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

Stroke Clinical Trial

Official title:

Development of a National, Evidence Based Protocol for Stroke Rehabilitation in a Multicenter Italian no Profit Institution: Implementation and Results of a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968627
• Other study ID #: Dongnocchi_pilot
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: June 2019
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Despite progress in the treatment of cerebrovascular diseases in the acute phase, stroke remains a catastrophic event with important public health consequences. According to the most recent ASA/AHA guidelines, a specific and intensive rehabilitation is recommended in patients with neurological impairments after stroke in the postacute phase.

In this regard, the use of standardized shared evaluation protocols, developed according to the ICF model is strongly recommended to evaluate the effectiveness of rehabilitative treatments on large populations of stroke patients affected and, possibly, to allow the identification of biomarkers, identifiable in the acute phase and in the immediate post-acute period, to predict prognosis and to orient rehabilitation care.

The Don Carlo Gnocchi Foundation ONLUS is one of the most important health groups in Italy, with over 3,700 beds and 28 Centers, active in 9 Italian regions (Northern, Central and Southern Italy). The don Gnocchi Rehabilitation Hospitals are accredited by the different Regional Health Services all over Italy.

During 2016 and based on 60 years of experience, an harmonization and redefinition of the Foundation rehabilitative model was carried out. Such process was in line with the Evidence Based approach of Cochrane Rehabilitation.

The Medical Committee was the first step for the national identification of a group of health professionals which includes, in addition to MD specialists, all health professions involved in Interdisciplinary Rehabilitation Team.

The first objective was to develop consensus over national Rehabilitation protocols for the most prevalent conditions addressed to in our Rehabilitation Hospitals. Given the prevalence of neurological rehabilitation treatments and in particular Stroke, the Medical Direction appointed a group of 6 Specialists, who entrusted the task of developing a Stroke rehabilitation don Gnocchi Protocol.

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, and the preliminary results of the pilot study, limited to the treatment of intensive post-acute inpatient rehabilitation, with the objective of verifying the feasibility of the protocol and comparing the outcomes for stroke inpatient rehabilitation with those of the 3 years prior to implementation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: February 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age 18-90;

• acute ischemic or hermorragic stroke (within 30 days);

• consent both to participate and to anonymous data processing.

Exclusion Criteria:

• stroke occured more than 30 days after the transfer to intensive rehabilitation;

• patient's refusal to participate in the study.

Related Conditions & MeSH terms

• Rehabilitation
• Stroke

Intervention

Other:
• Rehabilitative intervention
intensive multidisciplinar rehabilitation

Locations

Country	Name	City	State
Italy	Fondazione don Gnocchi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (24)

Alcantara CC, García-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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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 Fd

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. Review. — View Citation

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. Review. — View Citation

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. Review. Erratum in: Lancet. 2014 Jan 18;383(9913):218. — View Citation

Habegger S, Wiest R, Weder BJ, Mordasini P, Gralla J, Häni 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2003 Aug 7. — View Citation

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. — View Citation

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

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.

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. — View Citation

Ramachandran VS, Rogers-Ramachandran D, Cobb S. Touching the phantom limb. Nature. 1995 Oct 12;377(6549):489-90. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Wagle J, Farner L, Flekkøy K, Bruun Wyller T, Sandvik L, Fure B, Stensrød 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. — View Citation

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. Review. Erratum in: Stroke. 2017 Feb;48(2):e78. Stroke. 2017 Dec;48(12 ):e369. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presence of Urinary catheter	To assess the presence of urinary catheter	At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
Secondary	Presence of bed sores	To assess the presence of bed sores	At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
Secondary	Communicative Disability scale	To assess the disability in communication; ranging from 0 (complete disability) to 4 (no disability in communication)	At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
Secondary	Trunk Control Test	To assess trunk control; ranging from 0 (no control) to 100 (complete control)	At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
Secondary	Numeric Rating Scale for the assessment of pain	Assessment of the presence of pain; ranging from 0 (no pain) to 10 (the worst possible pain)	At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
Secondary	Standardized Audit of Hip Fracture In Europe	To assess the ambulation;	At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)