PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Usability of PhiCube measured with the System Usability Scale (SUS) — At the end of the 8-week treatment period (T60)
  The System Usability Scale is a 10-item questionnaire rated on a 5-point Likert scale from strongly disagree to strongly agree. The total score ranges from 0 to 100, with higher scores indicating better perceived usability. Administered to participants in the experimental arms after the last PhiCube session.
• Incidence of adverse events — Throughout the 8-week treatment period, assessed at the end of each session
  Number and frequency of adverse events reported by the participant or detected by the operator at the end of each rehabilitation session and recorded on a dedicated form.

Trial sites (4)

More Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato trials in Italy

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