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临床试验/NCT05788133
NCT05788133已完成不适用

The Role of Humanoid Robot in Neuropsychological Assessment and Conducting Cognitive Training in Patients With Dementia and Severe Brain Injury

IRCCS Centro Neurolesi "Bonino-Pulejo"2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2022年9月28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
65
试验地点
2
主要终点
mini mental state examination (MMSE)

研究概览

简要总结

The role of humanoid robot in neuropsychological assessment and conducting cognitive training in patients with dementia and severe brain injury" Objectives Use of robotic solutions to carry out diagnostic and rehabilitation intervention in order to recover cognitive and relational performance of patients with dementia and severe brain injury.

Study Design. Observational Materials and Methods. Eighty subjects (25 with mild-moderate dementia and 25 patients with severe brain injury) will be enrolled. Patients will undergo neurological examination with collection of all medical history and information on current clinical condition. After that, they will undergo administration of neuropsychological tests via humanoid robot and two months of cognitive rehabilitation sessions.

Inclusion criteria

  • Over 18 years of age;
  • Patients with a moderately impaired cognitive profile;
  • Written consent from the legal guardian or the patient himself/herself. Exclusion criteria.
  • Patients with language comprehension deficits;
  • Patients with disorders of consciousness;
  • Patients who are unable to provide a localized, context-appropriate response; and All eligible patients will undergo cognitive assessment using the robot at the time of enrollment (T0), and after 2 months of rehabilitation treatment (T1)

Translated with www.DeepL.com/Translator (free version)

详细描述

This is a nonpharmacological interventional study. Clinical and neuropsychological variables will be collected by the robotic system and transferred to a platform where it will be possible to verify the performance achieved by the patient. All patients will be evaluated through the robot with the indispensable support of the neuropsychologist. Patients will be recruited from the outpatient neurology and severe brain injury and neurodegenerative disease departments of the IRCCS Bonino- Pulejo Neurolesi Center in Messina. The rehabilitation treatment period and test administration will be carried out before the start of treatment (T0), after 2 months of treatment (T1).

The project will allow a high technological increase in robotic and informatics solutions available to patients, thanks also to the support of the University, the partnership between complementary companies, an interdisciplinary team capable of designing and developing a new integrated solution for innovative dementia and head injury therapy will be created. Unlike the other existing platforms that mostly use a Web interface and/or application software developed ad hoc, the platform that will be realized is mainly born to be fully integrated and used through an anthropomorphic humanoid robot as a direct communication channel between the content conveyed, the patient and the Tablet device as a reinforcing and feedback element where the patient himself responds and/or interacts with the therapeutic session in progress. In this sense, the robot acts as a performer and receiver of feedback related to the therapeutic process conveyed together with the tablet.

A unique platform of its kind will be developed, capable of managing robots and the self-learning and artificial intelligence platform with the following characteristics:

  • Administer therapeutic contents
  • Track and store the results of your therapy sessions
  • Generate reports and statistics on the results of the training sessions
  • Conveying therapeutic contents through robots and software solutions.
  • Suggest the best therapy according to the therapeutic objectives of the individual patient Depending on the topic addressed, the operator will be able to choose the categories of exercises related to his own therapeutic objective and then create ad hoc sequences directly from the platform. Each exercise can be parameterised by setting, for example, the level of difficulty, duration, etc. Based on the content conveyed, the robot, for example, will perform the session through verbal or physical interaction with the subject and therefore request feedback which can in turn be performed verbally by the subject or through interaction always through the same Tablet. The results of each exercise and each test will be aggregated according to the chosen goal and stored within a centralized service possibly in the Cloud. Within this system there will be a database with the patient's personal data, the therapeutic objectives defined by the neuropsychologist and the results obtained by the patient. Access to this information will be directed exclusively to the doctor/therapist via Tablet or Web and possibly to the family who, via Web access, will be able to observe the progress of the exercises and therefore the improvement and/or deviation towards the set objective.

The study will be divided into three phases. Phase 1: the personal and clinical data of the patients will be recorded on the tablet directly connected to the robot. The patients will be subjected to the administration of neuropsychological tests, which will be proposed directly by the robot with the support of the neuropsychologist. The robot will acquire the answers (right or wrong), the response time, the execution time of the entire exercise and eventually the number of attempts (if the test foresees it). Starting from this information, a percentage evaluation will be deduced which identifies an overall score.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Over 18 years old;
  • Patients with moderately impaired cognitive profile;
  • Written consent from the legal guardian or the patient himself

排除标准

  • Patients with language comprehension deficit;
  • Patients with disorders of consciousness;
  • Patients who are unable to provide a localized and context-appropriate response

结局指标

主要结局

mini mental state examination (MMSE)

时间窗: 2 months

administration MMSE with humanoid robot

次要结局

未报告次要终点

研究者

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

Silvia Marino

Neurologist

IRCCS Centro Neurolesi "Bonino-Pulejo"

研究点 (2)

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