NCT07865260Not yet recruiting
PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in 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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
- NCT number
- NCT07865260
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Sept 2026 to the primary completion date, 30 Sept 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial within the 30 days before enrolment
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituti Clinici Scientifici Maugeri IRCCS Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Istituti Clinici Scientifici Maugeri IRCCS, Milano Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituti Clinici Scientifici Maugeri IRCCS, Montescano Coordinator of this site? Confirm its status | Montescano | Italy | Unknown status |
| Istituti Clinici Scientifici Maugeri IRCCS, Telese Terme Coordinator of this site? Confirm its status | Telese Terme | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.