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

Sponsor
Fondazione Don Carlo Gnocchi Onlus (Other)
Overall Status
Completed
CT.gov ID
NCT03968627
Collaborator
(none)
443
Enrollment
1
Location
12
Actual Duration (Months)
36.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitative intervention

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 Design

Study Type:
Observational
Actual Enrollment :
443 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Modified Barthel Index [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

Secondary Outcome Measures

  1. Presence of Urinary catheter [At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)]

    To assess the presence of urinary catheter

  2. Presence of bed sores [At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)]

    To assess the presence of bed sores

  3. Communicative Disability scale [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)

  4. Trunk Control Test [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)

  5. Numeric Rating Scale for the assessment of pain [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)

  6. Standardized Audit of Hip Fracture In Europe [At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks)]

    To assess the ambulation;

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione don Gnocchi Florence Italy 50143

Sponsors and Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: Francesca Cecchi, Physician, IRCCS Don Carlo Gnocchi

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Francesca Cecchi, Dr., Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier:
NCT03968627
Other Study ID Numbers:
  • Dongnocchi_pilot
First Posted:
May 30, 2019
Last Update Posted:
Jun 18, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Francesca Cecchi, Dr., Fondazione Don Carlo Gnocchi Onlus
Stroke
Rehabilitation
Protocol
Evidence-based
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Jun 18, 2019