Post Stroke Intensive Rehabilitation: Predictors of Outcome and Response to Specific Interventions
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- change in Modified Barthel Index (mBI)
研究概览
简要总结
Prospective observational cohort study, with 6 months follow up, to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke. All patients will be evaluated with a standardized protocol. Functional recovery will be assessed at the discharge and after a period of 6 months.
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 implications. Post-acute intensive rehabilitation is recommended in patients with neurological deficits, but standardized evaluation protocols are essential for evaluate the efficacy of rehabilitation and for the early identification of prognostic factors of recovery. The search for biomarkers of response to specific treatments aimed to customizing the intervention. Recent studies highlight the importance of neurophysiological markers as predictors of post-stroke epilepsy onset and prognosis. Also genetic substrate and epigenetic mechanisms have a prognostic role; the latter may be modified by the administration of Selective Serotonin Reuptake Inhibitor (SSRI) drugs, largely prescribed according to guidelines in post-stroke depression, confirming the neurotrophic role of these drugs postulated in many studies but never demonstrated in vivo in humans. Specific physiotherapeutic interventions also seem to stimulate optimal functional recovery and brain neuroplasticity, in particular those based on the intensive repetition of tasks, such as robotics and Mirror Therapy. Given that the mechanisms of neuronal plasticity activated by these interventions are presumably different, it is hypothesizable that there are specific predictors of response for each of them.
The primary endpoint of this study is to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke, evaluated with standardized protocol. Recovery will be assessed at discharge and at follow-up after 6 months.
Secondary endpoints are:
- evaluate the development of post-stroke epilepsy according to the presence of early clinical seizures or electroencephalographic (EEG) anomalies identified at admission to rehabilitation;
- demonstrate in vivo the activation of neuroplasticity by serotonin reuptake inhibitors drugs;
- evaluate in patients with hemiplegia / hemiparesis of upper limb undergoing Mirror Therapy, robotic rehabilitation and traditional physiotherapy, the presence of specific factors predictive of functional recovery, and of response to different treatments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 未提供
排除标准
- •Stroke occurred more than 30 days after the transfer to intensive rehabilitation
- •Additional exclusion criteria for Epigenetic subproject (for retrospective analysis):
- •history of major psychiatric disorder or recent exacerbation
- •global aphasia
- •refusal of the patient to participate in the study.
结局指标
主要结局
change in Modified Barthel Index (mBI)
时间窗: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Functional recovery; Score from 0 to 100; higher values represent a better outcome.
次要结局
- change in Modified Rankin score(Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in Oxford Cognitive Score (OCS)(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in Hospital Anxiety and Depression Scale (HADS)(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in Fugl Meyer Assessment (FMA)(Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in National Institute of Health Stroke Scale (NIHSS)(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in communication ability (Scala di disabilità comunicativa -SDC)(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in Trunk Control Test (TCT)(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- Post Stroke Epilepsy(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in Functional Ambulation Classification (FAC)(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in Numeric Rating Score (NRS) -Pain(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in Ashworth spasticity scale(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
- change in serum Brain Derived Neurotrophic factor (BDNF) epigenetic profile(Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2)
研究者
Francesca Cecchi
Principal Investigator
Fondazione Don Carlo Gnocchi Onlus
