StrokeITERNCT06489145
Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients
A study testing Technology-enhanced Rehabilitation and Multidisciplinary Traditional Rehabiltiation in people with Stroke, run by University of Milano Bicocca at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Technology-enhanced Rehabilitation and Multidisciplinary Traditional Rehabiltiation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jun 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Any informal caregiver (e.g., family member, friend) who continuously assists the enrolled patient for at least half a day;
- Physiotherapists who assist enrolled patients throughout the entire intervention period
- Physiotherapists who have sufficient professional experience in use of rehabilitation technology in post-stroke rehabilitation programs;
Who cannot join
- 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
Show all 13Show fewer
- Inability or difficulty in understanding Italian language and/or illiteracy;
- Refusal or withdrawal of informed consent at any stage of the study
- Therapists
- Physiotherapists who partially assist enrolled patients throughout the entire intervention period
- Study 2 (ID: RM-2024-803)
- Therapists
- Refusal or withdrawal of informed consent at any stage of the study
Trial locations and contacts
1 site in 1 country.
Francesco Zanatta, PhD contact
Italy1 site, 1 recruiting
- Recruiting
University of Milano-Bicocca
Milan, 20126
Marco D'Addario, 02 6448 3824, marco.daddario@unimib.it
About this study
Official title: Users' Experience and Cognitive Improvement in High-technology Rehabilitation Programs for Post-stroke Patients: a Multi-method, Multi-informant, Patient-centred Approach
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
Read the 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.
- Conditions
- Stroke
- Being tested
- Technology-enhanced Rehabilitation, Multidisciplinary Traditional Rehabiltiation
- Keywords
- Stroke Rehabilitation, Technology, Cognition, Quality of Life, Well-Being, Experience of Use
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-enhanced RehabilitationDevice
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.
Multidisciplinary Traditional RehabiltiationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Technology-enhanced Rehabilitation | Experimental | Patients will participate in technology-enhanced rehabilitation programs in addition to multidisciplinary traditional treatment. Receives: Device: Technology-enhanced Rehabilitation; Other: Multidisciplinary Traditional Rehabiltiation |
| Standard Rehabilitation | Active comparator | Patients will participate in multidisciplinary traditional treatment only Receives: Other: Multidisciplinary Traditional Rehabiltiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline to 4-week follow-up
Secondary outcomes (6)
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start24 Jun 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Principal investigator, Marco D'Addario, University of Milano Bicocca
- Investigators
- Patrizia Steca, PhD, Principal investigator, University of Milano BicoccaMarco D'Addario, PhD, Principal investigator, University of Milano BicoccaAlessandra Gorini, PhD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489145
- Sponsor's protocol ID
- 0025654/24
- Other IDs
- RM-2024-803
- Acronym
- ITER
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Users' Experience and Cognitive Improvement in High-technology Rehabilitation Programs for Post-stroke Patients: a Multi-method, Multi-informant, Patient-centred Approach
- ClinicalTrials.gov ID
- NCT06489145
- Acronym / sponsor ID
- ITER / 0025654/24
- Conditions
- Stroke
- Keywords
- Stroke Rehabilitation, Technology, Cognition, Quality of Life, Well-Being, Experience of Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- University of Milan, Istituti Clinici Scientifici Maugeri SpA
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-enhanced Rehabilitation | Experimental | Device: Technology-enhanced Rehabilitation, Other: Multidisciplinary Traditional RehabiltiationPatients will participate in technology-enhanced rehabilitation programs in addition to multidisciplinary traditional treatment. |
| Standard Rehabilitation | Active comparator | Other: Multidisciplinary Traditional RehabiltiationPatients will participate in multidisciplinary traditional treatment only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-enhanced RehabilitationBased 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. | Device | Technology-enhanced Rehabilitation |
| Multidisciplinary Traditional RehabiltiationPatients 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. | Other | Standard Rehabilitation, Technology-enhanced Rehabilitation |
Primary outcome
Pre-post Intervention Change in Motor impairment
Time frame: Baseline to 4-week follow-up
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).
