An observational study in Stroke, Parkinson Disease (PD) and Motor Neuron Disease, sponsored by Catholic University, Italy. Not yet recruiting at 3 sites in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Catholic University, Italy · Observational
The goal of this observational study is to investigate digital patient engagement and its psychosocial correlates and potential predictors among adults aged 18-85 years with neurological disorders who are undergoing technology-supported neurorehabilitation using robotic systems for upper-limb training and/or virtual reality-based technologies.
Specifically, the study will examine the roles of hope and the quality of the patient-healthcare professional relationship as the potential predictors of engagement with rehabilitation technologies. It will also explore the contribution of disease-management self-efficacy, technology anxiety, and sociodemographic, clinical, functional, and rehabilitation-related characteristics. Finally, the study will examine whether digital patient engagement predicts the perceived psychosocial impact of rehabilitation technologies, behavioural intention to continue using them, and overall satisfaction with the rehabilitation pathway.
Participants will:
No experimental intervention, comparison group, or follow-up assessment is planned.
PSY-NeT-Engage is an academic, non-profit, multicentre, cross-sectional observational study designed to characterize digital patient engagement during technology-supported neurorehabilitation and to examine factors associated with differences in engagement. The study will be conducted among patients already receiving standard neurorehabilitation involving robotic systems for upper-limb training and/or virtual reality-based rehabilitation technologies at participating clinical centres. It will not assess the clinical or therapeutic efficacy of these technologies, functional recovery, or the achievement of rehabilitation goals, nor will it introduce any experimental intervention or modification to the standard rehabilitation pathway. Because the data will be collected cross-sectionally, the findings will be interpreted as exploratory associations and predictive relationships within the specified statistical models.
Data will be collected once for each participant during the standard neurorehabilitation pathway, after the participant has completed at least three rehabilitation sessions using the technologies under study. Consequently, participants may be assessed at different stages of rehabilitation and after completing different numbers of technology-supported sessions.
Patient-reported data will be collected through a single computerized self-report questionnaire administered via the Qualtrics digital platform using a password-protected tablet. Questionnaire completion is expected to require approximately 15 minutes. Research staff will be available to provide procedural clarification and technical assistance without influencing participants' responses. Relevant sociodemographic, clinical, functional, and rehabilitation-related variables will be extracted from clinical documentation. Variables not available in the clinical records will be collected directly from participants. No follow-up assessment is planned.
In addition to the primary outcome measure of digital patient engagement, the study includes secondary outcome measures of overall satisfaction with the rehabilitation pathway, behavioural intention to continue using rehabilitation technologies, and the perceived psychosocial impact of rehabilitation technologies. Four other pre-specified exploratory variables will also be assessed: hope, perceived quality of the patient-healthcare professional relationship, technology anxiety, and disease-management self-efficacy. These variables will be examined as potential psychosocial, relational, and individual predictors of digital patient engagement. Disease-management self-efficacy will be evaluated as a potential moderator.
Hope will be assessed using the 2-item Brief Hopelessness Scale with Positive Valence (Brief-H-Pos), which measures positive expectations regarding the future and the perceived attainability of personal goals. Higher scores indicate greater hope.
The perceived quality of the patient-healthcare professional relationship will be assessed using the 8-item Nordic Patient Experiences Questionnaire (NORPEQ). The questionnaire evaluates relevant dimensions of the patient's care experience, including communication with healthcare professionals, perceived care and attention, and trust in the healthcare team. Higher scores indicate a more positive care experience and better perceived relationship quality.
Technology anxiety will be assessed using the 11-item Abbreviated Technology Anxiety Scale (ATAS), which evaluates negative affective responses to technology, including apprehension, confidence, and perceived competence in using technological tools. Higher scores indicate greater technology anxiety.
Disease-management self-efficacy will be assessed using the 10-item Self-Efficacy Self-Care Scale (SCSES), which evaluates participants' confidence in their ability to maintain their health, monitor their condition, and manage symptoms while living with a chronic condition. Higher scores indicate greater disease-management self-efficacy. This variable will be examined as a secondary individual exposure factor and as a potential moderator of the associations between hope, the patient-healthcare professional relationship, and digital patient engagement.
For measures without an available validated Italian version, a research-specific Italian translation will be developed using forward-backward translation followed by review by an expert panel. The translated measures and data-collection procedures will initially be piloted in a subgroup of 15 participants to assess item comprehensibility and the adequacy of questionnaire administration. These translations are intended exclusively for research use and will not constitute validated instruments for routine clinical practice.
The minimum target sample of 129 participants was established through an a priori power analysis for structural equation modelling, assuming a moderate effect size of 0.30, statistical power of 0.80, and a two-sided significance level of α = 0.05. Consecutive non-probability sampling will be used, and data collection may continue beyond the minimum target throughout the planned recruitment period to improve the robustness and generalizability of the findings.
