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| ID | Type | Description | Link |
|---|---|---|---|
| RM-2024-803 | Other Identifier | University of Milano-Bicocca |
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| Name | Class |
|---|---|
| University of Milan | OTHER |
| Istituti Clinici Scientifici Maugeri SpA | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology-enhanced Rehabilitation | Experimental | Patients will participate in technology-enhanced rehabilitation programs in addition to multidisciplinary traditional treatment. |
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| Standard Rehabilitation | Active Comparator | Patients will participate in multidisciplinary traditional treatment only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology-enhanced Rehabilitation | Device | Based on their individualized rehabilitation project, patients will undergo robot-assisted therapy (RAT) and/or virtual reality (VR)-based treatment. RAT will consist of the use exoskeleton devices intended for the treatment of upper limbs (Armeo-Spring™) or for the lower limbs (Lokomat™) impairments. VR-based rehabilitation will be conducted non-immersive VR devices: the ProKin 252™ (TechnoBody SRL, Italy), the D-Wall™ (TechnoBody SRL, Italy), and the Walker View™ (TechnoBody SRL, Italy). Technology-enhanced treatment duration (number of sessions, minutes of use) will strictly depend on patients' rehabilitation needs and individualized rehabilitation program. Overall, part of the duration of the whole treatment will be dedicated to the use of the technological device, resulting in the same amount of rehabilitation for all participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-post Intervention Change in Motor impairment | Changes will be assessed with the Motricity Index (MI). Higher scores indicate lower motor impairment in terms of muscle strength and upper and lower limbs motricity (range: 0-33). | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Spasticity | Changes will be assessed with the Asworth modified Scale (MAS). Higher scores indicate higher spasticity (range: 0-4 for each body part assessed) | Baseline to 4-week follow-up |
| Pre-post Intervention Change in upper limbs sensory and motor functions | Changes will be assessed with the Fugl-Meyer Upper Extremity Scale (FMUE). Higher scores indicate lower sensory-motor disability (Upper limb motor function, range: 0-66; lower limb motor function, range: 0-34; sensory function, range:0-24; balance, range: 0-14; joint range of motion, range: 0-44; joint pain, range:0-44). | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Autonomy in Activities of Daily Living (ADLs) | Changes will be assessed with the Barthel Index Modified (BIM). Higher scores (range: 0-100) indicate higher autonomy levels in ADLs (chair/bed transfer, ambulation, stair climbing, toilet transfer, bowel control, bladder control, bathing, dressing, personal hygiene, feeding). | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Functional Disability | Changes will be assessed with the Functional Independence Measure (FIM), which includes two sub-scales evaluating motor (range: 13-91) and cognitive (range: 5-35) domains in relation to disability. Higher scores indicate lower levels of motor and cognitive disability. | Baseline to 4-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient's Subjective Rehabilitation Experience | Changes will be monitored through Ecological Momentary Assessment (EMA) method. Patients will be asked to fill out a daily diary after each therapy session and indicate their rehabilitation experience in terms of engagement, motivation, enjoyment and satisfaction. Selected items from the Intrinsic Motivation Inventory (IMI) will be administered. Higher scores indicate better subjective rehabilitation experience. |
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Study 1 (ID: 0025654/24)
Patients
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Caregivers
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Therapists
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Study 2 (ID: RM-2024-803)
Therapists
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco D'Addario, PhD | Contact | 02 6448 3824 | marco.daddario@unimib.it | |
| Francesco Zanatta, PhD | Contact | francesco.zanatta@unimib.it |
| Name | Affiliation | Role |
|---|---|---|
| Patrizia Steca, PhD | University of Milano Bicocca | Principal Investigator |
| Marco D'Addario, PhD | University of Milano Bicocca | Principal Investigator |
| Alessandra Gorini, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Milano-Bicocca | Recruiting | Milan | 20126 | Italy |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Multidisciplinary Traditional Rehabiltiation | Other | Patients will receive traditional treatment consisting of two daily one-hour session (4 weeks, 20 sessions) and including rehabilitation activities like range of motion exercises (passive, active assisted and active), progressive resistive exercises, balance and strength training, and aerobic conditioning. The intervention procedures will follow the routine multidisciplinary clinical practice of the Institute where the study will be carried out. Procedures will be adapted according to patient's medical diagnosis, disability severity, and to the consequent rehabilitation objectives in favor of an individualized rehabilitation project and program. If necessary, patients might therefore undergo parallel rehabilitation activities (ie, occupational therapy, speech therapy, cognitive stimulation) that will be kept under control throughout data collection and analyses. |
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| Pre-post Intervention Change in global cognition | Changes will be assessed with the Mini Mental State Examination (MMSE), which includes sub-scores on temporal and spatial orientation, attention, executive functions, memory, language, and visual-spatial abilities. Higher scores indicate better global cognitive functioning (range: 0-30) | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Long-term Verbal Memory | Changes will assessed with the Rey Auditory Verbal Memory Test (RAVLT). Higher scores indicate better long-term verbal memory functioning (range: 0-15) | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Short-term Verbal Memory | Changes will be assessed with the Digit Span Task (DST). Higher scores indicate better short-term verbal memory functioning (range: 3-9) | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Long-term Visual-spatial Memory | Changes will be assessed with the Rey-Osterrieth Complex Figure Test. Higher scores indicate better long-term visual.spatial memory functioning (range: 0-36) | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Short-term Visual-spatial Memory | Changes will be assessed with the Corsi Block-Tapping Test. Higher scores indicate better short-term visual-spatial memory functioning (range: 3-9) | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Visual-Spatial Attention | Changes will be assessed with the Multiple Features Target Cancellation (MFTC) test. Higher scores indicate better attentional and visual search abilities (range: 0-13) | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Executive Functions | Changes will be assessed with the Trail Making Test (TMT). Higher time scores (i.e., seconds) indicate worse divided attention, cognitive flexibility, shifting and visual-motor coordination functions | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Verbal Fluency | Changes will be assessed with Phonemic and Semantic Verbal Fluency tests. Higher scores (i.e., number of words) indicated better linguistic and verbal fluency functions | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Perceived Health Status | Changes will be assessed with the EuroQoL Visual Analogue Scale (EQ-VAS). Higher scores indicate better perceived health status (range: 0-100) | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Perceived Health-related Quality of Life | Changes will be assessed with the Short-Form Health Survey-12 (SF-12). Higher scores in bot sub-scales (Mental Health and Physical Health) indicate better perceived health-related quality of life (range: 0-100) | Baseline to 4-week follow-up |
| Pre-post Intervention Change in Anxiety and Depression Symptoms | Changes will be assessed with the Hospital Anxiety and Depression Scale (HADS). Higher scores indicated more severe anxiety and depression symptoms (range: 0-21) | Baseline to 4-week follow-up |
| Baseline to 4-week follow-up (Repeated measures throughout the trial) |
| Rehabilitation Outcomes Expectations | Expectations will be assessed with the Expectancy sub-scale of the Credibility/Expectancy Questionnaire (CEQ). The assessment will be carried out on patients, their caregivers and therapists. Higher scores indicate more positive expectations on rehabilitation outcomes (range: 0-100) | Baseline |
| Satisfaction with Rehabilitation Treatment | Satisfaction levels in patients' caregivers will be assessed with Involvement practices scale. Higher scores indicate more positive caregiver's perception of information giving from rehabilitation staff, involvement in decision-making, and training to collaborate (range: 0-30) | Baseline to 4-week follow-up |
| Technology Perceived Usability | Perceived usability of the technological devices implemented will be assessed with the System Usability Scale (SUS). Higher scores indicate better technological device usability (range: 0-100) | 4-week follow-up |
| Technology Acceptance | Acceptance will be assessed with the Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q). Higher scores indicate higher technology acceptance in terms of engagement levels, usability, distress and perceived hindrance (range: 31-124) | 4-week follow-up |
| Technology Psychosocial Impact | Psychosocial impact will be assessed with the Psychosocial Impact of Assistive Device Scale (PIADS). Higher scores indicate better impact on patient's perceived adaptability (range: -18/+18), ability (range: -36/+36), and self-esteem (range: -24/+24). | 4-week follow-up |
| University of Milan |
| Principal Investigator |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |