Projects

Rehabilitation Bioengineering

Projects - -

Research in the field of bioengineering applications to rehabilitation is mainly carried out in collaboration with the Department of Biorobotics of the Sant’Anna High School in Pisa, and has availed itself of the presence of robotic devices for the rehabilitation of the upper limb and wrist ( InMotion2, InMotion 3, ENGINE), and other devices for neuro-rehabilitation. This activity was accompanied by the study of human-machine interaction during mechanical ventilation, and the development of models for remote monitoring and rehabilitation.

Rehabilitation Bioengineering Laboratory

Title Project Responsible Project Type
The use of a robotic system for the rehabilitation of the upper limb of patients with neurological damage in the sub-acute and chronic phase (InMOTION2) (2754/2009) F. Posteraro
S. Mazzoleni		 Single Center, Spontaneous, Devices / medical devices
Longitudinal clinical study for wrist rehabilitation in hemiparetic patients using a robotic system (InMOTION3) (3919/2013) F. Posteraro/S. Mazzoleni
Single Center Spontaneous		 Devices / medical devices
Controlled randomized sham study for robotic rehabilitation and direct current transcranial stimulation in motor recovery of the upper limb in post-stroke patients in the subacute phase (3918/2014) F. Posteraro/S. Mazzoleni Single Center, Spontaneous, Devices / medical devices
Analysis of the ventilator patient interaction of subjects with difficult weaning from invasive mechanical ventilation (3340/2011) G. Vagheggini/S. Mazzoleni T Single Center, Spontaneous, Devices / medical devices
Use of a robotic system for the rehabilitation of the upper limb of post-stroke patients in the sub-acute and chronic phase (ENGINE) F. Posteraro/S. Mazzoleni Single Center, Spontaneous, Devices / medical devices

Cognitive-psychological studies in collaboration with Auxilium Vitae

Projects - -

Many observational and interventional clinical studies are conducted in the cardiorespiratory and neurological area of Auxilium Vitae, and mainly have as their object the analysis of the various aspects of rehabilitation outcomes, the physiology of exercise and the evaluation of techniques or devices, or particular treatment schemes. Some studies are conducted in the context of multicentric trials, sometimes supported by an unconditional contribution from companies producing electro-medical devices.

These studies represent a current research activity, to which the various professional figures of Auxilium Vitae contribute, which produces an important part of presentations at conferences and scientific publications, in addition to collaborations with important Italian and international rehabilitation centers.

Numerous clinical and pathophysiological studies are carried out in the cognitive-psychological field, with excellent results in particular in the evaluation of the patient with eminegligence and aphasia and in the rehabilitation of the comatose patient following a head injury.

Below there is a review of the current or recently completed cognitive-psychological studies, and some of the most recent and significant ISI publications produced.

Cognitive-psychological studies

Title Project Responsible Project Type
Psychological responses to a cardiological rehabilitation path supplemented by systematic psychological monitoring D. Gaci Scaletti
(Auxilium Vitae)		 Observational
Single Center
Spontaneo
Assessment of the psychological Locus of Control in subjects with COPD undergoing Respiratory Rehabilitation F. Moretti
(Auxilium Vitae)		 Observational
Single Center
Spontaneo
No Profit
Comparison of the Oxford Cognitive Screen and Mini Mental State Examination in the cognitive assessment of individuals with stroke M. Caputo
(Auxilium Vitae)
Promotore: Italian OCS Group		 Multi center
Observational
No Profit
FMRI study of progression from vegetative state to state of minimal consciousness F. Tomaiuolo
(Auxilium Vitae)		 Single Center
Observational
Finanziamento Fondazione CRV

Prognostic value of some neuroradiological indices of brain damage in the results of severe head injury, correlation with the outcome. SIRN 2017 “Dolce” Award”		 M.C. Carboncini
(UNIPI)
F. Tomaiuolo
(Auxilium Vitae)		 Multi center
Observational
No Profit
Diagnosis, prognosis of the rehabilitation treatment of the patient with Eminegligence or Aphasia F. Tomaiuolo
(Auxilium Vitae)		 Single Center
Observational
No Profit
Bibliography COGNITIEVE-PSYCHOLOGICAL STUDIES
  1. Basagni B, Luzzatti C, Navarrete E, Caputo M, Scrocco G, Damora A, Giunchi L, Gemignani P, Caiazzo A, Gambini MG, Avesani R, Mancuso M, Trojano L, De Tanti A. VRT (verbal reasoning test): a new test for assessment of verbal reasoning. Test realization and Italian normative data from a multicentric study. Neurol Sci. 2017 Apr;38(4):643-650. doi: 10.1007/s10072-017-2817-9. Epub 2017 Jan 17.
  2. Mancuso M, Demeyere N, Abbruzzese L,Damora A, Varalta V, Pirrotta F, Antonucci G, Matano A, Caputo M, Caruso MG, PontiggiaGT, Coccia M, Cianciarelli I, Zoccolotti P, and the Italian OCS Group* A comparison of the Oxford Cognitive Screen and Mini Mental State Examination in the cognitive assessment of patients with stroke. European Journal of Neurology, accepted.
  3. Tomaiuolo F, Cecchetti L, Owen AM, Logi F, Malasoma F, Cozza S, Pietrini P, Ricciardi E. Progression from vegetative to minimally conscious state is associated with changes in brain neural response to passive tasks: A longitudinal single-case fMRI study. J Int Neuropsychol Soc. 2016 Jul;22(6):620-30. doi: 10.1017/S1355617716000485.
  4. Thiebaut de Schotten M, Tomaiuolo F, Aiello M, Merola S, Silvetti M, Lecce F, Bartolomeo P, Doricchi F. Damage to white matter pathways in subacute and chronic spatial neglect: a group study and 2 single-case studies with complete virtual “in vivo” tractography dissection. Cereb Cortex. 2014 Mar;24(3):691-706. doi:10.1093/cercor/bhs351. Epub 2012 Nov 15. PubMed PMID: 23162045.
  5. Tomaiuolo F, Bivona U, Lerch JP, Di Paola M, Carlesimo GA, Ciurli P, Matteis M, Cecchetti L, Forcina A, Silvestro D, Azicnuda E, Sabatini U, Di Giacomo D, Caltagirone C, Petrides M, Formisano R. Memory and anatomical change in severe non missile traumatic brain injury: ‚1 vs. 8 years follow-up. Brain Res Bull. 2012 Mar 10;87(4-5):373-82. doi: 10.1016/j.brainresbull.2012.01.008. Epub 2012 Jan 24. PubMed PMID: 22289841.
  6. Mancuso M, Capitani D, Ferroni L, Caputo M, Bartalini B, Abbruzzese L, Pirrotta F, Rossi G, Pacini M, Spaccavento S, Asnicar M, Farinello C, Gemignani P, Cantagallo A. Efficacy of Prisms in Neglect Treatment: A Randomized Single Blind Study Int J Phys Med Rehabil 2016, 4:4 DOI:10.4172/2329-9096.1000355
  7. Cecchetti L, Tomaiuolo F, Ricciardi E. Luci e ombre delle neuroimmagini nella valutazione dei disordini di coscienza. In ‘Il teatro della coscienza: autori, attori, spettatori’, B. Rossi, M. C. Carboncini (Eds.) – Felici Edizioni, Pisa, 2015 – ISBN: 978-88-6940-008-7
  8. Mancuso M, Rosadoni S, Capitani D, Bickerton WL, Humphreys GW, De Tanti A, Zampolini M, Galardi G, Caputo M, De Pellegrin S, Angelini A, Bartalini B, Bartolo M, Carboncini MC, Gemignani P, Spaccavento S, Cantagallo A, Zoccolotti P, Antonucci G.Italian standardization of the Apples Cancellation Test. Neurol Sci. 2015 Jul;36(7):1233-40. doi: 10.1007/s10072-015-2088-2. Epub 2015 Jan 25.
  9. Bonifazi S, Tomaiuolo F, Altoè G, Ceravolo MG, Provinciali L, Marangolo P. Action observation as a useful approach for enhancing recovery of verb production: new evidence from aphasia. Eur J Phys Rehabil Med. 2013 Aug;49(4):473-81. Epub 2013 Mar 13.
  10. Logi F, Pasqualetti P, Tomaiuolo F. Predict recovery of consciousness in post-acute severe brain injury: the role of EEG reactivity. Brain Inj. 2011;25(10):972-9. doi: 10.3109/02699052.2011.589795. Epub 2011 Jul 12. PubMed PMID: 21745174.
  11. Marangolo P, Marinelli CV, Bonifazi S, Fiori V, Ceravolo MG, Provinciali L, Tomaiuolo F. Electrical stimulation over the left inferior frontal gyrus (IFG) determines long-term effects in the recovery of speech apraxia in three chronic aphasics. Behav Brain Res. 2011 Dec 1;225(2):498-504. doi: 10.1016/j.bbr.2011.08.008. Epub 2011 Aug 12. PubMed PMID: 21856336.
  12. Tomaiuolo F, Voci L, Bresci M, Cozza S, Posteraro F, Oliva M, Doricchi F. Selective visual neglect in right brain damaged patients with splenial interhemispheric disconnection. Exp Brain Res. 2010 Oct;206(2):209-17. doi: 10.1007/s00221-010-2230-6. Epub 2010 Apr 6. PubMed PMID: 20369232.

The Bioengineering Laboratory of Rehabilitation

Projects - -

The Rehabilitation Bioengineering Laboratory was established in 2011 thanks to the agreement signed between Auxilium Vitae Volterra S. p.A. and Sant’Anna School of Advanced Studies in Pisa.

The Laboratory is located in the Auxilium Vitae clinical facilities, in dedicated spaces, where the Scuo-la Superiore Sant’Anna has made available its own scientific equipment and its personnel who work in contact with the doctors and professionals of the rehabilitation of Auxilium. Vitae. The close collaboration between bioengineers, doctors and therapists has allowed the development and validation of innovative devices and rehabilitation treatments with the aim of improving the quality of life of patients and ensuring continuity of hospital-territory care.

Today the Laboratory continues its activities under the aegis of the Volterra Ricerche Foundation by taking advantage of a Scientific Committee composed of Prof. Paolo Dario, Director of the Biomedical Institute of the Sant’Anna School of Pisa, by Dr. Guido Vagheggini, Health Director of Auxilium Vitae, Prof. Stefano Mazzoleni, Biorobotics Institute of Sant’Anna School of Advanced Studies, and Prof. Nicolino Ambrosino, Research Consultant in Pneumology.

The research activities of the Bioengineering Laboratory of Rehabilitation are mainly focused on the following topics of scientific and clinical interest:

  1. Robotics for neurological rehabilitation
  2. Telerehabilitation and telemonitoring for respiratory rehabilitation
  3. Telerehabilitation and telemonitoring for cardiological rehabilitation
  4. Telerehabilitation for neurological rehabilitation
  5. Telemonitoring of patients in vegetative state / state of minimum consciousness

REHABILITATION BIOENGINEERING WORKSHOP – Funded projects

“Telerehabilitation” research project
1. Research lines: Neurorological tele-rehabilitation, respiratory tele-rehabilitation, cardiological tele-rehabilitation
2. Partner subject: Scuola Superiore Sant’Anna
3. Financing body: Cassa di Risparmio di Volterra Foundation
4. Period: 2008-2010

Development and application of TECnologies for Televalutation, alternative communication and environmental automation of patients with severe and severe disabilities “(TEC-TUM)
5. Research lines: Neurorological telerehabilitation
6. Proponent subject / coordinator: Scuola Superiore Sant’Anna
7. Partner subjects: Auxilium Vitae Volterra, Humanware Srl
8. Financing Body: Tuscany Region (Call for Young Researchers – P. O.R. Tuscany Regional Competitiveness and Employment 2007-2013)
9. Period: March 2010-February 2013

Telerehabilitation and Robotics
1. Research lines: 1) Robotic and mechatronic systems for neurorehabilitation (upper limb), 2) Cardio – Respiratory and Neuro-motor rehabilitation
2. Proponent subject / coordinator: Auxilium Vitae Volterra
3. Partner subjects: Scuola Superiore Sant’Anna
4. Financing body: Tuscany Region (Regional Research Program on Health 2009), co-funding of the Cassa di Risparmio di Volterra Foundation
5. Period: 2010-2012

Innovative technologies to support the rehabilitation program
1. Research lines: 1) Robotic and mechatronic systems for neuro-rehabilitation (lower limb and upper limb), 2) Cardio-respiratory and neuro-motor rehabilitation, 3) Home automation – ergonomic laboratory
2. Proponent subject / coordinator: Scuola Superiore Sant’Anna
3. Partner subjects: Auxilium Vitae Volterra
4. Financing body: Tuscany Region (Directorate General for Health and Solidarity Policies)
5. Period: 2009-2012

Earlyrehab
1. Proponent subject / coordinator: Scuola Superiore Sant’Anna
2. Partner subjects: Auxilium Vitae Volterra
3. Financing body: Tuscany Region (Program for Regional Research in Health 2009)
4. Period: 2011-2013

Development of a 2nd MObile roboT for NeurO rehabilitation (MOTO)
1. Proponent subject / coordinator: Humanware srl
2. Partner subjects: St. Anna School, Auxilium Vitae Volterra
3. Financing body: Tuscany Region
4. Period: 2010-2011

ASSO – An integrated eHealth environment to support continuity of care, providing complete risk management and patient empowerment
5. Coordinating entity: Dedalus SpA
6. Financing body: Tuscany Region (Single Call POR-CReO 2012 – line B)
7. Period: 2013-2015

COST Action 1006 – European Network on Robotics for NeuroRehabilitation
8. Financing body: EU Framework Program Horizon 2020
9. Period: 2011-2015

Task force “Telemonitoring of ventilator-dependent patients” (TF-2013-10)
10. Financing Body: European Respiratory Society (ERS)
11. Period: 2014-2016

Bibliography CLINICAL REHABILITATION STUDIES
  1. Ambrosino N, Vagheggini G, Mazzoleni S, Vitacca M. Telemedicine in chronic obstructive pulmonary disease. Breathe (Sheff). 2016 Dec;12(4):350-356. doi: 10.1183/20734735.014616.
  2. Ambrosino N, Venturelli E, de Blasio F, Paggiaro P, Pasqua F, Vitacca M, Vagheggini G, Clini EM. A prospective multicentric study of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease and different clinical phenotypes. Respiration. 2015;89(2):141-7. doi: 10.1159/000371471. Epub 2015 Jan 28.
  3. Sanguinetti CM, Ambrosino N, Andò F, De Benedetto F, Donner CF, Nardini S, Polverino M, Torchio R, Vagheggini G, Visconti A; Consensus Conference 2013 Group. Standards of suitability for the management of chronic obstructive respiratory diseases. Multidiscip Respir Med. 2014 Dec 18;9(1):65. doi: 10.1186/2049-6958-9-65. eCollection 2014.
  4. Vagheggini G, Vlad EP, Mazzoleni S, Bortolotti U, Guarracino F, Ambrosino N. Outcomes for difficult-to-wean subjects after cardiac surgery. Respir Care. 2015 Jan;60(1):56-62. doi: 10.4187/respcare.03315. Epub 2014 Oct 21.
  5. Di Paco A, Catapano GA, Vagheggini G, Mazzoleni S, Micheli ML, Ambrosino N. Ventilatory response to exercise of elite soccer players. Multidiscip Respir Med. 2014 Apr 2;9(1):20. doi: 10.1186/2049-6958-9-20.
  6. Venturelli E, Crisafulli E, DeBiase A, Righi D, Berrighi D, Cavicchioli PP, Vagheggini G, Dabrosca F, Balbi B, Paneroni M, Bianchi L, Vitacca M, Galimberti V, Zaurino M, Schiavoni G, Iattoni A, Ambrosino N, Clini EM. Efficacy of temporary positive expiratory pressure (TPEP) in patients with lung diseases and chronic mucus hypersecretion. The UNIKO® project: a multicentre randomized controlled trial. Clin Rehabil. 2013 Apr;27(4):336-46. doi: 10.1177/0269215512458940. Epub 2012 Sep 11.
  7. Ambrosino N, Venturelli E, Vagheggini G, Clini E. Rehabilitation, weaning and physical therapy strategies in chronic critically ill patients. Eur Respir J. 2012 Feb;39(2):487-92. doi: 10.1183/09031936.00094411. Epub 2011 Dec 1. Review.
  8. Crisafulli E, Venturelli E, Biscione G, Vagheggini G, Iattoni A, Lucic S, Ambrosino N, Pasqua F, Cesario A, Clini EM. Exercise performance after standard rehabilitation in COPD patients with lung hyperinflation. Intern Emerg Med. 2014 Feb;9(1):23-31. doi: 10.1007/s11739-011-0727-z. Epub 2011 Nov 22.
  9. Ambrosino N, Janah N, Vagheggini G. Physiotherapy in critically ill patients. Rev Port Pneumol. 2011 Nov-Dec;17(6):283-8. doi: 10.1016/j.rppneu.2011.06.004. Epub 2011 Jul 22. Review.
  10. Montagnani G, Vagheggini G, Panait Vlad E, Berrighi D, Pantani L, Ambrosino N. Use of the Functional Independence Measure in people for whom weaning from mechanical ventilation is difficult. Phys Ther. 2011 Jul;91(7):1109-15. doi: 10.2522/ptj.20100369. Epub 2011 May 19.
  11. Carpenè N, Vagheggini G, Panait E, Gabbrielli L, Ambrosino N. A proposal of a new model for long-term weaning: respiratory intensive care unit and weaning center. Respir Med. 2010 Oct;104(10):1505-11. doi: 10.1016/j.rmed.2010.05.012. Epub 2010 Jun 11.

Clinical-rehabilitative studies in collaboration with Auxilium

Projects - -

Many observational and interventional clinical studies are conducted in the cardiorespiratory and neurological areas of Auxilium Vitae, and mainly have as their object the analysis of the various aspects of rehabilitation outcomes, the physiology of exercise and the evaluation of techniques or devices, or particular treatment schemes. Some studies are conducted in the context of multicentric trials, sometimes supported by an unconditional contribution from companies producing electro-medical devices.

These studies represent a current research activity, to which the various professional figures of Auxilium Vitae contribute, which produces an important part of presentations at conferences and scientific publications, in addition to collaborations with important Italian and international rehabilitation centers.

Numerous clinical and pathophysiological studies are carried out in the cognitive-psychological field, with excellent results in particular in the evaluation of the patient with eminegligence and aphasia and in the rehabilitation of the comatose patient following a head injury.
Below there is a review of the current or recently completed cognitive-psychological studies, and some of the most recent and significant ISI publications produced.

Clinical-rehabilitative studies

Title Project Responsible Project Type
Randomized controlled clinical feasibility study of a respiratory rehabilitation program in patients with chronic respiratory disease following acute exacerbations (3472/2011) G. Vagheggini (Auxilium Vitae) Single Center, Spontaneous
Evaluation of the additional effect of non-invasive mechanical ventilation (VMN) during exercise in a cycle ergometer training program in patients with chronic respiratory failure in home nocturnal VMNI (667 / 2011CEC FSM) K. Foglio (FSM Lumezzane)
G. Vagheggini (Auxilium Vitae)		 Multi center, Spontaneous, No Profit
Evaluation of swallowing disorders in subjects with difficulty weaning from mechanical ventilation A. Bartolini
M. Bilei (Auxilium Vitae)		 Single Center, Observational, Spontaneous
Use of binaural beats as non-pharmacological premedication in elderly subjects to be subjected to major orthopedic surgery. Randomized controlled trial (NCT02712749) A. Tani (Anestesia e Rianimazione AVC)
F. Moretti (Auxilium Vitae) F. Tomaiuolo (Auxilium Vitae) G. Vagheggini (Auxilium V.)		 Controlled randomized trial, Single Center, Spontaneous
Bibliography CLINICAL-REHABILITATIVE STUDIES
  1. Ambrosino N, Vitacca M, Dreher M, Isetta V, Montserrat JM, Tonia T, Turchetti G, Winck JC, Burgos F, Kampelmacher M, Vagheggini G; ERS Tele-Monitoring of Ventilator-Dependent Patients Task Force. Tele-monitoring of ventilator-dependent patients: a European Respiratory Society Statement. Eur Respir J. 2016 Sep;48(3):648-63. doi: 10.1183/13993003.01721-2015. Epub 2016 Jul 7.
  2. Mazzoleni S, Montagnani G, Vagheggini G, Buono L, Moretti F, Dario P, Ambrosino N. Interactive videogame as rehabilitation tool of patients with chronic respiratory diseases: preliminary results of a feasibility study. Respir Med. 2014 Oct;108(10):1516-24. doi: 10.1016/j.rmed.2014.07.004. Epub 2014 Jul 16.
  3. Vagheggini G, Mazzoleni S, Vlad Panait E, Navalesi P, Ambrosino N. Physiologic response to various levels of pressure support and NAVA in prolonged weaning. Respir Med. 2013 Nov;107(11):1748-54. doi: 10.1016/j.rmed.2013.08.013. Epub 2013 Aug 30.

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