Patients who show functional improvement beyond the scope of tilt-table training (e.g. are able to stand from a chair) before the study period has ended, will have their final evaluation performed immediately hereafter and subsequently the standard rehabilitation regimen will be continued.
The control group receives standard care consisting of interdisciplinary rehabilitation. A very small part of the standard care consists of mobilizing the patient to the edge of the bed or to a wheelchair.
At inclusion the patients will be randomized to either group through an open ended blinded randomization procedure, with stratification according to the patients Glasgow Coma Score at the time (3-6 or 7-10). The randomization will consist of blocks of random sizes.
Assuming that the normality assumption is not violated the functional scores and the physiological data will be analysed with analysis of variance (ANOVA) or other linear regression models that takes into account more than two measures over time. Between-group analysis of demographic data will be performed using Student's t test with unequal variance for analysis of two groups or the chi-square test for nominal data.
- Conditions
- Brain Injuries
- Being tested
- Early Intensive mobilisation
- Keywords
- Brain injury, Early mobilisation, Consciousness, Cerebral blood flow, Blood pressure
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Intensive mobilisationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Early Intensive mobilisation |
| Standard care group | No intervention | The standard care group will receive daily mobilisation to the seated position. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within the first four weeks of the study (during the intervention period)
Secondary outcomes (6)
Coma Recovery Scale - Revised (CRS-R)
Measured: Measured at inclusion, after four weeks, three months and at one year follow-up
Early Functional Ability (EFA)
The Early Functional ability scale measures the gap between FIM and the Glasgow Coma Score.
Measured: Measured at inclusion, after four weeks, three months and at one year follow-up
Functional Independence Measures (FIM)
Measured: Measured at inclusion, after four weeks, three months and at one year follow-up
Autoregulation of cerebral blood flow
Using Transcranial Doppler and mean arterial pressure two express cerebral autoregulation during mobilisation to standing position. At these points we will measure carbon dioxide partial pressure and heart rate.
Measured: At baseline, after two weeks and at four weeks
Time with post-traumatic amnesia (PTA)
The neuro psychologists at the departments are assessing this point on a regular basis
Measured: Duration of posttraumatic amnesia
Length of stay at the Neurointensive Care Unit and the Rehabilitation department
Length of stay measured in days
Measured: Duration of length of stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2019
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Principal investigator, Kirsten Moller, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kirsten Møller, Professor, Study director, Rigshospitalet, Dept. of anaesthesiology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924649
- Sponsor's protocol ID
- H-16030775
- Status last verified
- May 2019
- First submitted
- 3 Oct 2016
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Horn SD, DeJong G, Smout RJ, Gassaway J, James R, Conroy B. Stroke rehabilitation patients, practice, and outcomes: is earlier and more aggressive therapy better? Arch Phys Med Rehabil. 2005 Dec;86(12 Suppl 2):S101-S114. doi: 10.1016/j.apmr.2005.09.016.
PubMed 16373145DeJong G, Hsieh CH, Putman K, Smout RJ, Horn SD, Tian W. Physical therapy activities in stroke, knee arthroplasty, and traumatic brain injury rehabilitation: their variation, similarities, and association with functional outcomes. Phys Ther. 2011 Dec;91(12):1826-37. doi: 10.2522/ptj.20100424. Epub 2011 Oct 14.
PubMed 22003165Riberholt CG, Thorlund JB, Mehlsen J, Nordenbo AM. Patients with severe acquired brain injury show increased arousal in tilt-table training. Dan Med J. 2013 Dec;60(12):A4739.
PubMed 24355448Wilson BA DS, Tunnard C, Watson P and Florschutz G. The Effect of Positioning on the Level of Arousal and Awareness in Patients in the Vegetative State or the Minimally Conscious State: A Replication and Extension of a Previous Finding. BRAIN IMPAIRMENT. 2013;14(3):475-9.
Elliott L, Coleman M, Shiel A, Wilson BA, Badwan D, Menon D, Pickard J. Effect of posture on levels of arousal and awareness in vegetative and minimally conscious state patients: a preliminary investigation. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):298-9. doi: 10.1136/jnnp.2004.047357. No abstract available.
PubMed 15654064Newman M, Barker K. The effect of supported standing in adults with upper motor neurone disorders: a systematic review. Clin Rehabil. 2012 Dec;26(12):1059-77. doi: 10.1177/0269215512443373. Epub 2012 May 29.
