Status:
RECRUITING
Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients
Lead Sponsor:
University of Milano Bicocca
Collaborating Sponsors:
University of Milan
Istituti Clinici Scientifici Maugeri SpA
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Through a multi-method, multi-informant, and patient-centred approach, the study aims to investigate the experience of use and the effectiveness of rehabilitation technology (robotics and virtual real...
Detailed Description
The present research will consist of two parallel studies. Study 1 (ID: 0025654/24). As a first goal the study aims to investigate pre- post-intervention changes on patients' motor, functional, cogni...
Eligibility Criteria
Inclusion
- Study 1 (ID: 0025654/24)
- Patients
- 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
- 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;
Key Trial Info
Start Date :
June 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06489145
Start Date
June 24 2024
End Date
September 30 2025
Last Update
December 9 2024
Active Locations (1)
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1
University of Milano-Bicocca
Milan, Italy, 20126