StrokePhiCube-AdultsNCT07865260
PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults
A study testing PhiCube and Conventional rehabilitation in people with Stroke and Parkinson Disease, run by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis
- What is being tested?
- PhiCube and Conventional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesItaly
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
- 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
- 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
- Participation in another clinical trial within the 30 days before enrolment
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christian Lunetta contact
Italy4 sites
Istituti Clinici Scientifici Maugeri IRCCS, Bari
Bari, 70124
Stefania De Trane, MD, stefania.detrane@icsmaugeri.it
Stefania De Trane, MD
Istituti Clinici Scientifici Maugeri IRCCS, Milano
Milan, 20138
Christian Lunetta, MD, christian.lunetta@icsmaugeri.it
Christian Lunetta, MD
Istituti Clinici Scientifici Maugeri IRCCS, Montescano
Montescano, 27040
Cira Fundaro, MD, cira.fundaro@icsmaugeri.it
Cira Fundaro, MD
Istituti Clinici Scientifici Maugeri IRCCS, Telese Terme
Telese Terme, 82037
Laura Marcuccio, MD, laura.marcuccio@icsmaugeri.it
Laura Marcuccio, MD
About this study
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
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.
Read the detailed description
Background and rationale
Neuromotor disorders such as stroke, Parkinson's disease and spinal cord injury frequently cause upper limb motor impairment, while mild cognitive impairment and dementia affect memory and executive function. Conventional rehabilitation requires specialized resources and may not sustain patient engagement over time. Most robotic devices for upper limb rehabilitation are unilateral, whereas bilateral training may increase primary motor cortex activation and interhemispheric communication.
PhiCube is a modular robotic device for bilateral upper limb rehabilitation. A central robotic body with two motorized rotary axes accepts interchangeable handles, allowing shoulder, elbow and wrist movements of both arms with a single compact and portable device. The motors can assist or resist movement according to residual mobility, and assistance can be delivered bilaterally so that the action of one limb supports the other. Two software modules are provided: RehabApp, used by the therapist to select exercises and set hardware and software parameters, and Dashboard, used to monitor performance. Data are stored on the device in encrypted form and can be exported as tables or reports.
Study design
Pilot randomized controlled study with parallel assignment. Participants are stratified into two diagnostic groups and randomized within each group by a simple randomization procedure to the experimental arm (PhiCube plus conventional rehabilitation) or to the control arm (conventional rehabilitation alone).
Group 1 (neuromotor impairment): 60 participants, 30 experimental and 30 control.
Group 2 (cognitive impairment): 20 participants, 10 experimental and 10 control.
Treatment
Participants in the experimental arms use PhiCube in addition to conventional rehabilitation for 8 weeks, 5 days per week, with each PhiCube session lasting 15 minutes of effective use. Control arms receive conventional rehabilitation alone for the same period. Alignment and training meetings and dedicated standard operating procedures ensure consistency across centers.
Assessments
Demographic data, medical history, comorbidities, medications, disease onset date and condition-specific data are collected at admission. Clinical scales are administered at baseline (T0) and at the end of treatment (T60).
Exploratory assessments
At the Milano and Telese centers only, and in 30 participants with chronic neuromotor impairment, synchronized multichannel EEG, surface EMG and single-lead ECG are acquired before (T0) and at the end (T60) of the rehabilitation program to investigate brain connectivity, cognitive workload, cortico-muscular correlation, muscle activation patterns and synergistic control.
- Conditions
- Stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Mild Cognitive Impairment, Upper Extremity Paresis
- Being tested
- PhiCube, Conventional rehabilitation
- Keywords
- Robotic rehabilitation, Bilateral upper limb training, End-effector robot, Usability, Exergames, Acoustic feedback, PhiCube
- Medical subject headings
- Stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Cognitive Dysfunction, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhiCubeDevice
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 rehabilitationOther
Standard rehabilitation treatment delivered at the participating centers during ordinary hospitalization or outpatient rehabilitation, 5 days a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 neuromotor: PhiCube plus conventional | Experimental | 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. Receives: Device: PhiCube; Other: Conventional rehabilitation |
| Group 1 neuromotor: conventional only | Active comparator | Thirty participants with neuromotor impairment of the upper limbs receive conventional rehabilitation alone, 5 days a week for 8 weeks. Receives: Other: Conventional rehabilitation |
| Group 2 cognitive: PhiCube plus conventional | Experimental | 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. Receives: Device: PhiCube; Other: Conventional rehabilitation |
| Group 2 cognitive: conventional only | Active comparator | Ten participants with mild cognitive impairment receive conventional rehabilitation alone, 5 days a week for 8 weeks. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Throughout the 8-week treatment period, assessed at the end of each session
Secondary outcomes (13)
Change in upper limb motor function measured with the Fugl-Meyer Assessment (FMA)
Assessed in Group 1 (neuromotor impairment). The Fugl-Meyer Assessment evaluates upper limb motor function, sensation and balance; higher scores indicate better motor function.
