An interventional study of Wearable upper-limb rehabilitation devices in Stroke and Parkinson Disease, sponsored by IRCCS San Raffaele Roma. Not yet recruiting at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by IRCCS San Raffaele Roma · Not applicable, Interventional, and Other
Among 12 studies in Stroke by IRCCS San Raffaele Roma — 4 open to participants now, 5 under way, none of them phase 3. Stroke · IRCCS San Raffaele Roma.
Among the 12 studies in Stroke by IRCCS San Raffaele Roma, this one is the only one that started in 2026, is one of 9 with no phase, and was the 11th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 45 is close to the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →4 of the 12 studies in Stroke by IRCCS San Raffaele Roma are open now, in 6 countries. Each count lists the studies.
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2026.
Median enrollment 50 across the 9 interventional studies, 105 across the 3 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
IRCCS San Raffaele Roma is the lead sponsor of 71 studies on the registry; 25 are open to participants now.
3 of the studies in Stroke by IRCCS San Raffaele Roma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04559724IRCCS San Raffaele RomaGait Training Through a Novel Over-ground Wearable Robotic System in People With Pyramidal Hemisyndromes | 2026-12 |
| NCT07637123IRCCS San Raffaele RomaEvaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients | 2026-12 |
| NCT06906588IRCCS San Raffaele RomaBilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke | 2026-12-31 |
Among the 12 studies in Stroke by IRCCS San Raffaele Roma, from their registry updates:
This pilot feasibility study will evaluate a wearable soft elbow exosuit and a haptic forearm bracelet for upper-limb neurorehabilitation in people with stroke and Parkinson's disease. The soft elbow exosuit is designed to assist elbow flexion and extension during functional motor tasks while preserving comfort and natural movement, with the possibility of deploying vibrotactile stimuli. The haptic bracelet provides tactile and vibrotactile feedback to support sensorimotor engagement, movement guidance, and proprioceptive awareness.
The study will assess the feasibility, usability, comfort, acceptability, safety, and preliminary clinical impact of these devices in a real neurorehabilitation setting. Participants with stroke will be tested using either the soft elbow exosuit or the haptic bracelet, depending on their stage of recovery and residual upper-limb motor function. Participants with Parkinson's disease will be tested with the soft elbow exosuit combined with integrated haptic feedback, with specific interest in motor performance and tremor modulation.
Participants will undergo baseline clinical and functional assessment, followed by supervised experimental sessions involving upper-limb functional tasks such as reaching, grasping, releasing, pick-and-place exercises, elbow flexion-extension, forearm pronation-supination, and fine or gross motor activities. Sessions may be performed with and without device assistance. Non-invasive sensors, including inertial measurement units and electromyography, will be used to collect movement and muscle activity data. User experience will be assessed using standardized questionnaires addressing usability, satisfaction, perceived benefit, comfort, and musculoskeletal discomfort.
The study is intended to generate preliminary evidence on the safe and acceptable use of wearable soft robotic and haptic technologies in neurological rehabilitation and to inform the design of future larger clinical trials.
This clinical investigation is designed to evaluate the use of wearable assistive and haptic technologies for upper-limb rehabilitation in neurological populations. The study focuses on two non-invasive devices: a soft wearable elbow exosuit intended to assist elbow flexion-extension, and a wearable haptic forearm bracelet intended to provide tactile and vibrotactile feedback during upper-limb motor tasks. The technologies are intended to support motor practice, sensorimotor engagement, and task-oriented rehabilitation while maintaining comfort and allowing natural movement.
The rationale for the study is based on the persistent need for scalable, acceptable, and clinically usable technologies that can enhance upper-limb rehabilitation after stroke and in Parkinson's disease. Upper-limb motor impairment is common in both conditions and may limit independence, functional performance, and quality of life. Although intensive, repetitive, and task-oriented rehabilitation is associated with better outcomes, its delivery in routine clinical practice may be constrained by time, staffing, and physical workload. Wearable soft robotic and haptic systems may help address these limitations by providing movement assistance, sensory feedback, and objective measurement during supervised rehabilitation activities.
Participants will complete an initial clinical and functional assessment followed by supervised experimental sessions in which the devices will be used during standardized upper-limb tasks. These activities may include reaching, grasping, releasing, pick-and-place movements, elbow flexion-extension, forearm pronation-supination, and other functional exercises selected according to the participant's clinical condition and motor ability. Tasks will be performed in seated position under the supervision of qualified clinical staff, with rest periods provided as needed. Device-assisted and non-assisted conditions may be compared to explore feasibility, user experience, and preliminary effects on movement performance.
In participants with stroke, the soft elbow exosuit will be evaluated primarily as an assistive device for individuals requiring support during elbow movement, whereas the haptic bracelet will be evaluated in participants with sufficient residual voluntary motor control to interact with sensory feedback during active rehabilitation tasks. In participants with Parkinson's disease, the combined use of elbow assistance and haptic feedback will be explored, with particular attention to upper-limb motor performance and tremor-related movement fluctuations during functional tasks.
The study will collect both objective and subjective data. Objective assessments will include non-invasive biomechanical and physiological measures, such as kinematic data from inertial sensors and muscle activity from surface electromyography, recorded during standardized motor tasks. These data will be used to explore changes in movement quality, joint motion, smoothness, compensatory strategies, muscle activation patterns, and tremor-related features where applicable. Subjective assessments will address usability, comfort, perceived benefit, satisfaction, technology acceptance, and possible musculoskeletal discomfort associated with device use.
The primary purpose of the study is to determine whether these wearable technologies can be feasibly, safely, and acceptably integrated into supervised neurorehabilitation sessions. The study will also generate preliminary information on user experience, device performance, and short-term motor effects. The findings are expected to inform refinements of the devices, optimize future rehabilitation protocols, and support the design of larger controlled clinical studies evaluating wearable soft robotic and haptic technologies for upper-limb neurorehabilitation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional inclusion criteria for stroke participants
Additional inclusion criteria for Parkinson's disease participants
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15 participants with Parkinson's disease will perform supervised upper-limb motor tasks using the soft elbow exosuit. The intervention will be explored for feasibility, usability, comfort, safety, movement performance, and tremor-related motor features during functional upper-limb tasks. Associated Intervention: Device (Soft elbow exosuit).
Device: Wearable upper-limb rehabilitation devices
15 participants with stroke will perform supervised upper-limb rehabilitation tasks using the wearable device intervention according to their motor profile and protocol-defined procedures. Sessions may include functional reaching, grasping, releasing, pick-and-place tasks, elbow flexion-extension, and/or forearm pronation-supination, with objective movement and muscle activity recordings. Associated Intervention: Device (haptic armband)
Device: Wearable upper-limb rehabilitation devices
15 participants with stroke will perform supervised upper-limb rehabilitation tasks using the wearable Soft Elbow Exosuit intervention according to their motor profile and protocol-defined procedures. Sessions may include functional reaching, grasping, releasing, pick-and-place tasks, elbow flexion-extension, and/or forearm pronation-supination, with objective movement and muscle activity recordings. Associated Intervention: Device (soft elbow Exosuit).
Device: Wearable upper-limb rehabilitation devices
Participants will use non-invasive wearable devices designed to support upper-limb rehabilitation during supervised motor tasks. The intervention may include a soft elbow exosuit that assists elbow flexion and extension or a haptic forearm bracelet that provides tactile or vibrotactile feedback during task-oriented upper-limb exercises. The devices will be used during functional activities such as reaching, grasping, releasing, pick-and-place movements, elbow flexion-extension, and forearm pronation-supination. Sessions will be supervised by qualified clinical staff, and device use will be adapted to the participant's diagnosis, motor abilities, and protocol-defined experimental condition. The intervention is intended to evaluate feasibility, usability, comfort, safety, user experience, and preliminary effects on upper-limb motor performance.
Also known as: Soft elbow exosuit, Haptic armband, Wearable haptic feedback device, Upper-limb assistive wearable system
System Usability Scale score
The usability of the wearable upper-limb rehabilitation devices will be assessed using the System Usability Scale. The scale provides a total score ranging from 0 to 100, with higher scores indicating better perceived usability.
Time frame: After completion of the final device-assisted experimental session, up to 4 weeks after baseline
Quest 2.0
Participant satisfaction with the wearable device intervention will be assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0). The questionnaire evaluates satisfaction (score from 1 to 5) with device characteristics such as comfort, ease of use, effectiveness, and overall acceptability. Higher scores indicate greater satisfaction.
Time frame: After completion of the final device-assisted experimental session, up to 4 weeks after baseline
Number of device-related adverse events and technical issues
Safety and device performance will be assessed by recording the number, type, and severity of device-related adverse events, discomfort episodes, technical malfunctions, usability problems, or session interruptions occurring during use of the wearable upper-limb rehabilitation devices. The evaluation of this specific outcome will be based on counting issues (0 to N; higher = worse).
Time frame: During each experimental session, up to 4 weeks after baseline
Protocol completion rate
Feasibility will be assessed as the proportion of enrolled participants who complete all protocol-defined experimental sessions and assessments. The scoring will be calculated as the proportion (%) of the completed protocol-defined sessions (0-100%). A higher completion rate will indicate greater feasibility of the study procedures and device use in the clinical rehabilitation setting.
Time frame: During each experimental session, up to 4 weeks after baseline
Musculoskeletal discomfort assessed by the Extended Nordic Musculoskeletal Questionnaire
Musculoskeletal discomfort potentially associated with device use will be assessed using the Extended Nordic Musculoskeletal Questionnaire NMQ-E). The questionnaire will be used to identify discomfort, pain, or perceived physical burden in body regions potentially affected by the wearable devices. The outcome evaluates the number of body regions with new/worsened discomfort (0-9; higher = worse)
Time frame: Before and after device-assisted experimental sessions, up to 4 weeks after baseline
Plan to share: No — Individual participant data will not be made available to other researchers. The study involves a small sample of participants with neurological conditions and includes sensitive clinical, biomechanical, and physiological data. Data will be stored in pseudonymized form and used for the purposes approved by the Ethics Committee and described in the informed consent documentation. Aggregate study results may be disseminated through scientific publications and/or conference presentations.
Start is estimated for Jun 2026; primary completion for Dec 2026, 6 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 6 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele Roma