PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults
NCT07865260, Not applicable, Not yet recruiting, Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | PhiCube for Bilateral Upper Limb Neuromotor and Cognitive Rehabilitation in Adults | ClinicalTrials.gov |
| NCT number | NCT07865260 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato | ClinicalTrials.gov |
| Conditions | Stroke, Parkinson Disease, Amyotrophic Lateral Sclerosis, Spinal Cord Injuries, Mild Cognitive Impairment, Upper Extremity Paresis | ClinicalTrials.gov |
| Interventions | PhiCube, Conventional rehabilitation | ClinicalTrials.gov |
| First posted | 2026-10-08 | ClinicalTrials.gov |
| Last updated | 2026-10-08 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Usability of PhiCube measured with the System Usability Scale (SUS) | At the end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
| Primary | Incidence of adverse events | Throughout the 8-week treatment period, assessed at the end of each session | 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. | ClinicalTrials.gov |
| Secondary | Change in upper limb motor function measured with the Fugl-Meyer Assessment (FMA) | Baseline (T0) and end of the 8-week treatment period (T60) | Assessed in Group 1 (neuromotor impairment). The Fugl-Meyer Assessment evaluates upper limb motor function, sensation and balance; higher scores indicate better motor function. | ClinicalTrials.gov |
| Secondary | 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) | 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. | ClinicalTrials.gov |
| Secondary | Change in cognitive flexibility and inhibitory control measured with the Stroop test | Baseline (T0) and end of the 8-week treatment period (T60) | Assessed in Group 2 (cognitive impairment). Participants name the ink colour of colour words that may conflict with the meaning of the word. | ClinicalTrials.gov |
| Secondary | Change in visuospatial working memory measured with the Corsi Block-Tapping Test | Baseline (T0) and end of the 8-week treatment period (T60) | Assessed in Group 2 (cognitive impairment). Participants replicate sequences of block taps presented in random order; higher spans indicate better visuospatial working memory. | ClinicalTrials.gov |
| Secondary | Change in frontal lobe function measured with the Frontal Assessment Battery (FAB) | Baseline (T0) and end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
| Secondary | Change in independence in activities of daily living measured with the ADL Performance Assessment | Baseline (T0) and end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
| Secondary | Change in health-related quality of life measured with the EuroQol-5D (EQ-5D) | Baseline (T0) and end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
| Secondary | Adherence to the treatment regimen | Throughout the 8-week treatment period | Number of sessions attended out of those scheduled, together with documentation of any deviation or problem observed during the sessions. | ClinicalTrials.gov |
| Secondary | Participant satisfaction measured with the Patient Global Impression of Change (PGIC) | At the end of the 8-week treatment period (T60) | Subjective measure of the participant's overall perception of improvement or change in their condition after the intervention. | ClinicalTrials.gov |
| Secondary | Perception of technology-assisted rehabilitation measured with the TARPP-Q | At the end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
| Secondary | Visual Analogue Scale (VAS) for fun | Baseline (T0) and end of the 8-week treatment period (T60) | Subjective measurement of fun intensity. Values: \[Totally disagree; Neutral; Totally agree\] | ClinicalTrials.gov |
| Secondary | Visual Analogue Scale (VAS) for engagement | Baseline (T0) and end of the 8-week treatment period (T60) | Subjective measurement of engagement intensity. Values: \[Totally disagree; Neutral; Totally agree\] | ClinicalTrials.gov |
| Secondary | Game experience measured with an in-game questionnaire | Baseline (T0) and end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
| Other | Change in EEG indices of cognitive workload and engagement | Baseline (T0) and end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
| Other | Change in weight of connections between pairs of brain regions | Baseline (T0) and end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
| Other | Change in cortico-muscular coherence | Baseline (T0) and end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
| Other | Change in small-worldness of brain-body networks | Baseline (T0) and end of the 8-week treatment period (T60) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)