PubMed 22643724Andelic N, Bautz-Holter E, Ronning P, Olafsen K, Sigurdardottir S, Schanke AK, Sveen U, Tornas S, Sandhaug M, Roe C. Does an early onset and continuous chain of rehabilitation improve the long-term functional outcome of patients with severe traumatic brain injury? J Neurotrauma. 2012 Jan 1;29(1):66-74. doi: 10.1089/neu.2011.1811. Epub 2011 Dec 5.
PubMed 21864138Frazzitta G, Valsecchi R, Zivi I, Sebastianelli L, Bonini S, Zarucchi A, Matteri D, Molatore K, Maestri R, Saltuari L. Safety and Feasibility of a Very Early Verticalization in Patients With Severe Traumatic Brain Injury. J Head Trauma Rehabil. 2015 Jul-Aug;30(4):290-2. doi: 10.1097/HTR.0000000000000135. No abstract available.
PubMed 26147317Riberholt CG, Olesen ND, Thing M, Juhl CB, Mehlsen J, Petersen TH. Impaired Cerebral Autoregulation during Head Up Tilt in Patients with Severe Brain Injury. PLoS One. 2016 May 11;11(5):e0154831. doi: 10.1371/journal.pone.0154831. eCollection 2016.
PubMed 27168188Verheyden B, Ector H, Aubert AE, Reybrouck T. Tilt training increases the vasoconstrictor reserve in patients with neurally mediated syncope evoked by head-up tilt testing. Eur Heart J. 2008 Jun;29(12):1523-30. doi: 10.1093/eurheartj/ehn134. Epub 2008 Mar 27.
PubMed 18375398Lang EW, Lagopoulos J, Griffith J, Yip K, Mudaliar Y, Mehdorn HM, Dorsch NW. Noninvasive cerebrovascular autoregulation assessment in traumatic brain injury: validation and utility. J Neurotrauma. 2003 Jan;20(1):69-75. doi: 10.1089/08977150360517191.
PubMed 12614589Liu X, Czosnyka M, Donnelly J, Budohoski KP, Varsos GV, Nasr N, Brady KM, Reinhard M, Hutchinson PJ, Smielewski P. Comparison of frequency and time domain methods of assessment of cerebral autoregulation in traumatic brain injury. J Cereb Blood Flow Metab. 2015 Feb;35(2):248-56. doi: 10.1038/jcbfm.2014.192. Epub 2014 Nov 19.
PubMed 25407266Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.
PubMed 15605342Hankemeier 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.
PubMed 26482349van Baalen B, Odding E, van Woensel MP, Roebroeck ME. Reliability and sensitivity to change of measurement instruments used in a traumatic brain injury population. Clin Rehabil. 2006 Aug;20(8):686-700. doi: 10.1191/0269215506cre982oa.
PubMed 16944826
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilisation by Head-up Tilt With Stepping Compared With Standard Care After Severe Traumatic Brain Injury - a Randomised Clinical Feasibility Trial
- ClinicalTrials.gov ID
- NCT02924649
- Acronym / sponsor ID
- H-16030775
- Conditions
- Brain Injuries
- Keywords
- Brain injury, Early mobilisation, Consciousness, Cerebral blood flow, Blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2020 (estimated)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Patients with severe acquired brain injury (ABI) may benefit from early and intensive rehabilitation that in part consists of physical exercise. Studies have found an association between higher-level physical activities and final outcome in patients with ABI. A higher-level activity for patients with severe ABI and disorders of consciousness consists primarily of mobilization to upright standing position on a tilt-table. Intense higher level activities of severe ABI patients are usually not initiated in the acute stage after injury but rather at a later, sub acute stage (weeks), when the patients have been stabilized and transferred to a highly specialized rehabilitation unit. Andelic et al (2012) conducted a non-randomized cohort study where they investigated the effects of early rehabilitation at the intensive care unit. Although the consistency of the rehabilitation paradigm was unspecified, they did observe a benefit of early intervention. A recent randomized pilot study in 31 patients with acute severe ABI and disorders of consciousness concluded that early mobilization using a tilt-table with integrated stepping that increases the venous return of blood to the heart, could be conducted safely, with significant improvements after three months. The hypothesis that early mobilization of patients with severe traumatic brain injury leads to better functional outcome at discharge from the rehabilitation unit and at one year post injury compared to patients that receive usual care needs to be tested in a larger clinical trial.
