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临床试验/NCT04691102
NCT04691102招募中不适用

Dynamic Postural Stability Assessment in Neurorehabilitation

I.R.C.C.S. Fondazione Santa Lucia1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Inertial sensors-based assessment

研究概览

简要总结

Postural and balance disorders are common in neurological disorders. They are often associated with reduced mobility and fear of falling, which strongly limit independent activities of daily living (ADL), compromise the quality of life and reduce social participation. Here the investigators apply an existing software solution to: 1) obtain biomarkers of gait deficits in 5 neurological conditions, 2) develop an automatic procedure supporting clinicians in the early identification of patients at high risk of falling as to tailor rehabilitation treatment; 3) longitudinally assess these patients to test the efficacy of rehabilitation. High-density electroencephalography (EEG), and inertial sensors located at lower limbs and at upper body levels will be used to extract the most appropriate indexes during motor tasks. The ultimate goal is to develop cost-effective treatment procedures to prevent recurrent falls and fall-related injuries and favour the reintegration of the patient into everyday activities. The first hypothesis of this study is that clinical professionals (e.g., medical doctors and rehabilitative staff) would strongly benefit from the possibility to rely on quantitative, reliable and reproducible information about patients motor deficits. This piece of information can be nowadays readily available through miniaturized wearable technology and its information content can be effectively conveyed thanks to ad hoc software solution, like the A.r.i.s.e. software. The second hypothesis of the present study is that early identification of patients at high risk of dependence and the subsequent application of personalized treatment would allow for cost-effective treatment procedures to favor the autonomy into everyday activities. The results of this project could represent a valuable support in the clinical reasoning and decision-making process.

研究设计

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

入排标准

年龄范围
15 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Inertial sensors-based assessment

时间窗: Baseline

Set of seven magneto-inertial sensors (Opal, APDM Inc., Portland, Oregon, USA). Gait quality indices related to dynamic stability, symmetry and smoothness will be extracted from the sensors' signals after the execution of a 10-Meter-Walk (10MWT), Figure-of-8-Walk (F8WT), and Fukuda-Stepping test (FST)

次要结局

  • Dynamic Gait Index (DGI)(Baseline)
  • Berg Balance Scale (BBS)(Baseline)
  • Balance Evaluation System Test (Mini-BESTest)(Baseline)
  • Electroencephalography (EEG)(Baseline)

研究者

发起方
I.R.C.C.S. Fondazione Santa Lucia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Tramontano

Head of Rehabilitation Services

I.R.C.C.S. Fondazione Santa Lucia

研究点 (1)

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