Development of a National Protocol for Stroke Rehabilitation in a Multicenter Italian Institution

NCT03968627 | Completed DMC

• 1 other identifier: Dongnocchi_pilot
• Study Type: observational
• Target: 443
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the importance to use standardized shared protocols in the rehabilitative setting of cerebrovascular diseases, an harmonization and redefinition of the Don Carlo Gnocchi Foundation rehabilitative model was carried out. Such process was in line with the Evidence Based approach of Cochrane Rehabilitation.

Conditions

Stroke; Rehabilitation

Keywords

Stroke; Rehabilitation; Protocol; Evidence-based

Outcome Measures

Primary Outcomes (1)

• Modified Barthel Index

  Changes in functional recovery; score from 0 to 100; higher values represent a better outcome

  At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)

Secondary Outcomes (6)

• Presence of Urinary catheter

  At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)

• Presence of bed sores

  At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)

• Communicative Disability scale

  At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)

• Trunk Control Test

  At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)

• Numeric Rating Scale for the assessment of pain

  At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)

Study Arms (1)

Protocol application

The study describes the method and the criteria used in the development of the protocol, the steps followed in its implementation in two Don Gnocchi Foundation Pilot Hospitals

Other: Rehabilitative intervention

Interventions

Rehabilitative intervention OTHER

intensive multidisciplinar rehabilitation

Protocol application

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

443 patients all patients with stroke accessing the Don Gnocchi Rehabilitation facility of Marina di Massa and Fivizzano, by authorization of the local public health authority specialists in Physical Medicine and Rehabilitation were enrolled.

You may qualify if:

• age 18-90;
• acute ischemic or hermorragic stroke (within 30 days);
• consent both to participate and to anonymous data processing.

You may not qualify if:

• stroke occured more than 30 days after the transfer to intensive rehabilitation;
• patient's refusal to participate in the study.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione don Gnocchi

Florence, 50143, Italy

Location

Related Publications (26)

• Alcantara CC, Garcia-Salazar LF, Silva-Couto MA, Santos GL, Reisman DS, Russo TL. Post-stroke BDNF Concentration Changes Following Physical Exercise: A Systematic Review. Front Neurol. 2018 Aug 28;9:637. doi: 10.3389/fneur.2018.00637. eCollection 2018.

  PMID: 30210424 BACKGROUND

• Balkaya M, Cho S. Genetics of stroke recovery: BDNF val66met polymorphism in stroke recovery and its interaction with aging. Neurobiol Dis. 2019 Jun;126:36-46. doi: 10.1016/j.nbd.2018.08.009. Epub 2018 Aug 15.

  PMID: 30118755 BACKGROUND

• Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed Definitions and a Shared Vision for New Standards in Stroke Recovery Research: The Stroke Recovery and Rehabilitation Roundtable Taskforce. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.

  PMID: 28934920 BACKGROUND

• Boyd LA, Hayward KS, Ward NS, Stinear CM, Rosso C, Fisher RJ, Carter AR, Leff AP, Copland DA, Carey LM, Cohen LG, Basso DM, Maguire JM, Cramer SC. Biomarkers of Stroke Recovery: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):864-876. doi: 10.1177/1545968317732680.

  PMID: 29233071 BACKGROUND

• Caleo M. Rehabilitation and plasticity following stroke: Insights from rodent models. Neuroscience. 2015 Dec 17;311:180-94. doi: 10.1016/j.neuroscience.2015.10.029. Epub 2015 Oct 19.

  PMID: 26493858 BACKGROUND

• Connell LA, Smith MC, Byblow WD, Stinear CM. Implementing biomarkers to predict motor recovery after stroke. NeuroRehabilitation. 2018;43(1):41-50. doi: 10.3233/NRE-172395.

  PMID: 30056436 BACKGROUND

• Di Pino G, Pellegrino G, Assenza G, Capone F, Ferreri F, Formica D, Ranieri F, Tombini M, Ziemann U, Rothwell JC, Di Lazzaro V. Modulation of brain plasticity in stroke: a novel model for neurorehabilitation. Nat Rev Neurol. 2014 Oct;10(10):597-608. doi: 10.1038/nrneurol.2014.162. Epub 2014 Sep 9.

  PMID: 25201238 BACKGROUND

• Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.

  PMID: 24449944 BACKGROUND

• Habegger S, Wiest R, Weder BJ, Mordasini P, Gralla J, Hani L, Jung S, Reyes M, McKinley R. Relating Acute Lesion Loads to Chronic Outcome in Ischemic Stroke-An Exploratory Comparison of Mismatch Patterns and Predictive Modeling. Front Neurol. 2018 Sep 11;9:737. doi: 10.3389/fneur.2018.00737. eCollection 2018.

  PMID: 30254601 BACKGROUND

• Kabboord AD, van Eijk M, Fiocco M, van Balen R, Achterberg WP. Assessment of Comorbidity Burden and its Association With Functional Rehabilitation Outcome After Stroke or Hip Fracture: A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2016 Nov 1;17(11):1066.e13-1066.e21. doi: 10.1016/j.jamda.2016.07.028. Epub 2016 Sep 20.

  PMID: 27663529 BACKGROUND

• Kwakkel G, Lannin NA, Borschmann K, English C, Ali M, Churilov L, Saposnik G, Winstein C, van Wegen EEH, Wolf SL, Krakauer JW, Bernhardt J. Standardized Measurement of Sensorimotor Recovery in Stroke Trials: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2017 Sep;31(9):784-792. doi: 10.1177/1545968317732662.

  PMID: 28934918 BACKGROUND

• Kim JM, Stewart R, Park MS, Kang HJ, Kim SW, Shin IS, Kim HR, Shin MG, Cho KH, Yoon JS. Associations of BDNF genotype and promoter methylation with acute and long-term stroke outcomes in an East Asian cohort. PLoS One. 2012;7(12):e51280. doi: 10.1371/journal.pone.0051280. Epub 2012 Dec 11.

