PhiCube robotic device for arm and thinking rehabilitation in adults
Tests a portable robot for arm rehabilitation in adults with movement or thinking problems.
Key facts
- Who runs it
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
- Where
- Bari, Milan, Montescano, and Telese Terme, ItalySee the 4 sites
- Trial code
- Registry title
- PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults
- Status
- Not yet recruiting
- People taking part
- 80 people, planned
- Started
- Sept 2026
- Expected to end
- Sept 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- PhiCube
- Conventional rehabilitation
- Record updated
- 8 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with weakness or movement problems in the arms from stroke, ALS, Parkinson's disease or spinal cord injury, or with mild cognitive impairment. It tests a robotic arm rehabilitation device.
- Age
- 18 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Group 1: a movement disorder affecting the arms (stroke, amyotrophic lateral sclerosis, Parkinson's disease or spinal cord injury). Group 2: mild cognitive impairment with a MoCA score between 18 and 25.
Main reasons for not taking part
- Severe cognitive or behavioural problems (MoCA below 18)
- Severe arm weakness (MRC score below 3 in deltoid, biceps and triceps)
- Arm movement limits that cannot be changed or are painful
- Recent arm joint injury or joint prosthesis, shoulder dislocation risk, severe osteoporosis or severe muscle stiffness
- Unstable health conditions that make the robotic device unsafe, or another clinical trial in the last 30 days
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Italy
- Istituti Clinici Scientifici Maugeri IRCCS BariBari, ItalyContact: Stefania De Trane, MDNo longer taking part
- Istituti Clinici Scientifici Maugeri IRCCS, MilanoMilan, ItalyContact: Christian Lunetta, MDNo longer taking part
- Istituti Clinici Scientifici Maugeri IRCCS, MontescanoMontescano, ItalyContact: Cira Fundaro, MDNo longer taking part
- Istituti Clinici Scientifici Maugeri IRCCS, Telese TermeTelese Terme, ItalyContact: Laura Marcuccio, MDNo longer taking part
About the trial
What the trial wants to find out
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
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.
The 4 groups in the trial
- Group 1 neuromotor: PhiCube plus conventionalTreatment being tested
Thirty participants with neuromotor impairment of the upper limbs receive conventional rehabilitation combined with PhiCube training, 5 days a week for 8 weeks, each PhiCube session lasting 15 minutes of effective use.
Treatment: PhiCube and Conventional rehabilitation
- Group 1 neuromotor: conventional onlyExisting treatment, for comparison
Thirty participants with neuromotor impairment of the upper limbs receive conventional rehabilitation alone, 5 days a week for 8 weeks.
Treatment: Conventional rehabilitation
- Group 2 cognitive: PhiCube plus conventionalTreatment being tested
Ten participants with mild cognitive impairment receive conventional rehabilitation combined with PhiCube training, 5 days a week for 8 weeks, each PhiCube session lasting 15 minutes of effective use.
Treatment: PhiCube and Conventional rehabilitation
- Group 2 cognitive: conventional onlyExisting treatment, for comparison
Ten participants with mild cognitive impairment receive conventional rehabilitation alone, 5 days a week for 8 weeks.
Treatment: Conventional rehabilitation
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- PhiCube robotic device for arm and thinking rehabilitation in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07865260, who can take part
- Record updated
- 8 October 2026