跳至主要内容
临床试验/NCT04386863
NCT04386863已完成不适用

Taxonomy of Neurorehabilitation Treatments and Outcome Measures: a Multicentre Italian Study

Fondazione Don Carlo Gnocchi Onlus7 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2018年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
204
试验地点
7
主要终点
Change in Two minute walking test

研究概览

简要总结

The main aims of the observational study are to taxonomize the contents of rehabilitation understanding goals and treatments provided to people with Parkinson Disease(PD) and Multiple Sclerosis(MS) and Stroke and their impact on the outcomes

详细描述

In recent years, neurological rehabilitation focused on evaluating patient's problems, with no rationalization of therapeutic interventions. Few researches investigated the contribution of the components of a neurorehabilitation program to the clinical outcome in everyday clinical practice. Moreover, there is no a standard method to categorize rehabilitative interventions, making difficult to explain why subjects improve and which of the various treatments is more effective. Thus, it was decided to build a multicentre network to collect data using a taxonomy tool developed to provide information on the goals of rehabilitation and to categorize rehabilitation interventions

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Multiple Sclerosis
  • Diagnosis of Parkinson Disease
  • Diagnosis of Stroke
  • Participants' rehabilitation program must include at least 10 sessions of physical therapy.

排除标准

  • Unable to understand the aim of the study or unable to sign the informed consent form;

结局指标

主要结局

Change in Two minute walking test

时间窗: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks

The Two minute walking test is a test used to evaluate functional exercise capacity. Subjects are instructed to walk as fast as possible in 2 minutes, along a 30-m hallway. Total distance walked is recorded

Change in Box and Blocks test

时间窗: Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks

The Box and Block Test measures unilateral gross manual dexterity. The test consists of a box with a partition in the middle and is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial.

次要结局

  • Change in Reaching Performance Scale(Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks)
  • Change in Manual Ability Measurement(Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks)
  • Change in Activities-specific Balance Confidence scale(Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks)
  • Change in Cognitive dual-task Timed-Up-and-Go test(Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks)
  • Modified Barthel Index(Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks)
  • Change in modified Dynamic Gait Index(Baseline and after a minimum of 2 weeks up to a maximum of 20 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Davide Cattaneo

Principal Investigator

Fondazione Don Carlo Gnocchi Onlus

研究点 (7)

Loading locations...

相似试验