No phaseNot yet recruitingAge-related condition
PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults (PhiCube-Adults)
A Randomized Controlled Trial to Evaluate the Usability, Safety and Impact of PhiCube in Bilateral Neuromotor Rehabilitation of the Upper Limbs and Cognitive Function in Individuals With Neuromotor and Cognitive Impairments
- Sponsor
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato (Academic or other)
- Enrolment
- 80 planned
- Conditions
- Stroke; Parkinson Disease; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Mild Cognitive Impairment; Upper Extremity Paresis
- Interventions
- PhiCube; Conventional rehabilitation
- Ages
- adults, older adults
- Registry
- NCT07865260
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Usability of PhiCube measured with the System Usability Scale (SUS)
- Incidence of adverse events
History
Primary completion expected
Registered
Started