Neurorehabilitation Ecosystem for Sustained Therapy (NEST): A Feasibility Study
NCT06219382 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15
Last updated 2024-01-23
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
More Related Trials
-
Movement-activated Auricular Vagus Nerve Stimulation in Rehabilitation
NCT06623721 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Rehabilomics Study in Stroke Patients After Robotic Rehabilitation
NCT04223180 ·Status: COMPLETED
-
Determine the Effect of Targeted High-definition Transcranial Direct Current Stimulation (tDCS) on Reducing Post-stroke Upper Limb Motor Impairments
NCT05479006 ·Status: RECRUITING ·Phase: NA
-
Motor rECovery witH eArly imagiNg In STroke
NCT04165616 ·Status: RECRUITING
-
Non-invasive Neuromodulation NESA Application in the Rehabilitation of Stroke Sequelae
NCT05853952 ·Status: RECRUITING ·Phase: NA
-
AI-based Upper Limb Rehabilitation Therapy With MOTORE
NCT05238389 ·Status: COMPLETED ·Phase: NA
-
Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE)
NCT06212219 ·Status: RECRUITING ·Phase: NA
-
Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
NCT00142792 ·Status: COMPLETED ·Phase: NA
-
Mechanisms of Arm Recovery in Stroke Patients With Hand Paralysis
NCT03067818 ·Status: COMPLETED ·Phase: NA
-
Dry Needling in Stroke in Sub-Acute Phase to Improve Upper Limb
NCT03462693 ·Status: COMPLETED
-
Characterising the Neuromuscular Function of Post Stroke Patients
NCT07013188 ·Status: RECRUITING
-
BCI Driving FES and Hand Orthosis for Upper Limb Rehabilitation in Chronic Stroke
NCT06179745 ·Status: RECRUITING ·Phase: NA
-
A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke
NCT02637791 ·Status: COMPLETED ·Phase: PHASE1
-
MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke
NCT03323632 ·Status: UNKNOWN ·Phase: NA
-
Effect of Transcranial Magnetic Stimulation on Recovery of Upper Limb Among Stroke Survivors
NCT01938690 ·Status: COMPLETED ·Phase: NA
-
Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis
NCT00170716 ·Status: UNKNOWN ·Phase: PHASE3
-
Therapies for Recovery of Hand Function After Stroke
NCT03574623 ·Status: COMPLETED ·Phase: NA
-
A Novel Approach for Brain Stimulation in Severe Stroke
NCT03868410 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
Enhancing Plasticity in Stroke Patients With Severe Motor Deficit
NCT02633215 ·Status: COMPLETED ·Phase: NA
-
Wrist-worn Sensors for Tele-Rehabilitation of the Hemiparetic Upper Extremity
NCT03431025 ·Status: UNKNOWN ·Phase: NA
-
Peripheral Nerve Stimulation and Motor Training in Stroke
NCT02658578 ·Status: COMPLETED ·Phase: NA
-
Utility of CC7 Transfer in Stroke Subtypes
NCT06001736 ·Status: RECRUITING ·Phase: NA
-
Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients
NCT06928857 ·Status: RECRUITING ·Phase: NA
-
Transcranial Stimulation and Motor Training in Stroke Rehabilitation
NCT01414582 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Early Electrical Stimulation to Prevent Complications in the Arm Post-stroke - a Feasibility Study
NCT02324634 ·Status: UNKNOWN ·Phase: NA