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

June 14, 2019 updated by: Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

443

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50143
        • Fondazione Don Gnocchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
intensive multidisciplinar rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Barthel Index
Time Frame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Urinary catheter
Time Frame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
To assess the presence of urinary catheter
At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
Presence of bed sores
Time Frame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
To assess the presence of bed sores
At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
Communicative Disability scale
Time Frame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
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)
Trunk Control Test
Time Frame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
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)
Numeric Rating Scale for the assessment of pain
Time Frame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
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)
Standardized Audit of Hip Fracture In Europe
Time Frame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
To assess the ambulation;
At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

May 29, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dongnocchi_pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We didn't plan to share these data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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