Clinical trial NCT06489145: Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients
Official title: Users' Experience and Cognitive Improvement in High-technology Rehabilitation Programs for Post-stroke Patients: a Multi-method, Multi-informant, Patient-centred Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke Rehabilitation
Technology
Cognition
Quality of Life
Well-Being
Experience of Use
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: University of Milan
name: Istituti Clinici Scientifici Maugeri SpA
First posted: 2024-07-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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, 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.

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

Primary outcomes:
measure: Pre-post Intervention Change in Motor impairment
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Spasticity
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in upper limbs sensory and motor functions
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Autonomy in Activities of Daily Living (ADLs)
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Functional Disability
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in global cognition
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Long-term Verbal Memory
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Short-term Verbal Memory
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Long-term Visual-spatial Memory
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Short-term Visual-spatial Memory
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Visual-Spatial Attention
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Executive Functions
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Verbal Fluency
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Perceived Health Status
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Perceived Health-related Quality of Life
timeFrame: Baseline to 4-week follow-up
measure: Pre-post Intervention Change in Anxiety and Depression Symptoms
timeFrame: Baseline to 4-week follow-up
Secondary outcomes:
measure: Change in Patient's Subjective Rehabilitation Experience
timeFrame: Baseline to 4-week follow-up (Repeated measures throughout the trial)
measure: Rehabilitation Outcomes Expectations
timeFrame: Baseline
measure: Satisfaction with Rehabilitation Treatment
timeFrame: Baseline to 4-week follow-up
measure: Technology Perceived Usability
timeFrame: 4-week follow-up
measure: Technology Acceptance
timeFrame: 4-week follow-up
measure: Technology Psychosocial Impact
timeFrame: 4-week follow-up
Other outcomes:
Locations:
city: Milan
country: Italy
facility: University of Milano-Bicocca
Study officials:
affiliation: University of Milano Bicocca
name: Patrizia Steca, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milano Bicocca
name: Marco D'Addario, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milan
name: Alessandra Gorini, PhD
role: PRINCIPAL_INVESTIGATOR
References: