Digital Patient Engagement in Technology-Supported Neurorehabilitation

NCT07794072 | Not Yet Recruiting

• 1 other identifier: PSY-NeT-Engage-01
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Stroke; Parkinson Disease (PD); Motor Neuron Disease; Spinal Cord Injury; Traumatic Brain Injury; Neurological Disorders; Ataxia

Keywords

Neurorehabilitation; Digital patient engagement; Psychosocial factors; Robotic rehabilitation

Outcome Measures

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.

  At baseline, single assessment (Day 1)

Secondary Outcomes (3)

• Overall satisfaction with rehabilitation score assessed using the Overall Satisfaction with Rehabilitation Scale after completion of at least 3 rehabilitation sessions with the technologies

  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

  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

  At baseline, single assessment (Day 1)

Study Arms (1)

Patients Undergoing Technology-Supported Neurorehabilitation

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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.
• Have sufficient proficiency in Italian to understand the study information and complete the assessment measures reliably.
• Can use the digital tools required for data collection, e.g., a tablet, either independently or with compensatory aids and/or assistance from the data collection staff.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University, Italy: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator

Study Sites (3)

ICS Maugeri IRCCS - Istituto Scientifico di Milano

Milan, 20138, Italy

Location

ICS Maugeri IRCCS - Istituto Scientifico di Montescano

Montescano, Italy

Location

ICS Maugeri IRCCS - Istituto Scientifico di Pavia

Pavia, Italy

Location

Related Publications (20)

• Klaic M, Galea MP. Using the Technology Acceptance Model to Identify Factors That Predict Likelihood to Adopt Tele-Neurorehabilitation. Front Neurol. 2020 Dec 2;11:580832. doi: 10.3389/fneur.2020.580832. eCollection 2020.

  PMID: 33343488 BACKGROUND

• Warraich Z, Kleim JA. Neural plasticity: the biological substrate for neurorehabilitation. PM R. 2010 Dec;2(12 Suppl 2):S208-19. doi: 10.1016/j.pmrj.2010.10.016.

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• Danzl MM, Etter NM, Andreatta RD, Kitzman PH. Facilitating neurorehabilitation through principles of engagement. J Allied Health. 2012 Spring;41(1):35-41.

  PMID: 22544406 BACKGROUND

• Kelders SM, Kip H, Greeff J. Psychometric Evaluation of the TWente Engagement with Ehealth Technologies Scale (TWEETS): Evaluation Study. J Med Internet Res. 2020 Oct 9;22(10):e17757. doi: 10.2196/17757.

  PMID: 33021487 BACKGROUND

• Di Nitto M, Durante A, Torino F, Bolgeo T, Damico V, Ghizzardi G, Zerulo SR, Alvaro R, Vellone E, Biagioli V. Validity and Reliability of the Self-Care of Chronic Illness Inventory and Self-Care Self-Efficacy Scale in Patients Living With Cancer. J Adv Nurs. 2025 Dec;81(12):8620-8632. doi: 10.1111/jan.16823. Epub 2025 Feb 19.

  PMID: 39968728 BACKGROUND

• Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.

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• Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

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• Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

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• Fraser L, Burnell M, Salter LC, Fourkala EO, Kalsi J, Ryan A, Gessler S, Gidron Y, Steptoe A, Menon U. Identifying hopelessness in population research: a validation study of two brief measures of hopelessness. BMJ Open. 2014 May 30;4(5):e005093. doi: 10.1136/bmjopen-2014-005093.

  PMID: 24879829 BACKGROUND

• Andrich, R., Pedroni, F., & Vanni, G. (2003). Psychosocial impact of assistive devices: Italian localization of the PIADS instrument. Assistive Technology-Shaping the Future, GM Craddock, LP McCormack, RB Reilly, and HTP Knops, Eds, 917-921.

  BACKGROUND

• Yang, C., Wu, C. F., Wang, J., Chen, W. C., Chang, H., & Xu, D. D. (2024). A study on the intention of upper limb hemiplegic patients to use interactive gaming devices for hand rehabilitation. The Design Journal, 27(3), 470-492. https://doi.org/10.1080/14606925.2024.2334139

  BACKGROUND

• Venkatesh, V., Morris, M. G., Davis, G. B., & Davis, F. D. (2003). User Acceptance of Information Technology: Toward a Unified View. MIS Quarterly, 27(3), 425-478. https://doi.org/10.2307/30036540

  BACKGROUND

• Cressman, J. M., & Dawson, K. A. (2011). Evaluation of the Use of Healing Imagery in Athletic Injury Rehabilitation. Journal of Imagery Research in Sport and Physical Activity, 6(1). https://doi.org/10.2202/1932-0191.1060

  BACKGROUND

• Matamala-Gomez M, Maisto M, Montana JI, Mavrodiev PA, Baglio F, Rossetto F, Mantovani F, Riva G, Realdon O. The Role of Engagement in Teleneurorehabilitation: A Systematic Review. Front Neurol. 2020 May 6;11:354. doi: 10.3389/fneur.2020.00354. eCollection 2020.

  PMID: 32435227 BACKGROUND

• Zanatta F, Giardini A, Pierobon A, D'Addario M, Steca P. A systematic review on the usability of robotic and virtual reality devices in neuromotor rehabilitation: patients' and healthcare professionals' perspective. BMC Health Serv Res. 2022 Apr 20;22(1):523. doi: 10.1186/s12913-022-07821-w.

  PMID: 35443710 BACKGROUND

• Yu DS, De Maria M, Barbaranelli C, Vellone E, Matarese M, Ausili D, Rejane RE, Osokpo OH, Riegel B. Cross-cultural applicability of the Self-Care Self-Efficacy Scale in a multi-national study. J Adv Nurs. 2021 Feb;77(2):681-692. doi: 10.1111/jan.14617. Epub 2020 Dec 9.

  PMID: 33295675 BACKGROUND

• Wilson ML, Huggins-Manley AC, Ritzhaupt AD, Ruggles K. Development of the Abbreviated Technology Anxiety Scale (ATAS). Behav Res Methods. 2023 Jan;55(1):185-199. doi: 10.3758/s13428-022-01820-9. Epub 2022 Mar 25.

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• Day H, Jutai J, Campbell KA. Development of a scale to measure the psychosocial impact of assistive devices: lessons learned and the road ahead. Disabil Rehabil. 2002 Jan 10-Feb 15;24(1-3):31-7. doi: 10.1080/09638280110066343.

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• Rosa D, Villa G, Marcomini I, Nardin E, Gianfranceschi E, Faini A, Pengo MF, Bilo G, Croce A, Manara DF, Parati G. Psychometric Properties of the TWente Engagement with Ehealth Technologies Scale (TWEETS) Among Patients with Hypertension in Italy. High Blood Press Cardiovasc Prev. 2025 Jan;32(1):61-68. doi: 10.1007/s40292-024-00688-4. Epub 2024 Oct 29.

  PMID: 39472407 BACKGROUND

MeSH Terms

Conditions

Stroke; Parkinson Disease; Motor Neuron Disease; Spinal Cord Injuries; Brain Injuries, Traumatic; Nervous System Diseases; Ataxia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Craniocerebral Trauma; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrizia Catellani, PhD in Social Psychology

  Catholic University, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrizia Catellani, PhD in Social Psychology

CONTACT

393356741468; patrizia.catellani@unicatt.it

Valentina Carfora, PhD in Social Psychology

CONTACT

393338569908; valentina.carfora@unicatt.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)