StrokeEMBA-IPNCT07637123
Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients
A study testing Wearable upper-limb rehabilitation devices in people with Stroke and Parkinson Disease, run by IRCCS San Raffaele Roma at 2 sites in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Parkinson Disease
- What is being tested?
- Wearable upper-limb rehabilitation devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or older.
- Able to understand the study procedures and follow study instructions.
- Signed informed consent obtained before participation.
- Adequate cognitive function, defined as Mini-Mental State Examination score ≥24 or equivalent clinical assessment.
- Upper-limb functional limitation compatible with participation in the study.
- QuickDASH score between 20 and 70.
Show all 19Show fewer
- Arm and forearm dimensions compatible with safe and appropriate fitting of the wearable device.
- Additional inclusion criteria for stroke participants
- Clinically confirmed diagnosis of ischemic or hemorrhagic stroke, documented by computed tomography or magnetic resonance imaging.
- Upper-limb motor impairment involving the proximal upper limb, including shoulder and/or elbow functional limitation.
- Modified Ashworth Scale score <3 in the affected upper limb.
- Residual upper-limb motor function compatible with the assigned device-assisted experimental tasks.
- Fugl-Meyer Assessment Upper Extremity score ≥15.
- Additional inclusion criteria for Parkinson's disease participants
- Clinically confirmed diagnosis of idiopathic Parkinson's disease.
- Modified Hoehn and Yahr stage II or III.
- Upper-limb motor impairment such as bradykinesia, rigidity, tremor, or reduced dexterity.
- Unified Parkinson's Disease Rating Scale Part III upper-limb motor items compatible with mild-to-moderate impairment.
- Assessment performed in the "on" medication state, within two hours after levodopa intake.
Who cannot join
- Severe cognitive impairment, defined as Mini-Mental State Examination score <24, or any condition preventing comprehension of study procedures or instructions.
- Unstable medical condition that could increase risk during participation, including uncontrolled cardiovascular disease, severe respiratory failure, active systemic infection, or recent major surgery.
- Dermatological disease, open wounds, skin lesions, or skin hypersensitivity in the areas where the wearable devices would be applied.
- Contraindications to use of the study devices, including implanted pacemaker, relevant metallic implants near the application area, or known allergy to device materials.
- Severe spasticity of the affected upper limb that would prevent safe device use, defined as Modified Ashworth Scale score ≥3.
- Severe upper-limb pain that could be worsened by active or passive movement.
Show all 11Show fewer
- Participation in another interventional clinical study involving upper-limb rehabilitation or motor rehabilitation within 30 days before enrollment.
- Use of investigational drugs or investigational treatments within 30 days before study participation.
- Confirmed or suspected pregnancy.
- Any condition that, in the investigator's judgment, could interfere with study procedures, affect participant safety, or expose the participant to undue risk.
- Refusal or inability to provide signed informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
IRCCS San Raffaele Cassino
Cassino, FR, 03043
Maria F De Pandis, Prof., maria.depandis@sanraffaele.it
IRCCS San Raffaele Roma
Roma, RM, 00163
Francesco Infarinato, PhD, +390652253788, francesco.infarinato@sanraffaele.it
Sanaz Pournajaf, PT, +390652253788, sanaz.pournajaf@sanraffaele.it
About this study
Official title: Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband: Feasibility, Usability, and Clinical Impact in Post-stroke and Parkinson's Disease Patients (EMBA-IP)
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Stroke, Parkinson Disease
- Being tested
- Wearable upper-limb rehabilitation devices
- Keywords
- Soft Robotics, Haptic device, Feasibility, Acceptance of Technology, Pilot Study
- Medical subject headings
- Stroke, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable upper-limb rehabilitation devicesDevice
Also called Soft elbow exosuit, Haptic armband, Wearable haptic feedback device, Upper-limb assistive wearable system
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.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease participants with soft elbow Exosuit | Experimental | 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). Receives: Device: Wearable upper-limb rehabilitation devices |
