Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469983
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-14
Brief Title:
Robotic vs Traditional Verticalization in Patients With Severe Acquired Brain Injury a Randomized Controlled Trial
Sponsor:
Anna Estraneo
Organization:
Fondazione Don Carlo Gnocchi Onlus
Study Overview
Official Title:
Multicentric Study on Combined Verticalization and Mobilization in Patients With Severe Acquired Brain Injury A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VEM-sABI
Brief Summary:
In the rehabilitation project for patients with severe Acquired Brain Injury sABI it is essential to include exercises that facilitate the recovery of the upright position or verticalization Recently tilt-table equipped with the robot-assisted lower limbs cyclic mobilization has been proposed as a safe and suitable device for accelerating the adaptation to vertical posture in bedridden patients with brain-injury since the acute phase The present multicentre study aims at evaluating the effectiveness of robotic assisted verticalization RV versus traditional verticalization TV in a large cohort of patients with sABI
Detailed Description:
Background Italian Consensus on rehabilitation of patients with severe acquired brain injury sABI and recent American Academy of Neurology guidelines on patients with sABI and prolonged disorder of consciousness pDoC provided recommendations for admission of such complex disabled patients to inpatient specialized rehabilitation units with high expertise on multidisciplinary care
In such dedicated settings in Italy named as high specialty rehabilitation for sABI Cod 75 a comprehensive standard rehabilitation programme includes positioning prolonged passive range of motion exercises and splinting protocols to prevent or remediate neuromuscular complications contractures spasticity and heterotopic ossifications Simultaneously basic multi-sensory stimulation or targeted cognitive training should be implemented for facilitating cognitive functioning recovery In the rehabilitation project for patients with sABI it is essential to include exercises that facilitate the recovery of the upright position or verticalization in order to prevent secondary complications from immobility eg stasis pneumonias deep vein thrombosis to facilitate the stabilization of the haemodynamic balance known to be altered in this population after the acute event to promote the improvement of cognitive performance especially vigilance and attention and to improve the muscular-cutaneous trophism Verticalization with traditional tilt-table training can show several adverse events no leg movements during tilt-table verticalization lead to limited musculoskeletal and cardiovascular response 2 pooling of blood in the lower extremities which can lead to a drop of the central blood and hypotension 3 It requires substantial modification of cardiovascular therapy due to presyncope symptoms
More recently tilt-table equipped with the robot-assisted lower limbs cyclic mobilization has been proposed as a safe and suitable device for accelerating the adaptation to vertical posture in bedridden patients with brain-injury since the acute phase However contrasting and inconclusive effects of controlled verticalization on functionality gaitbalance and level of consciousness in patients with sABI have been found likely because of the limited methodological quality of the available clinical trials All studies present some concerns such as small cohorts or heterogeneous cohorts of patients with sABI eg chronic patients with sequelae of sABI or the randomization process is not described
The present multicentre study aims at overcoming these limitations evaluating the effectiveness of robotic assisted verticalization versus traditional verticalization TV in a large cohort of patients with sABI Standardized and validated clinical tools will be used for evaluating effect on patients motor cognitive and functional performances Additional markers will be used as outcome measures for investigating possible brain plasticity Neurophysiological findings eg EEG background activity and reactivity and quantitative EEG metrics and blood biomarkers have been correlated to cognitive performance and assist prognostication in patients with sABI and pDoC34 Brain-derived neurotrophic factor BDNF a neurotrophin involved in neurogenesis and synaptic plasticity can be upregulated by physical exercise However a recent study showed that BDNF serum levels do not change after robotic assisted verticalization in patients with pDoC Neurofilament light chain NF-L a marker of primary and secondary neurodegeneration in sABI was linked to long-term axonal degeneration and poor outcome Glial fibrillary acid protein GFAP a filament protein is related to brain function recovery
Methods 198 patients will be randomized to receive either RV or TV at the same period of the day throughout the experiment In the week before starting study protocol the RV and TV groups will undergo a preliminary tolerance session test of gradual verticalization starting from 10 min and then progression toward 30 min
The study protocol will involve 5 RV or 5 TV sessions per week for 4 weeks total 20 sessions Each daily RV or SR session last 30 minutes
RV protocol and parameters Erigo gradual verticalization from supine position up to maximum 90 in 3 steps depending on the patients vital signs compliance The Erigo verticalization is coupled with the rhythmic passive movement of the lower limbs ensuring the more normal range of motion ROM and the alternation of loading and unloading of the lower limbs based on patients osteo-articular condition eg ROM45 cadencemin 24 steps per minute
TV protocol consists in gradual verticalization from supine position up to maximum 90 in 3 steps depending on the patients vital signs compliance using a traditional standing device ie non-robotic traditional tilt table Both groups received an additional 60 minute-comprehensive daily 60 minutes rehabilitation programme in the 3 months of the study This programme consists of alternate bed positioning passive limbs mobilization activities to increase arousal eg multisensory stimulation language and swallowing therapy based on patients functional condition
Primary endpoint Coma Recovery-Scale Revised CRS-R pDoC and Level of Cognitive Functioning LCF EpDoC Secondary endpoints Modified Ashworth scale MAS Muscle Research Council MRC EpDoC pDoC reflex movement to nociceptive stimulation pDoC Disability Rating Scale DRS Adverse Events Report AERAgitation Behavior Scale and Nociception Coma Scale respectively System Usability Scale SUS modified Barthel Index mBI
Exploratory endpoints EEG architecture eg microstates functional connectivity and complexity measures Blood biomarkers ie BDNF NF-L and GFAP Fondazione Don Gnocchi-Clinical Complications Scale FDG-CCS
Adverse Events Report weekly from enrolment through termination of RV or TV protocol During VEM session Heart rate HR mean arterial pressure MAP oxygen saturation SaO2 agitation and pain will be monitored Additionally agitation and pain will be measured by the Agitation Behavior Scale and Nociception Coma Scale respectively
In such dedicated settings in Italy named as high specialty rehabilitation for sABI Cod 75 a comprehensive standard rehabilitation programme includes positioning prolonged passive range of motion exercises and splinting protocols to prevent or remediate neuromuscular complications contractures spasticity and heterotopic ossifications Simultaneously basic multi-sensory stimulation or targeted cognitive training should be implemented for facilitating cognitive functioning recovery In the rehabilitation project for patients with sABI it is essential to include exercises that facilitate the recovery of the upright position or verticalization in order to prevent secondary complications from immobility eg stasis pneumonias deep vein thrombosis to facilitate the stabilization of the haemodynamic balance known to be altered in this population after the acute event to promote the improvement of cognitive performance especially vigilance and attention and to improve the muscular-cutaneous trophism Verticalization with traditional tilt-table training can show several adverse events no leg movements during tilt-table verticalization lead to limited musculoskeletal and cardiovascular response 2 pooling of blood in the lower extremities which can lead to a drop of the central blood and hypotension 3 It requires substantial modification of cardiovascular therapy due to presyncope symptoms
More recently tilt-table equipped with the robot-assisted lower limbs cyclic mobilization has been proposed as a safe and suitable device for accelerating the adaptation to vertical posture in bedridden patients with brain-injury since the acute phase However contrasting and inconclusive effects of controlled verticalization on functionality gaitbalance and level of consciousness in patients with sABI have been found likely because of the limited methodological quality of the available clinical trials All studies present some concerns such as small cohorts or heterogeneous cohorts of patients with sABI eg chronic patients with sequelae of sABI or the randomization process is not described
The present multicentre study aims at overcoming these limitations evaluating the effectiveness of robotic assisted verticalization versus traditional verticalization TV in a large cohort of patients with sABI Standardized and validated clinical tools will be used for evaluating effect on patients motor cognitive and functional performances Additional markers will be used as outcome measures for investigating possible brain plasticity Neurophysiological findings eg EEG background activity and reactivity and quantitative EEG metrics and blood biomarkers have been correlated to cognitive performance and assist prognostication in patients with sABI and pDoC34 Brain-derived neurotrophic factor BDNF a neurotrophin involved in neurogenesis and synaptic plasticity can be upregulated by physical exercise However a recent study showed that BDNF serum levels do not change after robotic assisted verticalization in patients with pDoC Neurofilament light chain NF-L a marker of primary and secondary neurodegeneration in sABI was linked to long-term axonal degeneration and poor outcome Glial fibrillary acid protein GFAP a filament protein is related to brain function recovery
Methods 198 patients will be randomized to receive either RV or TV at the same period of the day throughout the experiment In the week before starting study protocol the RV and TV groups will undergo a preliminary tolerance session test of gradual verticalization starting from 10 min and then progression toward 30 min
The study protocol will involve 5 RV or 5 TV sessions per week for 4 weeks total 20 sessions Each daily RV or SR session last 30 minutes
RV protocol and parameters Erigo gradual verticalization from supine position up to maximum 90 in 3 steps depending on the patients vital signs compliance The Erigo verticalization is coupled with the rhythmic passive movement of the lower limbs ensuring the more normal range of motion ROM and the alternation of loading and unloading of the lower limbs based on patients osteo-articular condition eg ROM45 cadencemin 24 steps per minute
TV protocol consists in gradual verticalization from supine position up to maximum 90 in 3 steps depending on the patients vital signs compliance using a traditional standing device ie non-robotic traditional tilt table Both groups received an additional 60 minute-comprehensive daily 60 minutes rehabilitation programme in the 3 months of the study This programme consists of alternate bed positioning passive limbs mobilization activities to increase arousal eg multisensory stimulation language and swallowing therapy based on patients functional condition
Primary endpoint Coma Recovery-Scale Revised CRS-R pDoC and Level of Cognitive Functioning LCF EpDoC Secondary endpoints Modified Ashworth scale MAS Muscle Research Council MRC EpDoC pDoC reflex movement to nociceptive stimulation pDoC Disability Rating Scale DRS Adverse Events Report AERAgitation Behavior Scale and Nociception Coma Scale respectively System Usability Scale SUS modified Barthel Index mBI
Exploratory endpoints EEG architecture eg microstates functional connectivity and complexity measures Blood biomarkers ie BDNF NF-L and GFAP Fondazione Don Gnocchi-Clinical Complications Scale FDG-CCS
Adverse Events Report weekly from enrolment through termination of RV or TV protocol During VEM session Heart rate HR mean arterial pressure MAP oxygen saturation SaO2 agitation and pain will be monitored Additionally agitation and pain will be measured by the Agitation Behavior Scale and Nociception Coma Scale respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None