The statistical analysis will include descriptive statistics, assessment of variable distributions and outliers, and evaluation of internal consistency using Cronbach's alpha. Exploratory factor analysis will be used to examine the factor structure of measures without a validated Italian version. Initial associations will be evaluated using Pearson or Spearman correlation coefficients, as appropriate. Structural equation modelling will be applied within a confirmatory-exploratory framework to examine the plausibility, direction, and magnitude of the hypothesized direct, indirect, and total associations. Exploratory moderation analyses will be conducted using regression-based interaction models, and multiple regression models will be used to examine additional associations specified in the protocol. Robust estimators will be considered when non-normality or influential outliers could materially affect the results.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 129 is below the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →Catholic University, Italy is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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The study population is adult patients who, from the study start date at each participating ICS Maugeri centre, are enrolled under ordinary inpatient admission, simple outpatient care, or MAC (Macroattività Ambulatoriale Complessa; Complex Outpatient Macro-Activity), in a neurorehabilitation programme involving the support and use of robotic systems for upper-limb rehabilitation training (Gloreha BTL Robotics, Motore Humanware) and/or virtual reality-based rehabilitation technologies (VRRS Khymeia, Prokin Tecnobody).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with neurological disorders undergoing standard neurorehabilitation involving upper-limb robotic rehabilitation systems and/or virtual reality-based rehabilitation technologies at participating ICS Maugeri centres.
Digital patient engagement score assessed using the TWente Engagement with Ehealth Technologies Scale after completion of at least 3 rehabilitation sessions with the technologies
Digital patient engagement in the use of neurorehabilitation technologies will be measured using the TWente Engagement with Ehealth Technologies Scale (TWEETS), a 9-item self-report scale assessing cognitive, emotional, and behavioral engagement with eHealth technologies. Items are rated on a 4-point Likert scale from 1 = strongly disagree to 4 = strongly agree. A total score is calculated by summing the 9 items, with possible scores ranging from 9 to 36. Higher scores indicate higher digital patient engagement. "Not applicable" responses, if selected, are treated as missing and handled according to the pre-specified scoring plan.
Time frame: At baseline, single assessment (Day 1)
Overall satisfaction with rehabilitation score assessed using the Overall Satisfaction with Rehabilitation Scale after completion of at least 3 rehabilitation sessions with the technologies
Overall satisfaction with the rehabilitation pathway will be assessed using the Overall Satisfaction with Rehabilitation Scale (OSWRS), a 5-item self-report measure assessing global patient satisfaction with rehabilitation, including perceived progress, satisfaction with recovery timing, affective response to rehabilitation, and overall satisfaction. Items are rated on a 7-point Likert scale from 1 = strongly disagree to 7 = strongly agree. A total score is calculated by summing the 5 items, with possible scores ranging from 5 to 35. Higher scores indicate higher overall satisfaction with the rehabilitation pathway.
Time frame: At baseline, single assessment (Day 1)
Behavioral intention to continue using rehabilitation technologies score assessed using adapted UTAUT items after completion of at least 3 rehabilitation sessions with the technologies
Behavioral intention to continue using rehabilitation technologies will be assessed using 3 items adapted from the Unified Theory of Acceptance and Use of Technology (UTAUT). The items assess the participant's intention and planning to continue using the rehabilitation technologies in the near future. Items are rated on a 7-point Likert scale from 1 = strongly disagree to 7 = strongly agree. A total score is calculated by summing the 3 items, with possible scores ranging from 3 to 21. Higher scores indicate stronger behavioral intention to continue using rehabilitation technologies.
Time frame: At baseline, single assessment (Day 1)
Perceived psychosocial impact of rehabilitation technologies score assessed using the Psychosocial Impact of Assistive Devices Scale short form after completion of at least 3 rehabilitation sessions with the technologies
The perceived psychosocial impact of rehabilitation technologies will be measured using the short version of the Psychosocial Impact of Assistive Devices Scale (PIADS-10). The scale includes 10 items assessing the perceived impact of the device on competence, adaptability, and self-esteem. Items are rated on a 7-point scale from -3 = has decreased to +3 = has increased. A total score is calculated by summing the 10 items, with possible scores ranging from -30 to +30. Higher positive scores indicate greater perceived positive psychosocial impact of the rehabilitation technologies, while negative scores indicate perceived negative psychosocial impact.
Time frame: At baseline, single assessment (Day 1)
Plan to share: No — Individual participant data will not be shared because the study involves clinical and psychosocial data from a vulnerable neurological rehabilitation population. Data will be processed in pseudonymized/anonymized form, and access will be limited to authorized study personnel in accordance with the approved protocol and applicable data protection regulations.
Start is estimated for Oct 2026; primary completion for Jul 2027, 9 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Catholic University, Italy