| Stroke participants with haptic armband | Experimental | 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) Receives: Device: Wearable upper-limb rehabilitation devices |
| Stroke disease participants with soft elbow Exosuit | Experimental | 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). Receives: Device: Wearable upper-limb rehabilitation devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Before and after device-assisted experimental sessions, up to 4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a non-randomized, exploratory, parallel-assignment feasibility/usability/safety/explorative study involving condition-specific participant groups. Participants are assigned to the device condition based on diagnosis, stage of recovery, residual upper-limb motor function, and device compatibility, rather than by randomization. Two groups of post-stroke participants are evaluated using either the soft elbow exosuit or the wearable haptic bracelet, depending on their functional profile. Participants with Parkinson's disease are evaluated using the soft elbow exosuit. Within the experimental sessions, device-assisted performance may be compared with baseline or non-assisted task execution, as applicable. The study is intended to assess feasibility, usability, comfort, safety, and preliminary device-related effects, rather than to establish definitive clinical efficacy.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Principal investigator, Francesco Infarinato, IRCCS San Raffaele Roma
- Investigators
- Francesco Infarinato, PhD, Principal investigator, IRCCS San Raffaele Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637123
- Sponsor's protocol ID
- 424/SR/25
- Acronym
- EMBA-IP
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
PubMed 7636775Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
PubMed 3160243Martinez-Martin P, Gil-Nagel A, Gracia LM, Gomez JB, Martinez-Sarries J, Bermejo F. Unified Parkinson's Disease Rating Scale characteristics and structure. The Cooperative Multicentric Group. Mov Disord. 1994 Jan;9(1):76-83. doi: 10.1002/mds.870090112.
PubMed 8139608Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
PubMed 1135616Dawson AP, Steele EJ, Hodges PW, Stewart S. Development and test-retest reliability of an extended version of the Nordic Musculoskeletal Questionnaire (NMQ-E): a screening instrument for musculoskeletal pain. J Pain. 2009 May;10(5):517-26. doi: 10.1016/j.jpain.2008.11.008. Epub 2009 Apr 2.
PubMed 19345154Fundaro C, Casale R, Maestri R, Traversoni S, Colombo R, Salvini S, Ferretti C, Bartolo M, Buonocore M, Giardini A. Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q): development and implementation of an instrument to evaluate patients' perception during training. J Neuroeng Rehabil. 2023 Mar 24;20(1):35. doi: 10.1186/s12984-023-01146-3.
PubMed 36964543Proietti T, O'Neill C, Gerez L, Cole T, Mendelowitz S, Nuckols K, Hohimer C, Lin D, Paganoni S, Walsh C. Restoring arm function with a soft robotic wearable for individuals with amyotrophic lateral sclerosis. Sci Transl Med. 2023 Feb;15(681):eadd1504. doi: 10.1126/scitranslmed.add1504. Epub 2023 Feb 1.
PubMed 36724237Lotti N, Missiroli F, Galofaro E, Tricomi E, Di Domenico D, Semprini M, Casadio M, Brichetto G, De Michieli L, Tacchino A, Masia L. Soft Robotics to Enhance Upper Limb Endurance in Individuals with Multiple Sclerosis. Soft Robot. 2024 Apr;11(2):338-346. doi: 10.1089/soro.2023.0024. Epub 2023 Oct 23.
PubMed 37870773Noronha B, Ng CY, Little K, Xiloyannis M, Kuah CWK, Wee SK, Kulkarni SR, Masia L, Chua KSG, Accoto D. Soft, Lightweight Wearable Robots to Support the Upper Limb in Activities of Daily Living: A Feasibility Study on Chronic Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2022;30:1401-1411. doi: 10.1109/TNSRE.2022.3175224. Epub 2022 May 30.
PubMed 35576429Mitchell J, Shirota C, Clanchy K. Factors that influence the adoption of rehabilitation technologies: a multi-disciplinary qualitative exploration. J Neuroeng Rehabil. 2023 Jun 20;20(1):80. doi: 10.1186/s12984-023-01194-9.
PubMed 37340496Boardsworth K, Rashid U, Olsen S, Rodriguez-Ramirez E, Browne W, Alder G, Signal N. Upper limb robotic rehabilitation following stroke: a systematic review and meta-analysis investigating efficacy and the influence of device features and program parameters. J Neuroeng Rehabil. 2025 Jul 16;22(1):164. doi: 10.1186/s12984-025-01662-4.
