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Service / Methodology Topic Robotic assisted rehabilitation Organisation Department/Unit Don Carlo Gnocchi Foundation (FDG) Innovation and Development Department Title Advanced tools and methods for management, monitoring and optimization of rehabilitation processes Target Group Age Adults affected by neurological diseases (mainly Stroke, Multiple Sclerosis, Parkinson disease, Polyneuropathy) or orthopedic diseases, with involvement of the upper limb. Professionals involved: personnel involved in managing or coordinating rehabilitation processes (medical directors, coordinators of therapists etc.) and personnel involved in monitoring the use of resources and strategic decision making (directors of rehabilitation centres, management controller etc). Description (350 words max) FDG operates a network of 29 rehabilitation centres throughout Italy, overall serving about 9.000 patients daily in hospital, outpatient and home care. Recently, considerable work has been carried out to optimize rehabilitation processes and clinical protocols, in order to uniform them and achieve standardized procedures with objective measurement on their efficacy and efficiency. Within this context, the robotic assisted rehabilitation was first implemented in 2015. Nowadays, nine FDG centres are equipped with robots able to deliver rehabilitation by exercise in augmented reality environment. To account for sustainability, an organizational model was developed that includes a therapist to monitor 1 to 4 patients working on robots within 45 minutes individual sessions. The introduction of this model into clinical practice brought about the need to review the management process. Following a simulation considering the entire process, a scheduling system was developed, able to guarantee the saturation of the robots during each slot of the day by selecting patients at different levels of impairment. Furthermore, a data centralization process was implemented by networking the robots within the Foundation’s IT infrastructure and aggregating their data into a central database.

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Page 1: Service / Methodology · Business intelligence dashboards have been purposely created to offer services to managers, clinicians and researchers. The dashboards allow controlling the

 

Service / Methodology

Topic Robotic assisted rehabilitation 

Organisation Department/Unit

Don Carlo Gnocchi Foundation (FDG) 

Innovation and Development Department 

Title Advanced tools and methods for management, monitoring and optimization of rehabilitation processes 

Target Group Age

Adults affected by neurological diseases (mainly Stroke, Multiple Sclerosis, Parkinson disease, Polyneuropathy) or orthopedic diseases, with involvement of the upper limb. 

Professionals involved: personnel involved in managing or coordinating rehabilitation processes (medical directors, coordinators of therapists etc.) and personnel involved in monitoring the use of resources and strategic decision making (directors of rehabilitation centres, management controller etc). 

Description (350 words max)

FDG operates a network of 29 rehabilitation centres throughout Italy, overall serving about 9.000 patients daily  in hospital, outpatient and home  care.  Recently,  considerable  work  has  been  carried  out  to optimize  rehabilitation  processes  and  clinical  protocols,  in  order  to uniform  them  and  achieve  standardized  procedures  with  objective measurement on their efficacy and efficiency.  

Within  this  context,  the  robotic  assisted  rehabilitation  was  first implemented in 2015. Nowadays, nine FDG centres are equipped with robots able to deliver rehabilitation by exercise  in augmented reality environment.  To  account  for  sustainability,  an  organizational model was  developed  that  includes  a  therapist  to monitor  1  to  4  patients working  on  robots  within  45  minutes  individual  sessions.  The introduction of this model into clinical practice brought about the need to review the management process.  

Following  a  simulation  considering  the  entire  process,  a  scheduling system was developed, able to guarantee the saturation of the robots during each slot of the day by selecting patients at different  levels of impairment.  Furthermore,  a  data  centralization  process  was implemented  by  networking  the  robots  within  the  Foundation’s  IT infrastructure  and  aggregating  their  data  into  a  central  database. 

Page 2: Service / Methodology · Business intelligence dashboards have been purposely created to offer services to managers, clinicians and researchers. The dashboards allow controlling the

 

.

Business intelligence dashboards have been purposely created to offer services  to  managers,  clinicians  and  researchers.  The  dashboards allow controlling the use of resources and technologies by managers (see  Attachment  1),  monitoring  the  patients’  performances  and generating reports (see Attachment 2) to be included in the patients’ clinical  record;  finally,  they  allow  researchers  to  access  anonymized instrumental  data  and  clinical  scales  for  research  purposes.  This approach allowed to evaluate both the clinical efficacy and the process effectiveness,  based  on  a  large  set  of  real‐world  data  (28.000+ treatments so far), in a value‐based healthcare perspective. 

