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

NCT06219382 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2024-01-23

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

Neurorehabilitation ecosystem

Over a period of six weeks, the participants will integrate the NEST system into their daily routines, running parallel to their regular neurorehabilitation treatment.

Sponsors & Collaborators

  • Sint Maartenskliniek

    collaborator OTHER
  • NRCA - IRCCS Istituto Nazionale di Ricovero e Cura per Anziani

    collaborator UNKNOWN
  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Susana Rodriguez, MD · Hospital Vall d'Hebron

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Italy
  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06219382 on ClinicalTrials.gov