Measured: 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)
Assessed in Group 2 (cognitive impairment). Part A requires connecting consecutive numbers as quickly as possible; Part B requires alternating between numbers and letters in ascending order. Longer completion times indicate poorer performance.
Measured: Baseline (T0) and end of the 8-week treatment period (T60)
Change in cognitive flexibility and inhibitory control measured with the Stroop test
Assessed in Group 2 (cognitive impairment). Participants name the ink colour of colour words that may conflict with the meaning of the word.
Measured: Baseline (T0) and end of the 8-week treatment period (T60)
Change in visuospatial working memory measured with the Corsi Block-Tapping Test
Assessed in Group 2 (cognitive impairment). Participants replicate sequences of block taps presented in random order; higher spans indicate better visuospatial working memory.
Measured: Baseline (T0) and end of the 8-week treatment period (T60)
Change in frontal lobe function measured with the Frontal Assessment Battery (FAB)
Assessed in Group 2 (cognitive impairment). Brief screening tool of frontal lobe function covering attention, problem solving, cognitive flexibility, inhibitory control and motor programming; higher scores indicate better performance.
Measured: Baseline (T0) and end of the 8-week treatment period (T60)
Change in independence in activities of daily living measured with the ADL Performance Assessment
Assessed in both groups. Evaluation of the ability to perform activities of daily living such as dressing, eating and personal hygiene, as a measure of independence and functional capacity.
Measured: Baseline (T0) and end of the 8-week treatment period (T60)
Change in health-related quality of life measured with the EuroQol-5D (EQ-5D)
Assessed in both groups. Self-reported questionnaire covering mobility, self-care, usual activities, pain or discomfort and anxiety or depression, together with a visual analogue scale of overall health.
Measured: Baseline (T0) and end of the 8-week treatment period (T60)
Adherence to the treatment regimen
Number of sessions attended out of those scheduled, together with documentation of any deviation or problem observed during the sessions.
Measured: Throughout the 8-week treatment period
Participant satisfaction measured with the Patient Global Impression of Change (PGIC)
Subjective measure of the participant's overall perception of improvement or change in their condition after the intervention.
Measured: At the end of the 8-week treatment period (T60)
Perception of technology-assisted rehabilitation measured with the TARPP-Q
The Technology Assisted Rehabilitation Patient Perception Questionnaire evaluates the participant's perception and experience during technology-assisted training, including ease of learning, efficiency of use, usefulness of features and overall satisfaction.
Measured: At the end of the 8-week treatment period (T60)
Visual Analogue Scale (VAS) for fun
Subjective measurement of fun intensity. Values: [Totally disagree; Neutral; Totally agree]
Measured: Baseline (T0) and end of the 8-week treatment period (T60)
Visual Analogue Scale (VAS) for engagement
Subjective measurement of engagement intensity. Values: [Totally disagree; Neutral; Totally agree]
Measured: Baseline (T0) and end of the 8-week treatment period (T60)
Game experience measured with an in-game questionnaire
Self-report measure of the psychological and emotional aspects of the exergame experience, covering engagement, emotions, flow and satisfaction, complemented by spontaneous comments and by the game condition preferred during the rehabilitation program.
Measured: Baseline (T0) and end of the 8-week treatment period (T60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated to two diagnostic groups according to their clinical profile (neuromotor impairment or cognitive impairment) and are randomized within each group to conventional rehabilitation plus PhiCube training or to conventional rehabilitation alone, giving four parallel arms.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, University of Pavia
- Responsible party
- Sponsor
- Investigators
- Christian Lunetta, MD, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865260
- Sponsor's protocol ID
- PHICUBE-ADULTS
- Other IDs
- PNC0000007
- Acronym
- PhiCube-Adults
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided