Development of a National, Evidence Based Protocol for Stroke Rehabilitation in a Multicenter Italian no Profit Institution: Implementation and Results of a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- Modified Barthel Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-90;
- •acute ischemic or hermorragic stroke (within 30 days);
- •consent both to participate and to anonymous data processing.
排除标准
- •stroke occured more than 30 days after the transfer to intensive rehabilitation;
- •patient's refusal to participate in the study.
结局指标
主要结局
Modified Barthel Index
时间窗: 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
次要结局
- Presence of Urinary catheter(At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks))
- Presence of bed sores(At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks))
- Communicative Disability scale(At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks))
- Trunk Control Test(At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks))
- Standardized Audit of Hip Fracture In Europe(At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks))
- Numeric Rating Scale for the assessment of pain(At Time 0: Admission; and at Time 1: Discharge (up to 3/4 weeks))
研究者
Francesca Cecchi
Dr.
Fondazione Don Carlo Gnocchi Onlus