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

NCT06219382 | Unknown

• 1 other identifier: PR(AT)463/2023
• Study Type: observational
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief 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

Stroke

Outcome Measures

Primary Outcomes (4)

• Usability

  Usability will be assessed by the System Usability Scale (SUS), (Brooke J., 1996). Scores range between 0-100, low scores mean the device is not acceptable by users and higher scores mean good acceptance by users

  Week 6

• User experience

  User experience will be assessed by the User Experience Questionnaire (UEQ), (Laugwitz et al., 2008). Scores range (26-182), low scores mean the device is not attractive to users users and higher scores mean the product is very attractive to users.

  Week 6

• Adherence

  Adherence will be assessed by the total time the RGSapp is used, in comparison to the advised dosage, (via the user ID is possible to monitor the patient's access to the RGSapp and the hours trained), for the entire duration of the study.

  Week 6

• Acceptance

  .Acceptance will be assessed by the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0), (Demers, L. et al., 2000). Scores range (0-100), low scores mean bad quality of movement performed by the user and higher scores mean good quality of movement performed by the user.

  Week 6

Secondary Outcomes (7)

• Attitude towards the system

  Day 0, Week 6

• Fugl Meyer assessment motor score

  Day 0, Week 6

• Barthel Index

  Day 0, Week 6

• Modified Ashworth Scale

  Day 0, Week 6

• Fatigue Severity Scale

  Day 0, Week 6

Study Arms (1)

Neurorehabilitation ecosystem (NEST)

Patients will use Nest apart from the regular neurorehabilitation treatment

Device: Neurorehabilitation ecosystem

Interventions

Neurorehabilitation ecosystem DEVICE

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

Neurorehabilitation ecosystem (NEST)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with upper limb paresia secondary to a first-ever ischemic or hemorrhagic stroke at least three months prior to study recruitment, confirmed by brain CT or MRI

You may qualify if:

• 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

You may not qualify if:

• The presence of a condition or abnormality that could compromise the patient's safety or data quality;
• Severe cognitive impairments that prevent the execution of the experiment (MoCA \< 19). This cut-off point is based on a pilot study (Maier, M. et al., 2019).
• Arteriovenous malformation or other brain lesions not related to stroke;
• Previous history of upper limb motor impairment
• Sensory aphasia;
• Associated impairments: spasticity of the upper limb (Modified Ashworth scale≥ 3), apraxia, major pain, or other impairments that would interfere with the correct execution of the experiment;
• The NEST system cannot be used independently according to the therapist's observations and there is no available support from a caregiver to help use the system;
• No experience with smartphone technology.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Sint Maartenskliniek: collaborator
• NRCA - IRCCS Istituto Nazionale di Ricovero e Cura per Anziani: collaborator

Study Sites (2)

INRCA

Ancona, Italy

RECRUITING

Sint Maartenskliniek

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Susana Rodriguez, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susana Rodriguez, MD

CONTACT

+34607609067; susana.rodriguezgonzalez@vallhebron.cat

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 23, 2024
• Study Start: January 15, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

IT (1); NL (1)