An Integrated and Multi-perspective Approach to Cognitive-motor Technology Rehabilitation and Telemedicine in Frail Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Dual-Task Cost (DTC)
研究概览
简要总结
Dual performance, which involves the simultaneous execution of motor and cognitive tasks, is a fundamental aspect of everyday functioning. In the elderly population, for example, the ability to manage dual tasks can be significantly impaired, resulting in an increased risk of falls and further cognitive decline. The ability to perform two tasks simultaneously (one motor and one cognitive) is often impaired in patients with chronic sensorimotor and/or cognitive disabilities, with repercussions on both physical and cognitive abilities. Patients with chronic sensorimotor and/or cognitive disabilities consistently show greater deficits in dual performance than healthy individuals, with repercussions on both motor and cognitive functioning. These deficits are influenced by psychological, neural, and disease-specific factors, but targeted interventions and dual-task training can help improve outcomes.
Some authors have pointed out that dual-task training can improve attention, functional mobility, and overall cognitive function more effectively than single-task training. One of the main advantages of dual-task training is the reduction of the risk of falls in the elderly population and in chronic patients with sensorimotor disorders: dual-task training has been shown to improve dynamic balance and stability, even during walking, and cognitive function.
Telerehabilitation is a branch of telemedicine that uses different types of technology to provide remote rehabilitation services. Telerehabilitation, like telemedicine, can be delivered through three distinct mechanisms: synchronous mode, in which the patient and physician communicate in real time using technological tools; remote monitoring mode, in which the patient's condition is monitored remotely; and asynchronous mode, in which there is no simultaneous communication between the parties involved. This approach has proven particularly effective during the recent COVID-19 pandemic, minimizing risks and improving clinical outcomes. In addition, it has proven to be a safe way to monitor clinical parameters, with the possibility of personalized and timely intervention for patients with chronic conditions, leading to improved patient condition and quality of life, while also helping to reduce costs for both the patient and the healthcare system. Asynchronous telemedicine and/or telerehabilitation activities, in which the patient and operator are not online at the same time, also enable patients living in remote areas with limited or unreliable connectivity to receive convenient, flexible, and accessible healthcare services.
详细描述
The project, considering the impact of robotic rehabilitation and asynchronous telerehabilitation on cognitive-motor interference, is highly innovative in terms of the integrated use of technology to improve the quality of life of frail people. Through the proposed therapeutic protocol, it will be possible to further customize the recommended rehabilitation treatments, both in outpatient and home settings, considering the characteristics of the patient and the evolution of the clinical picture. The use of telerehabilitation tools, used asynchronously, will allow greater access to care and widespread rehabilitation throughout the territory, including areas that are difficult to reach or from which patients and their caregivers have difficulty traveling.
The proposed technology, both in the home and outpatient settings, will be able to provide the patient with different types of real-time feedback (visual, auditory, tactile) to increase the level of interaction and involvement with the patient during rehabilitation treatment. In the outpatient setting, this feedback, combined with the constant presence of the physical therapist, will guide the patient during the exercise and various rehabilitation activities proposed. In the home setting, this feedback, combined with telephone monitoring by the healthcare professional, will ensure that the patient does not feel abandoned during the telerehabilitation treatment period, but receives care that is as similar as possible to that provided in an outpatient setting. The integration and synoptic interpretation of data collected with clinical and home technologies will enable better management of the care pathway, allowing for objective performance assessment and the subsequent delivery of personalized and specific treatments for each patient.
The main innovation of the project is the integration and combination of different robotic and technological products: the development of a rehabilitation pathway that ensures continuity between the clinic and the home will lead to the development of a new rehabilitation paradigm that is easily accessible to frail people.
Currently, the scientific literature offers a wide range of scientific articles on robotic rehabilitation and telerehabilitation, but there is still insufficient scientific evidence on the integrated use of outpatient robotic rehabilitation and home-based telerehabilitation, especially in frail individuals with chronic sensorimotor and/or cognitive disorders, particularly with regard to the impact on the simultaneous performance of motor and cognitive tasks. The results obtained from this project will fill the gap in the literature, allowing the dissemination of new knowledge and the development of a new rehabilitation paradigm.
