NCT06219382: NEST

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

Status unknown Last updated 23 January 2024

What this trial tests

trial testing Neurorehabilitation ecosystem in Stroke in 15 participants. Status unknown.

Timeline

15 January 2023

Primary endpoint
30 April 2024

30 April 2024

Quick facts

Lead sponsor	Hospital Universitari Vall d'Hebron Research Institute
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	15
Start date	15 January 2023
Primary completion	30 April 2024
Estimated completion	30 April 2024
Sites	2 locations across Italy, Netherlands

Drugs / interventions tested

• Neurorehabilitation ecosystem

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Who can join

Adults 18 to 80, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.