  PMID: 23240009 BACKGROUND

• Kim JM, Stewart R, Bae KY, Kim SW, Kang HJ, Shin IS, Kim JT, Park MS, Kim MK, Park SW, Kim YH, Kim JK, Cho KH, Yoon JS. Serotonergic and BDNF genes and risk of depression after stroke. J Affect Disord. 2012 Feb;136(3):833-40. doi: 10.1016/j.jad.2011.09.029. Epub 2011 Oct 20.

  PMID: 22014446 BACKGROUND

• Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.

  PMID: 12907818 BACKGROUND

• Padua, L., Imbimbo, I., Aprile, I., Loreti, C., Germanotta, M., Coraci, D., ... & Carrozza, M. C. (2018, October). The Role of Cognitive Reserve in the Choice of Upper Limb Rehabilitation Treatment After Stroke. Robotic or Conventional? A Multicenter Study of the Don Carlo Gnocchi Foundation. In International Conference on NeuroRehabilitation (pp. 513-517). Springer, Cham.

  BACKGROUND

• Pizzi A, Carrai R, Falsini C, Martini M, Verdesca S, Grippo A. Prognostic value of motor evoked potentials in motor function recovery of upper limb after stroke. J Rehabil Med. 2009 Jul;41(8):654-60. doi: 10.2340/16501977-0389.

  PMID: 19565160 BACKGROUND

• Ramachandran VS, Rogers-Ramachandran D, Cobb S. Touching the phantom limb. Nature. 1995 Oct 12;377(6549):489-90. doi: 10.1038/377489a0. No abstract available.

  PMID: 7566144 BACKGROUND

• Tedesco Triccas L, Meyer S, Mantini D, Camilleri K, Falzon O, Camilleri T, Verheyden G. A systematic review investigating the relationship of electroencephalography and magnetoencephalography measurements with sensorimotor upper limb impairments after stroke. J Neurosci Methods. 2019 Jan 1;311:318-330. doi: 10.1016/j.jneumeth.2018.08.009. Epub 2018 Aug 14.

  PMID: 30118725 BACKGROUND

• Van Peppen RP, Kwakkel G, Wood-Dauphinee S, Hendriks HJ, Van der Wees PJ, Dekker J. The impact of physical therapy on functional outcomes after stroke: what's the evidence? Clin Rehabil. 2004 Dec;18(8):833-62. doi: 10.1191/0269215504cr843oa.

  PMID: 15609840 BACKGROUND

• Wagle J, Farner L, Flekkoy K, Bruun Wyller T, Sandvik L, Fure B, Stensrod B, Engedal K. Early post-stroke cognition in stroke rehabilitation patients predicts functional outcome at 13 months. Dement Geriatr Cogn Disord. 2011;31(5):379-87. doi: 10.1159/000328970. Epub 2011 Jun 29.

  PMID: 21720162 BACKGROUND

• Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

  PMID: 27145936 BACKGROUND

• Yang Y, Zhao Q, Zhang Y, Wu Q, Jiang X, Cheng G. Effect of Mirror Therapy on Recovery of Stroke Survivors: A Systematic Review and Network Meta-analysis. Neuroscience. 2018 Oct 15;390:318-336. doi: 10.1016/j.neuroscience.2018.06.044. Epub 2018 Jul 5.

  PMID: 29981364 BACKGROUND

• Cecchi F, Diverio M, Corbella E, del Zotto E, Marrazzo F, Speranza G, Gabrielli MA, Macchi C, Ricca M, Aprile A. Sviluppo di un protocollo condiviso di Fondazione don Gnocchi (FdG) per la Riabilitazione dello Stroke e sua implementazione in 2 Strutture FdG: Studio Pilota. SIMFER Settembre 2018

  RESULT

• Ministero della salute. Decreto 7 dicembre 2017 - Regolamento recante modifiche ed integrazioni del decreto 27 ottobre 2000, n. 380 e successive modificazioni, concernente la scheda di dimissione ospedaliera (SDO)N.:16/2017

  RESULT

• Basagni B, Hakiki B, Campagnini S, Salvadori E, Grippo A, Paperini A, Castagnoli C, Hochleitner I, Politi AM, Gemignani P, Mosca IE, Franceschini A, Bonotti EB, Sodero A, Mannini A, Pellicciari L, Poggesi A, Macchi C, Carrozza MC, Cecchi F. Critical issue on the extinction and inattention subtest of NIHSS scale: an analysis on post-acute stroke patients attending inpatient rehabilitation. BMC Neurol. 2021 Dec 8;21(1):475. doi: 10.1186/s12883-021-02499-9.

  PMID: 34879861 DERIVED

• Hakiki B, Paperini A, Castagnoli C, Hochleitner I, Verdesca S, Grippo A, Scarpino M, Maiorelli A, Mosca IE, Gemignani P, Borsotti M, Gabrielli MA, Salvadori E, Poggesi A, Lucidi G, Falsini C, Gentilini M, Martini M, Luisi MLE, Biffi B, Mainardi P, Barretta T, Pancani S, Mannini A, Campagnini S, Bagnoli S, Ingannato A, Nacmias B, Macchi C, Carrozza MC, Cecchi F. Predictors of Function, Activity, and Participation of Stroke Patients Undergoing Intensive Rehabilitation: A Multicenter Prospective Observational Study Protocol. Front Neurol. 2021 Apr 8;12:632672. doi: 10.3389/fneur.2021.632672. eCollection 2021.

  PMID: 33897593 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Francesca Cecchi, Physician

  IRCCS Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 30, 2019
• Study Start: February 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)