With this in mind, the overall objective of the project will be to identify a new multi-perspective rehabilitation paradigm/pathway that can contribute to improving and maintaining residual cognitive and motor abilities in frail subjects in the chronic phase of the disease in the medium term. For this reason, a multicentre rehabilitation project will be developed that involves the use of innovative and integrated technological tools for both outpatient and asynchronous home rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 65 and 90 years;
- •Presence of chronic sensorimotor and/or cognitive disabilities;
- •Cognitive abilities that allow the patient to carry out simple orders and understand the physiotherapist's instructions [assessed using the Token Test (score ≥ 26.5)];
- •Ability to walk independently or with minimal assistance;
- •Ability to understand and sign the informed consent form.
排除标准
- •Presence of systemic, neurological, or cardiac conditions that make walking risky or cause motor deficits;
- •Oncological conditions, orthopedic or postural problems, presence of plantar ulcers;
- •Partial or total amputation of segments of the foot.
- •Inability to provide informed consent.
研究组 & 干预措施
Technological Group (G-Tec)
G-Tec patients will undergo outpatient technological rehabilitation treatment for 4 weeks using hunova® and Senso robots, followed by home-based technological rehabilitation treatment for another 4 weeks using a tablet with cognitive exercises developed specifically for home cognitive treatment, followed by 8 weeks of observation.
干预措施: Technological rehabilitation with robotic platfom and home telerehabilitation device (Device)
Conventional Group (G-Con)
G-Con patients will undergo conventional outpatient rehabilitation treatment for 4 weeks, followed by conventional home-based rehabilitation treatment, mainly cognitive in nature, for another 4 weeks, and then 8 weeks of observation.
干预措施: Conventional rehabilitation (Other)
结局指标
主要结局
Dual-Task Cost (DTC)
时间窗: Change from Baseline DTC at 8 weeks
DTC refers to the deterioration in performance in one or both tasks when two tasks are performed simultaneously compared to when they are performed individually. This cognitive cost manifests itself as a reduction in speed, accuracy or quality in task performance, and can be measured by comparing individual performance with that achieved in "dual task" mode. Specifically, DTC is calculated as the difference between the displacement of the centre of pressure during a cognitive task and the displacement of the centre of pressure during a single-task activity with eyes open, divided by the displacement of the centre of pressure during a single-task activity with eyes open. Higher DTC values correspond to a deterioration in performance.
次要结局
- Hand Grip Strength Test (HSGT)(Change from Baseline HGST at 8 weeks)
- Short Physical Performance Battery (SPPB)(Change from Baseline SPPB at 8 weeks)
- Stroop Colour Word Test (SCWT)(Change from Baseline SCWT at 8 weeks)
- Timed Up and Go Test (TUG)(Change from Baseline TUG at 8 weeks)
- Six-minute walk test (6MWT)(Change from Baseline 6MWT at 8 weeks)
- Timed-25 Foot Walk (T25FW)(Change from Baseline T25FW at 8 weeks)
- Silver Index (SI)(Change from Baseline SI at 8 weeks)
- Trial Making Test (TMT)(Change from Baseline TMT at 8 weeks)
- Symbol Digit Modalities Test (SDMT)(Change from Baseline SDMT at 8 weeks)
- Modified Fatigue Impact Scale (MFIS)(Change from Baseline MFIS at 8 weeks)
- EuroQoL- 5D (EQ-5D)(Change from Baseline EQ-5D at 8 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Change from Baseline HADS at 8 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Change from Baseline PSQI at 8 weeks)
- Bioimpedance analysis (BIA)(Change from Baseline BIA at 8 weeks)
- SARC-F(Change from Baseline SARC-F at 8 weeks)
- Mini Nutritional Assessment- short Form (MNA-SF)(Change from Baseline MNA-SF at 8 weeks)
研究者
GIOVANNINI SILVIA
Principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS