An interventional study of PhiCube and Conventional rehabilitation in Stroke, Parkinson Disease and Amyotrophic Lateral Sclerosis, sponsored by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato. Not yet recruiting at 4 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Group 1 (neuromotor impairment):
Group 2 (cognitive impairment):
Exclusion Criteria (both groups):
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.
Device: PhiCube · Other: Conventional rehabilitation
Thirty participants with neuromotor impairment of the upper limbs receive conventional rehabilitation alone, 5 days a week for 8 weeks.
Other: Conventional rehabilitation
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.
Device: PhiCube · Other: Conventional rehabilitation
Ten participants with mild cognitive impairment receive conventional rehabilitation alone, 5 days a week for 8 weeks.
Other: Conventional rehabilitation
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.
Standard rehabilitation treatment delivered at the participating centers during ordinary hospitalization or outpatient rehabilitation, 5 days a week for 8 weeks.
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.
Time frame: 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.
Time frame: Throughout the 8-week treatment period, assessed at the end of each session
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the end of the 8-week treatment period (T60)
Visual Analogue Scale (VAS) for fun
Subjective measurement of fun intensity. Values: \[Totally disagree; Neutral; Totally agree\]
Time frame: Baseline (T0) and end of the 8-week treatment period (T60)
Visual Analogue Scale (VAS) for engagement
Subjective measurement of engagement intensity. Values: \[Totally disagree; Neutral; Totally agree\]
Time frame: 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.
Time frame: Baseline (T0) and end of the 8-week treatment period (T60)
Change in EEG indices of cognitive workload and engagement
Assessed in 30 patients from Group 1. Multichannel EEG signals are employed to explore regional and frequency-specific changes in EEG power during motor tasks and to quantify EEG-derived power ratio indices of cognitive workload and engagement during motor task execution. The former is obtained by calculating the ratio between the EEG power in the theta and alpha bands evaluated in the frontal and parietal regions, respectively. The latter is obtained by calculating the ratio between the EEG power in the beta and (alpha+theta) bands averaged in the central and parietal regions. Higher values of cognitive workload are indicative of a higher mental demand during motor execution, while higher values of engagement are indicative of a greater involvement.
Time frame: Baseline (T0) and end of the 8-week treatment period (T60)
Change in weight of connections between pairs of brain regions
Assessed in 30 patients from Group 1. Multichannel EEG signals are employed to assess changes in the functional and effective connectivity across brain regions, respectively evaluated through coupling and causality measures, both at rest and during motor tasks. The coherence measure is employed to evaluate the strength of a linear relationship between the dynamics of two brain regions, while the Granger causality measure is employed to assess the enhancement in predictability of the dynamics of a brain region when another is known, thereby pointing to causal dynamics. Higher values of both these measures are indicative of stronger weight of the connections, and thus of stronger coupling/causal dynamics between pairs of brain regions.
Time frame: Baseline (T0) and end of the 8-week treatment period (T60)
Change in cortico-muscular coherence
Assessed in 30 patients from Group 1. Multichannel EEG and surface EMG signals are employed to evaluate the linear frequency-specific correlations between neural signals and muscle activity during motor tasks by employing coherence measures. Higher values of cortico-muscular coherence are indicative of stronger communication and synchronisation between cortical and muscular dynamics.
Time frame: Baseline (T0) and end of the 8-week treatment period (T60)
Change in small-worldness of brain-body networks
Description: Assessed in 30 patients from Group 1. Synchronized multichannel EEG, surface EMG and single-lead ECG are employed to evaluate the interaction between the central nervous system, the autonomic nervous system and the muscular system. Brain-body networks are characterized via the graph theory index of small-worldness, computed as the ratio of clustering coefficient and path length indices. As these two measures are indicative of network integration and segregation respectively, the small-worldness is an index of the balance between network structurality and randomness.
Time frame: Baseline (T0) and end of the 8-week treatment period (T60)
Plan to share: Undecided
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Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato