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Development of a National Protocol for Stroke Rehabilitation in a Multicenter Italian Institution
| Condition or disease | Intervention/treatment |
|---|---|
| Stroke Rehabilitation | Other: Rehabilitative intervention |
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 |
| 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 : | February 1, 2017 |
| Actual Primary Completion Date : | January 1, 2018 |
| Actual Study Completion Date : | February 1, 2018 |
| 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
|
- 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
- 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
- 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
- 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)
- 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)
- 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)
- 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;
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
| Italy | |
| Fondazione don Gnocchi | |
| Florence, Italy, 50143 | |
| Principal Investigator: | Francesca Cecchi, Physician | IRCCS Don Carlo Gnocchi |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 29, 2019 | ||||
| First Posted Date | May 30, 2019 | ||||
| Last Update Posted Date | June 18, 2019 | ||||
| Actual Study Start Date | February 1, 2017 | ||||
| Actual Primary Completion Date | January 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures |
change in modified Barthel Index (mBI) [ Time Frame: At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks) ] Functional recovery; score from 0 to 100; higher values represent a better outcome
|
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| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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 | ||||
| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
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| Intervention | Other: Rehabilitative intervention
intensive multidisciplinar rehabilitation
|
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| Study Groups/Cohorts | 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
Intervention: Other: Rehabilitative intervention
|
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
443 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | February 1, 2018 | ||||
| Actual Primary Completion Date | January 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03968627 | ||||
| Other Study ID Numbers | Dongnocchi_pilot | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus | ||||
| Study Sponsor | Fondazione Don Carlo Gnocchi Onlus | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Fondazione Don Carlo Gnocchi Onlus | ||||
| Verification Date | June 2019 | ||||
