PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults
Key facts
- Where
- Bari, Milan, Montescano, and Telese Terme, ItalySee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07865260, who can take part
Where in Italy
- Istituti Clinici Scientifici Maugeri IRCCS BariBari, ItalyNo longer taking part
- Istituti Clinici Scientifici Maugeri IRCCS, MilanoMilan, ItalyNo longer taking part
- Istituti Clinici Scientifici Maugeri IRCCS, MontescanoMontescano, ItalyNo longer taking part
- Istituti Clinici Scientifici Maugeri IRCCS, Telese TermeTelese Terme, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
- Trial code
- NCT07865260
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Group 1 (neuromotor impairment):; Adults aged 18 to 85 years; Diagnosis of a neuromotor disorder affecting the upper limbs, such as stroke, amyotrophic lateral sclerosis, Parkinson's disease or spinal cord injury; Able to provide informed consent; Group 2 (cognitive impairment):; Adults aged 18 to 85 years; Diagnosis of mild cognitive impairment defined by a MoCA score between 18 and 25; Able to provide informed consent.
Exclusion: Participation in another clinical trial within the 30 days before enrolment; Severe cognitive or behavioural impairment (MoCA below 18); Severe upper limb motor impairment, defined as an MRC score below 3 in deltoid, biceps and triceps; Impairment of upper limb range of motion that is non-modifiable or painful; Contraindications to robotic therapy, that is unstable health conditions that could make the use of the device dangerous or inappropriate, such as severe cardiovascular disease, severe respiratory disease or other unstable medical conditions; Recent upper limb joint injury or joint prosthesis, risk of shoulder dislocation (for example shoulder subluxation), severe osteoporosis, or severe spastic hypertonia of elbow and wrist flexors according to medical judgement.