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.
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
Adults aged 18 to 85 years
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
Parallel
PhiCube
DeviceBilateral, 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 rehabilitation
Other interventionStandard 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Università di Pavia
Collaborator
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