Status:
RECRUITING
Neurorehabilitation Ecosystem for Sustained Therapy (NEST): A Feasibility Study
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsors:
Sint Maartenskliniek
NRCA - IRCCS Istituto Nazionale di Ricovero e Cura per Anziani
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
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 ...
Detailed Description
The main objective of the feasibility study is to assess 1) the usability, 2) adherence, 3) user experience and 4) acceptability of the NEST system during a six-week intervention. In particular, Inves...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06219382
Start Date
January 15 2023
End Date
April 30 2024
Last Update
January 23 2024
Active Locations (2)
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1
INRCA
Ancona, Italy
2
Sint Maartenskliniek
Nijmegen, Netherlands