Digital Patient Engagement in Technology-Supported Neurorehabilitation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorCatholic University, Italy

About this trial

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:

* continue their standard neurorehabilitation pathway without any modification to routine clinical procedures; * complete a computerized self-report questionnaire via the Qualtrics digital platform at a single time point after completing at least three rehabilitation sessions using the technologies under study.

No experimental intervention, comparison group, or follow-up assessment is planned.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 18 and 85 years.

Diagnosed with one of the following neurological conditions: stroke, Parkinson's disease, ataxia, motor neuron disease, spinal cord injury, traumatic brain injury, or post-neurosurgical neurological outcomes.

Have completed at least three rehabilitation sessions using the technologies under study, representing the minimum exposure required for participants to become sufficiently familiar with the technology and to provide informed feedback on their experience of use.

Have adequate cognitive functioning, defined as the ability to understand study-related information, provide informed consent, and reliably complete the planned assessment measures, as determined by the clinical team during routine clinical evaluation.

Disqualifiers

Diagnosis of an acute or non-stabilized psychiatric disorder, such as an active psychotic episode or a depressive episode with severe symptoms, that may interfere with informed participation in the study.

Severe uncompensated sensory impairment, such as severe visual or hearing impairment, that prevents the use of the digital tools required for data collection.

Motor impairment that prevents interaction with a tablet, even with compensatory aids and/or assistance from the data collection staff.

Trial population

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).

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

129 Participants
are grouped into 1 trial group
Group A: Patients Undergoing Technology-Supported Neurorehabilitation

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

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)
2

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)
3

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)

Other outcomes

Sponsors and contacts

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Catholic University, Italy

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborator

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