The  data  analysis  system was  first  used  to  supervise  a Multicenter Randomized Controlled Trial (see Attachment 3: 247 participants in 8 FDG centres along 18 months), which showed the efficacy of robotic rehabilitation for the upper limb treatment in subacute stroke patients (Trial registr.number: http://www.clinicaltrials.gov NCT02879279).  

After  the  trial,  the data monitoring system was used  to monitor  the follow‐up of  robotic  rehabilitation  in  the 9 FDG centers,  showing an important  increase  of  the  robotic  rehabilitation  sessions  (see Attachment  4).  The  centralized  control  of  the  robots’  operational activity also allowed to identify the centers where robots had not been used  at  their  full  potential,  triggering  training  actions  on  clinical managers and operators.   

Partners Nine Rehabilitation Centres of the Don Gnocchi Foundation: Milano IRCCS, Rovato, La Spezia, Fivizzano, Firenze, Roma SM Provvidenza, Roma SM Pace, Sant’Angelo dei Lombardi, Acerenza 

Staff and Resources  

Core group: 3 Engineers, 2 Physicists, 2 Physicians, 1 Physiotherapist  

Acknowledgements: all medical doctors and therapist involved in the robotic assistive rehabilitation treatments of all nine centres. 

Duration  2 years (ongoing) 

Finances  FDG  

Author Names: Furio Gramatica, Valerio Gower, Filippo Benetti, Irene Aprile, Marco Germanotta, Marta Beorchia Contact Email: [email protected]

URL https://www.dongnocchi.it/@servizi/riabilitazione-robotica-e-con-tecnologie-avanzate (in Italian language

Attachments

Attachment 1: screenshots of the Dashboard for Managers Attachment 2: example of Patient Report generated by the

dashboard Attachment 3: clinical trial workflow Attachment 4: Trend analysis of robotic rehabilitation following the

data system implementation

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Page 4: Service / Methodology · Business intelligence dashboards have been purposely created to offer services to managers, clinicians and researchers. The dashboards allow controlling the

Relazione attività riabilitazione robotica di Nome fittizio

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Dati anagraficiNome e Cognome: Nome fittizioLuogo di nascita: MILANOData di nascita: 01/01/1950Sesso: MCodice Fiscale:Centro di riferimento: Milano SMN

Sintesi attività di riabilitazione roboticaNumero totale sessioni di riabilitazione robotica: 30

Mappa accessi alla palestra robotica arto superiore1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

01-201702-201703-201704-201705-201706-201707-2017

Distribuzione attività roboticheNumero Valutazioni Numero Esercizi Distribuzione esercizi (%)

Amadeo 36 35 62,7Pablo 0 53 17,6Diego 2 1 1,3Motore 9 38 18,4Tymo 0 0 0,0Myro 0 0 0,0

Valutazioni strumentaliValutazioni Forza della mano

Data Lato Movimento Pollice [N] Indice [N] Medio [N] Anulare [N] Mignolo [N] Mano [N]20/01/2017 Des Estensione 5,02 0,86 0,51 3,0420/01/2017 Des Flessione 19,83 13,05 5,29 3,44 1,99 32,5120/01/2017 Des Estensione20/01/2017 Des Flessione 12,63 13,21 3,74 1,92 0,51 29,2108/02/2017 Des Estensione 2,31 0,77 1,00 0,9208/02/2017 Des Flessione 6,46 3,32 0,97 1,09 1,55 9,5217/02/2017 Des Estensione 0,36 2,54 1,12 0,06 0,01 2,4617/02/2017 Des Flessione 3,33 14,63 9,27 8,05 16,93 39,2717/02/2017 Des Estensione 3,93 8,88 2,49 0,12 1,41 9,3717/02/2017 Des Flessione 0,64 16,24 9,16 5,50 2,56 31,2903/03/2017 Des Estensione 6,77 1,81 0,20 0,79 7,4103/03/2017 Des Flessione 0,30 13,18 10,46 10,72 6,91 41,2303/03/2017 Des Estensione 0,03 8,37 1,55 0,17 0,24 5,2903/03/2017 Des Flessione 0,36 16,41 12,28 11,80 7,68 47,3603/03/2017 Des Estensione 0,07 8,64 0,91 6,6403/03/2017 Des Flessione 0,30 17,45 11,90 11,29 6,36 46,5407/06/2017 Des Estensione 1,55 3,7507/06/2017 Des Flessione 1,07 9,03 24,29 9,89 5,04 46,73

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Relazione attività riabilitazione robotica di Nome fittizio

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06/02/2017 15/03/2017 21/04/2017 28/05/2017 04/07/20170

20

40

Flessione Mano [N]

Lato sinistroLato destroLato ignoto

06/02/2017 15/03/2017 21/04/2017 28/05/2017 04/07/20170

5

10

Estensione Mano [N]

Lato sinistroLato destroLato ignoto

Valutazioni Range of Motion spallaData Codice Lato Tempo [s] Precisione [%] Area coperta

[m^2]Tasso di successo

20/01/2017 R-1 Des 118,44 89,89 0,11 1,0020/01/2017 R-2 Des 125,47 86,41 0,11 0,9920/01/2017 R-3 Des 103,83 85,36 0,12 1,0017/02/2017 R-4 Des 65,11 90,93 0,11 1,0017/02/2017 R-5 Des 53,53 91,20 0,11 1,0003/03/2017 R-6 Des 49,04 86,84 0,13 1,0009/05/2017 R-7 Des 45,36 71,41 0,13 1,0011/05/2017 R-8 Des 60,77 91,21 0,10 1,0007/06/2017 R-9 Des 57,43 93,24 0,10 1,00

06/02/2017 15/03/2017 21/04/2017 28/05/2017 04/07/20170

50

100

150Tempo [s]

Lato sinistroLato destroLato ignoto

06/02/2017 15/03/2017 21/04/2017 28/05/2017 04/07/20170

50

100

Precisione [%]

Lato sinistroLato destroLato ignoto

06/02/2017 15/03/2017 21/04/2017 28/05/2017 04/07/20170

0,05

0,1

0,15Area coperta [m^2]

Lato sinistroLato destroLato ignoto

06/02/2017 15/03/2017 21/04/2017 28/05/2017 04/07/20170

0,5

1

Tasso di successo

Lato sinistroLato destroLato ignoto

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Relazione attività riabilitazione robotica di Nome fittizio

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Grafici di dettaglio valutazioni ROM e Forza spalla

Data: 20-01-2017 Codice: R-1

Data: 20-01-2017 Codice: R-2

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Relazione attività riabilitazione robotica di Nome fittizio

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Data: 20-01-2017 Codice: R-3

Data: 17-02-2017 Codice: R-4

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Relazione attività riabilitazione robotica di Nome fittizio

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Data: 17-02-2017 Codice: R-5

Data: 03-03-2017 Codice: R-6

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Relazione attività riabilitazione robotica di Nome fittizio

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Data: 09-05-2017 Codice: R-7

Data: 11-05-2017 Codice: R-8

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Relazione attività riabilitazione robotica di Nome fittizio

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Data: 07-06-2017 Codice: R-9

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CONSORT 2010 Flow Diagram 

Assessed for eligibility (n=631)

Excluded (n=384)    Not meeting inclusion criteria (n=348)    Declined to participate (n=2)    Other reasons (n=34)

Allocated to RTG (n=123)

 Received allocated intervention (n= 111) 

 Did not receive allocated intervention (n=12)

(11 never started treatment, 1 death) 

Allocated to CG (n=124)

 Received allocated intervention (n=113) 

 Did not receive allocated intervention (n=11)

(11 never started treatment) 

Allocation 

Randomized (n=247)

Enrollment 

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Robotic Rehabilitation Trend Analysis

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2015 -07

2015 -09

2015 -11

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2016 -03

2016 -05

2016 -07

2016 -09

2016 -11

2017 -01

2017 -03

2017 -05

2017 -07

2017 -09

2017 -11

2018 -01

2018 -03

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Year - Month

END OF CLINICAL TRIAL