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PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults
Sponsor: Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-09
Completion Date
2027-09
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
PhiCube
Bilateral, portable end-effector robotic device for upper limb rehabilitation, consisting of a central robotic body with two motorized rotary axes and interchangeable handles allowing shoulder, elbow and wrist movements of both arms. The motors assist or resist movement according to residual mobility. Therapy is delivered through exergames whose difficulty, level of robotic assistance and cognitive load are set by the therapist through the RehabApp software; performance is monitored through the Dashboard software. Sessions last 15 minutes of effective use, 5 days a week for 8 weeks, in addition to conventional rehabilitation. Three acoustic feedback conditions are available: no sound feedback, reward sound feedback on goal achievement, and directional or rhythmic sound feedback.
Conventional rehabilitation
Standard rehabilitation treatment delivered at the participating centers during ordinary hospitalization or outpatient rehabilitation, 5 days a week for 8 weeks.
Locations (4)
Istituti Clinici Scientifici Maugeri IRCCS, Bari
Bari, Italy
Istituti Clinici Scientifici Maugeri IRCCS, Milano
Milan, Italy
Istituti Clinici Scientifici Maugeri IRCCS, Montescano
Montescano, Italy
Istituti Clinici Scientifici Maugeri IRCCS, Telese Terme
Telese Terme, Italy