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Completed

NCT Number: NCT03968627

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione don Gnocchi

Florence, 50143, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rehabilitative intervention

Other

intensive multidisciplinar rehabilitation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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;

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 30, 2019
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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