Pre-post Intervention Change in Spasticity
Time frame: Baseline to 4-week follow-up
Changes will be assessed with the Asworth modified Scale (MAS). Higher scores indicate higher spasticity (range: 0-4 for each body part assessed)
Pre-post Intervention Change in upper limbs sensory and motor functions
Time frame: Baseline to 4-week follow-up
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).
Pre-post Intervention Change in Autonomy in Activities of Daily Living (ADLs)
Time frame: Baseline to 4-week follow-up
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).
Pre-post Intervention Change in Functional Disability
Time frame: Baseline to 4-week follow-up
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.
Pre-post Intervention Change in global cognition
Time frame: Baseline to 4-week follow-up
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)
Pre-post Intervention Change in Long-term Verbal Memory
Time frame: Baseline to 4-week follow-up
Changes will assessed with the Rey Auditory Verbal Memory Test (RAVLT). Higher scores indicate better long-term verbal memory functioning (range: 0-15)
Pre-post Intervention Change in Short-term Verbal Memory
Time frame: Baseline to 4-week follow-up
Changes will be assessed with the Digit Span Task (DST). Higher scores indicate better short-term verbal memory functioning (range: 3-9)
Pre-post Intervention Change in Long-term Visual-spatial Memory
Time frame: Baseline to 4-week follow-up
Changes will be assessed with the Rey-Osterrieth Complex Figure Test. Higher scores indicate better long-term visual.spatial memory functioning (range: 0-36)
Pre-post Intervention Change in Short-term Visual-spatial Memory
Time frame: Baseline to 4-week follow-up
Changes will be assessed with the Corsi Block-Tapping Test. Higher scores indicate better short-term visual-spatial memory functioning (range: 3-9)
Pre-post Intervention Change in Visual-Spatial Attention
Time frame: Baseline to 4-week follow-up
Changes will be assessed with the Multiple Features Target Cancellation (MFTC) test. Higher scores indicate better attentional and visual search abilities (range: 0-13)
Pre-post Intervention Change in Executive Functions
Time frame: Baseline to 4-week follow-up
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
Pre-post Intervention Change in Verbal Fluency
Time frame: Baseline to 4-week follow-up
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
Pre-post Intervention Change in Perceived Health Status
Time frame: Baseline to 4-week follow-up
Changes will be assessed with the EuroQoL Visual Analogue Scale (EQ-VAS). Higher scores indicate better perceived health status (range: 0-100)
Pre-post Intervention Change in Perceived Health-related Quality of Life
Time frame: Baseline to 4-week follow-up
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)
Pre-post Intervention Change in Anxiety and Depression Symptoms
Time frame: Baseline to 4-week follow-up
Changes will be assessed with the Hospital Anxiety and Depression Scale (HADS). Higher scores indicated more severe anxiety and depression symptoms (range: 0-21)
6 secondary outcomes
Change in Patient's Subjective Rehabilitation Experience
Time frame: Baseline to 4-week follow-up (Repeated measures throughout the trial)
Rehabilitation Outcomes Expectations
Time frame: Baseline
Satisfaction with Rehabilitation Treatment
Time frame: Baseline to 4-week follow-up
Technology Perceived Usability
Time frame: 4-week follow-up
Technology Acceptance
Time frame: 4-week follow-up
Technology Psychosocial Impact
Time frame: 4-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Zanatta, PhD contact
Patrizia Steca, PhD principal investigator
University of Milano Bicocca
Marco D'Addario, PhD principal investigator
University of Milano Bicocca
Alessandra Gorini, PhD principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-enhanced Rehabilitation and Multidisciplinary Traditional Rehabiltiation in people with Stroke, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco D'Addario, PhD (02 6448 3824, marco.daddario@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-post Intervention Change in Motor impairment (time frame: Baseline to 4-week follow-up). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.