PhiCube-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
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Italian Ministry of University and Research
interventional
80
1 country
4
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 7, 2026
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 8, 2026
Actual (reported)September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Usability of PhiCube measured with the System Usability Scale (SUS)
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.
At the end of the 8-week treatment period (T60)
Incidence of adverse events
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.
Throughout the 8-week treatment period, assessed at the end of each session
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.
Thirty participants with neuromotor impairment of the upper limbs receive conventional rehabilitation alone, 5 days a week for 8 weeks.
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.
Istituti Clinici Scientifici Maugeri IRCCS, Bari
Bari, 70124, Italy
Istituti Clinici Scientifici Maugeri IRCCS, Milano
Milan, 20138, Italy
Christian Lunetta, MD
Istituti Clinici Scientifici Maugeri IRCCS, Milano
First Submitted
August 7, 2026
First Posted
October 8, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients
Change in upper limb motor function measured with the Fugl-Meyer Assessment (FMA)
Baseline (T0) and end of the 8-week treatment period (T60)
Change in executive function measured with the Trail Making Test A and B (TMT)
Baseline (T0) and end of the 8-week treatment period (T60)
Change in cognitive flexibility and inhibitory control measured with the Stroop test
Baseline (T0) and end of the 8-week treatment period (T60)
Change in visuospatial working memory measured with the Corsi Block-Tapping Test
Baseline (T0) and end of the 8-week treatment period (T60)
Change in frontal lobe function measured with the Frontal Assessment Battery (FAB)
Baseline (T0) and end of the 8-week treatment period (T60)
Change in EEG indices of cognitive workload and engagement
Baseline (T0) and end of the 8-week treatment period (T60)
Change in weight of connections between pairs of brain regions
Baseline (T0) and end of the 8-week treatment period (T60)
Change in cortico-muscular coherence
Baseline (T0) and end of the 8-week treatment period (T60)
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.
Ten participants with mild cognitive impairment receive conventional rehabilitation alone, 5 days a week for 8 weeks.
Standard rehabilitation treatment delivered at the participating centers during ordinary hospitalization or outpatient rehabilitation, 5 days a week for 8 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Istituti Clinici Scientifici Maugeri IRCCS, Montescano
Montescano, 27040, Italy
Istituti Clinici Scientifici Maugeri IRCCS, Telese Terme
Telese Terme, 82037, Italy
Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: