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

University of Milano Bicocca

Status: Enrolling

Conditions: Stroke

Treatments: Device: Technology-enhanced Rehabilitation; Other: Multidisciplinary Traditional Rehabiltiation

Study type: Interventional

Funder types: Other

Identifiers

NCT06489145

0025654/24

RM-2024-803 (Other Identifier)

Details and patient eligibility

About

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 reality - VR) in post-stroke patients and their caregivers and therapists

Full 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, cognitive, psychological and quality of life outcomes. Intervention effects will be estimated among patients participating in technology-enhanced rehabilitation programs and compared to those undergoing traditional treatment only.

As a second goal, the study aims to evaluate patients' subjective rehabilitation experience, treatment expectations and compliance, and (in case of technology use) devices usability, acceptability and psychosocial impact.

As a third goal, the study aims to extend the evaluation on rehabilitation experience to patients' caregivers, specifically investigating their treatment expectations and, at the end of the intervention, treatment satisfaction.

As a fourth goal, the study aims to evaluate the rehabilitation experience and technology experience of use in patients' therapists, specifically investigating their treatment expectations and, at the end of the intervention, patients' compliance and participation levels in the treatment.

Study 2 (ID: RM-2024-803). Therapists will be also involved in a parallel qualitative investigation through focus-groups to further explore the barriers and facilitators related to the implementation of technological devices into post-stroke rehabilitation programs.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Technology-enhanced Rehabilitation

Experimental group

Description:

Patients will participate in technology-enhanced rehabilitation programs in addition to multidisciplinary traditional treatment.

Treatment:

Other: Multidisciplinary Traditional Rehabiltiation

Device: Technology-enhanced Rehabilitation

Standard Rehabilitation

Active Comparator group

Description:

Patients will participate in multidisciplinary traditional treatment only

Treatment:

Other: Multidisciplinary Traditional Rehabiltiation