Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients
NCT Number: NCT06489145
Acronym: ITER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: DEVICE: Technology-enhanced Rehabilitation|OTHER: Multidisciplinary Traditional Rehabiltiation
Sponsor: University of Milano Bicocca
Collaborators: University of Milan|Istituti Clinici Scientifici Maugeri SpA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2025-09-30

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

Primary Outcome Measures: 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|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
Secondary Outcome Measures: 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., 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