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

NCT ID: NCT03968627

Last Updated: 2019-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 443 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-02-01

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.

Detailed 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.

Conditions

Stroke; Rehabilitation

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Rehabilitative intervention

Intervention Type: OTHER

intensive multidisciplinar rehabilitation

Interventions

Rehabilitative intervention

intensive multidisciplinar rehabilitation

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Francesca Cecchi

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesca Cecchi, Physician

Role: PRINCIPAL_INVESTIGATOR

IRCCS Don Carlo Gnocchi

Locations

Fondazione don Gnocchi

Florence, , Italy

Countries

Italy

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Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Dongnocchi_pilot

Identifier Type: -

Identifier Source: org_study_id