Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients

Launched by UNIVERSITY OF MILANO BICOCCA · Jul 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how effective new rehabilitation technologies, like robotics and virtual reality (VR), can help patients who have had a stroke. The study aims to understand both the benefits of these technologies and the experiences of patients, their caregivers, and therapists during the rehabilitation process. Researchers are looking for individuals who have had a stroke within the past year and are between the ages of 18 and 74. Participants should have some movement ability in their arms and be able to understand the study’s goals.

If you or a loved one qualify and decide to participate, you can expect to use advanced rehabilitation tools designed to support recovery. Caregivers who help the patients daily and therapists with experience in rehabilitation technology are also invited to join the study. All participants will share their experiences to help improve future rehabilitation programs for stroke patients. It’s important to note that individuals with severe cognitive issues or certain medical conditions may not be eligible for this trial.

Gender

ALL

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