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临床试验/NCT03921697
NCT03921697Unknown不适用

Parkinson App SmarTphone Aimed to Improve Walking Ability and Reduce Fall (P.A.S.T.A.)

Fondazione Don Carlo Gnocchi Onlus1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年4月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Correlations between inertial sensor-derived measures of motor function and clinician ratings during performance of the UPDRS part 3 and total exam at baseline

研究概览

简要总结

Gait impairments of patients with Parkinson's disease (PD) limit the independence in the daily activities and sensibly increase the risk of falls. New gait analysis methods, based on wearable inertial sensors, have been proposed to track the gait features during treatment and in real-life conditions. Gait training based on auditory cues as Rhythmical Auditory Stimulation (RAS) have preliminarily shown positive effects improving gait velocity, stride length, step cadence of walking in PD. In the current project, the research group will aim to develop a smartphone application (Parkinson App Smartphone Aimed: P.A.St.A.) integrated with sensors and RAS. In a second time, investigators will analyze the spatio-temporal gait parameters obtained by the wearable sensors and the sociodemographic and clinical data, thus generating a big data set, to improve the knowledge about current pharmacological therapies and rehabilitation.

详细描述

Parkinson's disease (PD) is a chronic and progressive movement disorder, mainly due to an altered motor control. Gait impairments are the primary symptoms in patients with PD, with a decreased step length and walking speed, abnormal gait phases distribution, inconstant pace, gait asymmetry and reduced joint coordination. The postural instability and the deterioration of the gait features sensibly increase the risk of falls in these patients, resulting in loss of independence and a worsening of long-term prognosis. It has been clearly demonstrated that motor impairments are connected to a dysfunction of basal ganglia, a brain structure that works as a "pacemaker" for the activation (and deactivation) of each sub-movement within a repetitive movement sequence. Disruption of internal rhythmic cues in PD may explain the poor smoothness of the movement execution and the difficulties in regulating stride length, resulting in a cadence increase. Levodopa therapy is the most effective treatment to improve the symptoms in PD, but a long-term administration reduces its efficiency over time and it is responsible for collateral effects (dyskinesia). Hence, researches have investigated alternative non-pharmacological approaches, based on auditory cues as the Rhythmical Auditory Stimulation (RAS). A large number of studies have reported positive effects both after a single session of treatment and after longer training programs, with improved gait velocity, cadence, and stride length as well as in the symmetry of muscle activation for upper and lower extremities. In such studies, RAS frequencies are pre-set as percentages of the patient's preferred walking frequency. Because the duration of all the therapies may change over time, it is necessary a continuous adjustment of the dosage and type of treatment, based both on patients' monitoring of the symptoms and on objective evaluations. Gait analysis (GA) methods have been proposed and validated for the study of physiologic gait and in several diseases. The traditional systems of GA are based on optoelectronic systems, but they are expensive, not portable and requiring skilled operators. The assessment is always performed in laboratories with experimental set-ups, likely different from real-life walking (noise environments, presence of objects and people or unlevelled pavement, different colors).

Consequently, traditional GA is not reliable for the daily control of the treatments or for the assessment of the real-life situations. Recently, researchers have developed wearable systems, based on Inertial Measurement Units (IMUs). Even if a considerable number of studies have explored the validity of IMUs analysis, very few have been involved in PD motion analyses. During the last few years, a set of wearable devices embedding inertial sensors, are spread on the market as low-cost solutions for monitoring human motion activities. While, they still have to be fully validated in accuracy, these systems can provide the user information to track his/her own activity. This persuasive technology has a terrific potential to enhance physical activity and motivation of the patients, with the advantage of prolonged and continuous recording.

The use and the analyses of a large amount of objective data (big data set) is the new frontier for an efficient use of scientific time and resources, engaging the care coordination program, saving economic resources, and providing a higher quality of care. In addition, these systems, integrated with a web-based application, telemedicine and mobile smartphones, could help clinicians to address more properly the treatments through a real-time monitoring in an everyday life. Our research group has been involved in the clinical evaluation of different aspects of gait quality in many neurological conditions, PD included. Investigators have already shown as wearable accelerometers could be useful in the quantitative assessment of the dynamic gait stability, in correlation with clinical scores. Researchers have also found that accelerations could be altered in a pathology-specific manner (intellectual disabilities performing different tasks simultaneously). A similar condition can be observed also in PD, showing that only the intrinsic gait harmony significantly correlate with severity of gait impairments. In the recent years, a lot of wearable tools have become available to quantify the daily activity. This is particularly important for possible therapeutic use of the RAS, that is addressed to restore a harmonic pace in patients with PD.

Specific Aim 1: To analyze motor pattern in PD patients in real life setting, gait features will be obtained by wearable sensors in order to relate them with clinical and demographical data.

Specific Aim 2: To improve walking abilities and to reduce the risk of falls in patients with PD, researchers will test a real-time acoustic feed-back (RAS) and alerts from integrated sensors connected with a suitable and easy-to-use application for smartphones.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic Parkinson's disease diagnosed by a neurologist
  • Ability to sign informed consent

排除标准

  • Inability to sign informed consent
  • Inability to fill out questionnaires (i.e. due to poor vision, inability to read, etc)
  • Presence of psychiatric diseases (episode or any form of psychosis, diagnosed by a psychiatrist in the last year).
  • Age under 18 yrs old

结局指标

主要结局

Correlations between inertial sensor-derived measures of motor function and clinician ratings during performance of the UPDRS part 3 and total exam at baseline

时间窗: Fourteen days

Features extracted from continuous accelerometer signals recorded during real life for fourteen days, will be correlated with each relevant component of the UPDRS part 3 and corresponding clinician ratings to quantify the relationship between these measures.

次要结局

  • Time Up&Go(Baseline)

研究者

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

Augusto Fusco

Principal Investigator; M.D.; Ph.D.

Fondazione Don Carlo Gnocchi Onlus

研究点 (1)

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