Improving rehabilitation for post-stroke patients using technology

Users' Experience and Cognitive Improvement in High-technology Rehabilitation Programs for Post-stroke Patients: a Multi-method, Multi-informant, Patient-centred Approach

This study is testing whether using technology like robotics and virtual reality can help post-stroke patients recover better than traditional rehab methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Milano Bicocca (other)
• Locations: 1 site (Milan)
• Trial ID: NCT06489145 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of technology-enhanced rehabilitation programs, including robotics and virtual reality, for post-stroke patients. It consists of two parallel studies: one focusing on patient outcomes such as motor function, cognition, and quality of life, and the other exploring the experiences of caregivers and therapists involved in the rehabilitation process. The study aims to compare these technology-enhanced methods with traditional rehabilitation approaches and assess the usability and acceptability of the devices used. Additionally, therapists will participate in focus groups to discuss barriers and facilitators to implementing these technologies in rehabilitation.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 who have experienced an acute stroke within the last 12 months and have manageable levels of motor impairment.

Not a fit: Patients with severe cognitive impairments or complete upper limb hemiplegia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly enhance the rehabilitation outcomes and quality of life for post-stroke patients.

How similar studies have performed: Other studies have shown promising results with technology-enhanced rehabilitation approaches, suggesting potential for success in this study as well.

Eligibility criteria

Study 1 (ID: 0025654/24)

Patients

Inclusion Criteria:

* Acute stroke event occurring within a maximum of 12 months prior to treatment;
* Age over 18 years;
* Acceptable hyposthenia evaluated with the Motricity Index (scores less than the maximum)
* Spasticity, if present, compatible with limb function (MAS score \< 2)
* Mental health condition allowing for a full understanding of the study objectives and completion of self-report measures

Exclusion Criteria:

* Severe clinical condition (e.g., cognitive impairment - MMSE score \< 24), presence of sever apraxia, complete upper limbs hemiplegia, severe upper limb sensory disorders, joint fractures and dislocations);
* clinical non-eligibility to the use of exoskeleton devices as per technical specifications of the devices
* Inability or difficulty in completing self-report measures in Italian and/or secondary illiteracy;
* Presence of psychiatric pathology in medical history or recent psychiatric pathology that could affect reliability of data collected;
* Refusal or withdrawal of informed consent at any stage of the study.

Caregivers

Inclusion Criteria:

* Any informal caregiver (e.g., family member, friend) who continuously assists the enrolled patient for at least half a day;

Exclusion Criteria:

* Inability or difficulty in understanding Italian language and/or illiteracy;
* Refusal or withdrawal of informed consent at any stage of the study

Therapists

Inclusion Criteria:

* Physiotherapists who assist enrolled patients throughout the entire intervention period

Exclusion Criteria:

* Physiotherapists who partially assist enrolled patients throughout the entire intervention period

Study 2 (ID: RM-2024-803)

Therapists

Inclusion Criteria:

* Physiotherapists who have sufficient professional experience in use of rehabilitation technology in post-stroke rehabilitation programs;

Exclusion Criteria:

* Refusal or withdrawal of informed consent at any stage of the study

Where this trial is running

Milan

• University of Milano-Bicocca — Milan, Italy (RECRUITING)

Study contacts

• Principal investigator: Patrizia Steca, PhD — University of Milano Bicocca
• Study coordinator: Marco D'Addario, PhD

Conditions: Stroke, Stroke Rehabilitation, Technology, Cognition, Quality of Life, Well-Being, Experience of Use