PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults

Study acronym: PhiCube-Adults
StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

  1. Minor Study First Submitted
This randomized controlled pilot trial evaluates the usability and safety of PhiCube, a compact, portable, bilateral end-effector robotic device for upper limb rehabilitation, and its impact on motor and cognitive function. Eighty adults aged 18 to 85 years are enrolled in two groups: 60 participants with neuromotor impairment of the upper limbs (stroke, amyotrophic lateral sclerosis, Parkinson's disease, spinal cord injury) and 20 participants with mild cognitive impairment. Within each group, participants are randomly assigned either to conventional rehabilitation combined with PhiCube training or to conventional rehabilitation alone, 5 days a week for 8 weeks. The primary endpoints are usability, measured with the System Usability Scale, and safety, measured as the incidence of adverse events reported by the participant or observed by the operator at the end of each session. Secondary endpoints address upper limb motor function, executive function, independence in daily activities, quality of life, adherence, satisfaction, perception of technology-assisted rehabilitation, and the effect of acoustic feedback on engagement and enjoyment.
Trial Details
NCT Number NCT07865260
Lead Sponsor Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
Collaborators: Istituti Clinici Scientifici Maugeri SpA, University of Pavia
Conditions
(from sponsor)
Stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Mild Cognitive Impairment, Upper Extremity Paresis
Related terms Amyotrophic Lateral Sclerosis, Cognitive Dysfunction, Paresis, Parkinson Disease, Spinal Cord Injuries, Stroke
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov