Clinical trial NCT03968627: Development of a National Protocol for Stroke Rehabilitation in a Multicenter Italian Institution
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Rehabilitation
Keywords: Stroke
Rehabilitation
Protocol
Evidence-based
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Modified Barthel Index
timeFrame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
Secondary outcomes:
measure: Presence of Urinary catheter
timeFrame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
measure: Presence of bed sores
timeFrame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
measure: Communicative Disability scale
timeFrame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
measure: Trunk Control Test
timeFrame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
measure: Numeric Rating Scale for the assessment of pain
timeFrame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
measure: Standardized Audit of Hip Fracture In Europe
timeFrame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Fondazione don Gnocchi
Study officials:
affiliation: IRCCS Don Carlo Gnocchi
name: Francesca Cecchi, Physician
role: PRINCIPAL_INVESTIGATOR
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