Neurorehabilitation Ecosystem for Sustained Therapy (NEST): A Feasibility Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

The global burden of stroke is staggering, with over 15M new cases reported annually. Of these cases, around 40% require motor and cognitive rehabilitation, resulting in approximately 6M new patients requiring treatment each year, in addition to the more than 33M chronic patients worldwide. This massive incidence puts great pressure on healthcare systems and mounting costs. Consequently, there is an urgent need for patient-specific solutions that maximize rehabilitation efficiency and improve the patient´s performance, activities of daily living (ADLs), and quality of life. While several technological solutions have been proposed for stroke recovery during hospitalization, there is a notable lack of attention to home rehabilitation, which is crucial for long-term recovery, cost reduction and minimizing the demand for rehabilitation personnel. Investigators propose NEST, the Neurorehabilitation Ecosystem for Sustained Treatment based on the Rehabilitation Gaming System (RGS), an advanced digital rehabilitation program that uses serious gaming and Augmented Reality (AR)- and Virtual Reality VR-based training and is grounded on neuroscientific principles, that has been shown to promote motor recovery after stroke at the clinic and at home (Ballester et al., 2017; Ballester et al., 2019). NEST uses a patient's user model solution interfaced via a novel digital and portable technology to provide a home rehabilitation program accepted by the patients and clinicians. The NEST system integrates the following components: * RGS-wear advances a multimodal unobtrusive wearable interface starting from the state-of-the-art wearable technologies including off-the-shelf wearables for the detection of arm activity. This data is sent through Bluetooth to a paired smartphone, which allows for the filtering of body movements. * The RGS-Mobile App (smartphones) communicates with the RGS-wear and integrates sensor data for the delivery of patient-tailored Augmented Reality AR-based exercises for motor and cognitive training, customized feedback via the AWA coach, and activity reports through the MIMS. * The AWA Coach (Agent for Wellbeing Assistance) which provides specific feedback based on the performance and the status of well-being of the user. The user can access information through the AWA Coach dashboard (AWAtar App), which is an interface that reports their performance. and progress. It also provides the user with direct and motivational feedback and training activities in order to assist them in acting when needed. \- MIMS (Medical Information Management System) is a cloud service in which relevant information on the patient's state is uploaded, allowing the monitoring of progress and the customization of the RGS-based training and evaluation protocols. Guaranteeing the correct use of this NEST ecosystem by post-stroke patients performing upper limb telerehabilitation implies conducting an usability study to measure its usability, adherence, acceptance and the user's experience. Investigators will also explore effectiveness of the NEST ecosystem in improving motor function of the paretic arm after stroke. Furthermore, uncovering end-user's experiences with NEST in an international multi-centre study should give valuable information into improving its features for a future clinical trial focusing on the effectiveness of the NEST system. This multicenter study will follow a mixed methods approach (quantitative and qualitative measurements).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients presenting a first-ever ischemic or hemorrhagic stroke at least three months prior to study recruitment, confirmed by brain CT or MRI;

• Mild to moderate motor impairment of the upper extremity (MRC ≥ 2)

• Age = 18 - 80 years old;

• Able to sit in a regular chair or wheelchair;

• Experience with smartphone technology

Locations
Other Locations
Italy
INRCA
RECRUITING
Ancona
Netherlands
Sint Maartenskliniek
RECRUITING
Nijmegen
Contact Information
Primary
Susana Rodriguez, MD
susana.rodriguezgonzalez@vallhebron.cat
+34607609067
Time Frame
Start Date: 2023-01-15
Estimated Completion Date: 2024-04-30
Participants
Target number of participants: 15
Treatments
Neurorehabilitation ecosystem (NEST)
Patients will use Nest apart from the regular neurorehabilitation treatment
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitari Vall d'Hebron Research Institute
Collaborators: NRCA - IRCCS Istituto Nazionale di Ricovero e Cura per Anziani, Sint Maartenskliniek

This content was sourced from clinicaltrials.gov