Neurorehabilitation Ecosystem for Sustained Therapy
Neurorehabilitation Ecosystem for Sustained Therapy (NEST): A Feasibility Study
This study is testing a new home rehabilitation system for stroke recovery to see how well it works and how people feel about using it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 2 sites (Ancona and 1 other locations) |
| Trial ID | NCT06219382 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate the usability, adherence, user experience, and acceptability of the Neurorehabilitation Ecosystem for Sustained Treatment (NEST) system, designed for home rehabilitation after stroke. Participants will engage with the system over a six-week intervention, and their feedback will be collected to enhance its design and functionality. The study will also assess the impact of the NEST system on arm hand function, impairment, and quality of life. Conducted across three clinical sites in Spain, Italy, and The Netherlands, the study will involve 5-10 subjects at each site to gather diverse insights.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 who have experienced a first-ever ischemic or hemorrhagic stroke with mild to moderate upper extremity motor impairment.
Not a fit: Patients with severe cognitive impairments or other significant health issues that could interfere with the study's execution may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective home rehabilitation solution that enhances recovery and quality of life for stroke patients.
How similar studies have performed: While there have been various technological approaches to stroke rehabilitation, this specific home-based ecosystem is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients presenting a first-ever ischemic or hemorrhagic stroke at least three months prior to study recruitment, confirmed by brain CT or MRI; 2. Mild to moderate motor impairment of the upper extremity (MRC ≥ 2) 3. Age = 18 - 80 years old; 4. Able to sit in a regular chair or wheelchair; 5. Experience with smartphone technology Exclusion Criteria: 1. The presence of a condition or abnormality that could compromise the patient's safety or data quality; 2. 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). 3. Arteriovenous malformation or other brain lesions not related to stroke; 4. Previous history of upper limb motor impairment 5. Sensory aphasia; 6. 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; 7. 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; 8. No experience with smartphone technology.
Where this trial is running
Ancona and 1 other locations
- Inrca — Ancona, Italy (Recruiting)
- Sint Maartenskliniek — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Susana Rodriguez, MD — Hospital Vall d'Hebron
- Study coordinator: Susana Rodriguez, MD
- Email: susana.rodriguezgonzalez@vallhebron.cat
- Phone: +34607609067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.