In parallel, the physiological changes the patients experience due to their injury and the wast amount of bed rest and the possible association with the patients' clinical outcome are explored. Training is often limited by orthostatic intolerance. The physiological mechanisms causing orthostatic hypotension and their recovery have not been thoroughly investigated. In other patient populations with neurally mediated syncope or orthostatic hypotension, intensive tilt-table training has been shown to be beneficial. In addition, recent studies including a large number of ABI patients have found an association between impaired cerebral autoregulation measured the first days after injury and an unfavorable outcome.
Therefore, we wish to assess the feasibility of an early head-up tilt protocol in patients with severe TBI, not only in terms of the number of patients that are successfully mobilised, but also of the number of adverse events and reactions. In exploratory analyses, we will assess physiological outcomes within the first four weeks and clinical outcomes at three months and one year.
The intervention group receives an early and intensive mobilization programme with head-up tilt, during their stay in the intensive care unit and throughout the early stages of rehabilitation. Mobilization will be conducted using a tilt-table with integrated stepping (The ERIGO® from HOCOMA company in Switzerland). The programme will be conducted as a supplement to the patient's usual care.The tilt-table intervention is applied five times per week for a maximum of four weeks during the stay in the neurointensive care unit. Each session consists of 20 min. mobilization. Within each session the patient will be moved to the tilt-table and secured with straps and harness. The patient is then mobilized step wise to 30°, 50° and 70° head-up tilt in one min. intervals while blood pressure, heart rate, and respiratory rate are closely monitored. Cerebral perfusion pressure and intracranial pressure are monitored if relevant. If at any time the predetermined safety limits for blood pressure, cerebral perfusion pressure, intracranial pressure or heart rate are violated, the patient is lowered to 0° tilt (supine position). This procedure is continued until the patient has been tilted upright for a maximum of 20 min. or until a total duration of 40 min. for the head-up tilt procedure has been reached.
If the patient is discharged from the intensive care unit before four weeks, training will continue at the department of neurorehabilitation with a pre-specified tilt-table protocol consisting of mobilization twice a day on a similar tilt-table. Occasionally patients will be transferred to an intensive care unit at another hospital, while waiting for a further training at the department of neurorehabilitation. These patient will continue their mobilization programme on a regular tilt-table without active stepping. Patients who show functional improvement beyond the scope of tilt-table training (e.g. are able to stand from a chair) before the study period has ended, will have their final evaluation performed immediately hereafter and subsequently the standard rehabilitation regimen will be continued.
The control group receives standard care consisting of interdisciplinary rehabilitation. A very small part of the standard care consists of mobilizing the patient to the edge of the bed or to a wheelchair.
At inclusion the patients will be randomized to either group through an open ended blinded randomization procedure, with stratification according to the patients Glasgow Coma Score at the time (3-6 or 7-10). The randomization will consist of blocks of random sizes.
Assuming that the normality assumption is not violated the functional scores and the physiological data will be analysed with analysis of variance (ANOVA) or other linear regression models that takes into account more than two measures over time. Between-group analysis of demographic data will be performed using Student's t test with unequal variance for analysis of two groups or the chi-square test for nominal data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intensive mobilisation | Experimental | Procedure: Early Intensive mobilisationAs 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. |
| Standard care group | No intervention | –The standard care group will receive daily mobilisation to the seated position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unstable fractures contraindicating mobilisation.
- Known heart disease or liver cirrhosis prior to brain injury.
- Spinal cord injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Intensive mobilisationThe 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. | Procedure or surgery | Early Intensive mobilisation |
Primary outcome
Feasibility outcome
Time frame: Within the first four weeks of the study (during the intervention period)
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
6 secondary outcomes
Coma Recovery Scale - Revised (CRS-R)
Time frame: Measured at inclusion, after four weeks, three months and at one year follow-up
Early Functional Ability (EFA)
Time frame: Measured at inclusion, after four weeks, three months and at one year follow-up
Functional Independence Measures (FIM)
Time frame: Measured at inclusion, after four weeks, three months and at one year follow-up
Autoregulation of cerebral blood flow
Time frame: At baseline, after two weeks and at four weeks
Time with post-traumatic amnesia (PTA)
Time frame: Duration of posttraumatic amnesia
Length of stay at the Neurointensive Care Unit and the Rehabilitation department
Time frame: Duration of length of stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Background: PubMed 16373145Horn SD, DeJong G, Smout RJ, Gassaway J, James R, Conroy B. Stroke rehabilitation patients, practice, and outcomes: is earlier and more aggressive therapy better? Arch Phys Med Rehabil. 2005 Dec;86(12 Suppl 2):S101-S114. doi: 10.1016/j.apmr.2005.09.016.
- Background: PubMed 22003165DeJong G, Hsieh CH, Putman K, Smout RJ, Horn SD, Tian W. Physical therapy activities in stroke, knee arthroplasty, and traumatic brain injury rehabilitation: their variation, similarities, and association with functional outcomes. Phys Ther. 2011 Dec;91(12):1826-37. doi: 10.2522/ptj.20100424. Epub 2011 Oct 14.
- Background: PubMed 24355448Riberholt CG, Thorlund JB, Mehlsen J, Nordenbo AM. Patients with severe acquired brain injury show increased arousal in tilt-table training. Dan Med J. 2013 Dec;60(12):A4739.
- BackgroundWilson BA DS, Tunnard C, Watson P and Florschutz G. The Effect of Positioning on the Level of Arousal and Awareness in Patients in the Vegetative State or the Minimally Conscious State: A Replication and Extension of a Previous Finding. BRAIN IMPAIRMENT. 2013;14(3):475-9.
- Background: PubMed 15654064Elliott L, Coleman M, Shiel A, Wilson BA, Badwan D, Menon D, Pickard J. Effect of posture on levels of arousal and awareness in vegetative and minimally conscious state patients: a preliminary investigation. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):298-9. doi: 10.1136/jnnp.2004.047357. No abstract available.
- Background: PubMed 22643724Newman M, Barker K. The effect of supported standing in adults with upper motor neurone disorders: a systematic review. Clin Rehabil. 2012 Dec;26(12):1059-77. doi: 10.1177/0269215512443373. Epub 2012 May 29.
- Background: PubMed 21864138Andelic N, Bautz-Holter E, Ronning P, Olafsen K, Sigurdardottir S, Schanke AK, Sveen U, Tornas S, Sandhaug M, Roe C. Does an early onset and continuous chain of rehabilitation improve the long-term functional outcome of patients with severe traumatic brain injury? J Neurotrauma. 2012 Jan 1;29(1):66-74. doi: 10.1089/neu.2011.1811. Epub 2011 Dec 5.
- Background: PubMed 26147317Frazzitta G, Valsecchi R, Zivi I, Sebastianelli L, Bonini S, Zarucchi A, Matteri D, Molatore K, Maestri R, Saltuari L. Safety and Feasibility of a Very Early Verticalization in Patients With Severe Traumatic Brain Injury. J Head Trauma Rehabil. 2015 Jul-Aug;30(4):290-2. doi: 10.1097/HTR.0000000000000135. No abstract available.
- Background: PubMed 27168188Riberholt CG, Olesen ND, Thing M, Juhl CB, Mehlsen J, Petersen TH. Impaired Cerebral Autoregulation during Head Up Tilt in Patients with Severe Brain Injury. PLoS One. 2016 May 11;11(5):e0154831. doi: 10.1371/journal.pone.0154831. eCollection 2016.
- Background: PubMed 18375398Verheyden B, Ector H, Aubert AE, Reybrouck T. Tilt training increases the vasoconstrictor reserve in patients with neurally mediated syncope evoked by head-up tilt testing. Eur Heart J. 2008 Jun;29(12):1523-30. doi: 10.1093/eurheartj/ehn134. Epub 2008 Mar 27.
- Background: PubMed 12614589Lang EW, Lagopoulos J, Griffith J, Yip K, Mudaliar Y, Mehdorn HM, Dorsch NW. Noninvasive cerebrovascular autoregulation assessment in traumatic brain injury: validation and utility. J Neurotrauma. 2003 Jan;20(1):69-75. doi: 10.1089/08977150360517191.
- Background: PubMed 25407266Liu X, Czosnyka M, Donnelly J, Budohoski KP, Varsos GV, Nasr N, Brady KM, Reinhard M, Hutchinson PJ, Smielewski P. Comparison of frequency and time domain methods of assessment of cerebral autoregulation in traumatic brain injury. J Cereb Blood Flow Metab. 2015 Feb;35(2):248-56. doi: 10.1038/jcbfm.2014.192. Epub 2014 Nov 19.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Møller, Professor study director
Rigshospitalet, Dept. of anaesthesiology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Intensive mobilisation in people with Brain Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcome (time frame: Within the first four weeks of the study (during the intervention period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02924649, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.