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NCT07698405
Effects of Using Advanced NEUROrehabilitation TECHnologies in Upper Limb Motor Function and Capacity Recovery in People With Stroke
Conditions: Stroke
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 25
Sponsor: Azienda Unita Sanitaria Locale di Piacenza
Location: Fiorenzuola d'Arda Hospital - AUSL Piacenza Fiorenzuola d'Arda Piacenza
Summary
This study aims to evaluate the effect of a personalized technology-based rehabilitative intervention on Upper Limb (UL) motor function and capacity recovery in People with Stroke (PwS). The study is single-cohort study in which eligible participants will undergo baseline and follow-up clinical and instrumental assessments over a 4-5 week period.
The intervention consists of a personalized and specific upper limb technology-based rehabilitation programme delivered three times per week for a total of 12-15 sessions. Each session lasts approximately one hour and is integrated with conventional rehabilitation treatments.
Primary outcomes include Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT). Secondary outcomes include instrumental assessment of active range of motion and grip strength.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years;
* First-ever unilateral ischemic or hemorrhagic stroke;
* Presence of upper limb motor impairment;
* Modified Ashworth Scale (MAS) \< 3;
* Montreal Cognitive Assessment (MoCA) \> 24;
* Medically stable and able to participate in an intensive rehabilitation programme;
* Ability to understand and follow study procedures;
* Written informed consent.
Exclusion Criteria:
* Diagnosis of severe aphasia, based on medical records, preventing participation;
* Bilateral hemisphere lesions;
* Severe and unstable medical conditions (e.g. untreated seizure, heart failure) that preclude participation in rehabilitation;
* Other neurological and/or psychiatric diseases;
* Recent and unstabilized upper limb fracture.
Source: ClinicalTrials.gov (NCT07698405). StuddyBuddy aggregates publicly available trial information.