PubMed 40671078Veerbeek JM, Langbroek-Amersfoort AC, van Wegen EE, Meskers CG, Kwakkel G. Effects of Robot-Assisted Therapy for the Upper Limb After Stroke. Neurorehabil Neural Repair. 2017 Feb;31(2):107-121. doi: 10.1177/1545968316666957. Epub 2016 Sep 24.
PubMed 27597165Connell LA, Klassen TK, Janssen J, Thetford C, Eng JJ. Delivering Intensive Rehabilitation in Stroke: Factors Influencing Implementation. Phys Ther. 2018 Apr 1;98(4):243-250. doi: 10.1093/ptj/pzy018.
PubMed 29415282French B, Thomas LH, Coupe J, McMahon NE, Connell L, Harrison J, Sutton CJ, Tishkovskaya S, Watkins CL. Repetitive task training for improving functional ability after stroke. Cochrane Database Syst Rev. 2016 Nov 14;11(11):CD006073. doi: 10.1002/14651858.CD006073.pub3.
PubMed 27841442Monje MHG, Sanchez-Ferro A, Pineda-Pardo JA, Vela-Desojo L, Alonso-Frech F, Obeso JA. Motor Onset Topography and Progression in Parkinson's Disease: the Upper Limb Is First. Mov Disord. 2021 Apr;36(4):905-915. doi: 10.1002/mds.28462. Epub 2021 Jan 20.
PubMed 33471950
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband: Feasibility, Usability, and Clinical Impact in Post-stroke and Parkinson's Disease Patients (EMBA-IP)
- ClinicalTrials.gov ID
- NCT07637123
- Acronym / sponsor ID
- EMBA-IP / 424/SR/25
- Conditions
- Stroke, Parkinson Disease
- Keywords
- Soft Robotics, Haptic device, Feasibility, Acceptance of Technology, Pilot Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jun 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a non-randomized, exploratory, parallel-assignment feasibility/usability/safety/explorative study involving condition-specific participant groups. Participants are assigned to the device condition based on diagnosis, stage of recovery, residual upper-limb motor function, and device compatibility, rather than by randomization. Two groups of post-stroke participants are evaluated using either the soft elbow exosuit or the wearable haptic bracelet, depending on their functional profile. Participants with Parkinson's disease are evaluated using the soft elbow exosuit. Within the experimental sessions, device-assisted performance may be compared with baseline or non-assisted task execution, as applicable. The study is intended to assess feasibility, usability, comfort, safety, and preliminary device-related effects, rather than to establish definitive clinical efficacy.
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease participants with soft elbow Exosuit | Experimental | Device: Wearable upper-limb rehabilitation devices15 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). |
| Stroke participants with haptic armband | Experimental | Device: Wearable upper-limb rehabilitation devices15 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) |
| Stroke disease participants with soft elbow Exosuit | Experimental | Device: Wearable upper-limb rehabilitation devices15 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18 years or older.
- Able to understand the study procedures and follow study instructions.
- Signed informed consent obtained before participation.
- Adequate cognitive function, defined as Mini-Mental State Examination score ≥24 or equivalent clinical assessment.
- Upper-limb functional limitation compatible with participation in the study.
Key exclusion criteria (11 listed)
- Severe cognitive impairment, defined as Mini-Mental State Examination score <24, or any condition preventing comprehension of study procedures or instructions.
- Unstable medical condition that could increase risk during participation, including uncontrolled cardiovascular disease, severe respiratory failure, active systemic infection, or recent major surgery.
- Dermatological disease, open wounds, skin lesions, or skin hypersensitivity in the areas where the wearable devices would be applied.
- Contraindications to use of the study devices, including implanted pacemaker, relevant metallic implants near the application area, or known allergy to device materials.
- Severe spasticity of the affected upper limb that would prevent safe device use, defined as Modified Ashworth Scale score ≥3.
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 |
|---|---|---|
| Wearable upper-limb rehabilitation devicesAlso: Soft elbow exosuit, Haptic armband, Wearable haptic feedback device, Upper-limb assistive wearable systemParticipants 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. | Device | Parkinson's disease participants with soft elbow Exosuit, Stroke disease participants with soft elbow Exosuit, Stroke participants with haptic armband |
Primary outcome
System Usability Scale score
Time frame: After completion of the final device-assisted experimental session, up to 4 weeks after baseline
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.
Quest 2.0
Time frame: After completion of the final device-assisted experimental session, up to 4 weeks after baseline
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.
Number of device-related adverse events and technical issues
Time frame: During each experimental session, up to 4 weeks after baseline
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).
Protocol completion rate
Time frame: During each experimental session, up to 4 weeks after baseline
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.
Musculoskeletal discomfort assessed by the Extended Nordic Musculoskeletal Questionnaire
Time frame: Before and after device-assisted experimental sessions, up to 4 weeks after baseline
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 7636775Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25. doi: 10.1016/0022-3999(94)00125-o.
- Background: PubMed 3160243Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
- Background: PubMed 8139608Martinez-Martin P, Gil-Nagel A, Gracia LM, Gomez JB, Martinez-Sarries J, Bermejo F. Unified Parkinson's Disease Rating Scale characteristics and structure. The Cooperative Multicentric Group. Mov Disord. 1994 Jan;9(1):76-83. doi: 10.1002/mds.870090112.
- Background: PubMed 1135616Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
- Background: PubMed 19345154Dawson AP, Steele EJ, Hodges PW, Stewart S. Development and test-retest reliability of an extended version of the Nordic Musculoskeletal Questionnaire (NMQ-E): a screening instrument for musculoskeletal pain. J Pain. 2009 May;10(5):517-26. doi: 10.1016/j.jpain.2008.11.008. Epub 2009 Apr 2.
- Background: PubMed 36964543Fundaro C, Casale R, Maestri R, Traversoni S, Colombo R, Salvini S, Ferretti C, Bartolo M, Buonocore M, Giardini A. Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q): development and implementation of an instrument to evaluate patients' perception during training. J Neuroeng Rehabil. 2023 Mar 24;20(1):35. doi: 10.1186/s12984-023-01146-3.
- Background: PubMed 36724237Proietti T, O'Neill C, Gerez L, Cole T, Mendelowitz S, Nuckols K, Hohimer C, Lin D, Paganoni S, Walsh C. Restoring arm function with a soft robotic wearable for individuals with amyotrophic lateral sclerosis. Sci Transl Med. 2023 Feb;15(681):eadd1504. doi: 10.1126/scitranslmed.add1504. Epub 2023 Feb 1.
- Background: PubMed 37870773Lotti N, Missiroli F, Galofaro E, Tricomi E, Di Domenico D, Semprini M, Casadio M, Brichetto G, De Michieli L, Tacchino A, Masia L. Soft Robotics to Enhance Upper Limb Endurance in Individuals with Multiple Sclerosis. Soft Robot. 2024 Apr;11(2):338-346. doi: 10.1089/soro.2023.0024. Epub 2023 Oct 23.
- Background: PubMed 35576429Noronha B, Ng CY, Little K, Xiloyannis M, Kuah CWK, Wee SK, Kulkarni SR, Masia L, Chua KSG, Accoto D. Soft, Lightweight Wearable Robots to Support the Upper Limb in Activities of Daily Living: A Feasibility Study on Chronic Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2022;30:1401-1411. doi: 10.1109/TNSRE.2022.3175224. Epub 2022 May 30.
- Background: PubMed 37340496Mitchell J, Shirota C, Clanchy K. Factors that influence the adoption of rehabilitation technologies: a multi-disciplinary qualitative exploration. J Neuroeng Rehabil. 2023 Jun 20;20(1):80. doi: 10.1186/s12984-023-01194-9.
- Background: PubMed 40671078Boardsworth K, Rashid U, Olsen S, Rodriguez-Ramirez E, Browne W, Alder G, Signal N. Upper limb robotic rehabilitation following stroke: a systematic review and meta-analysis investigating efficacy and the influence of device features and program parameters. J Neuroeng Rehabil. 2025 Jul 16;22(1):164. doi: 10.1186/s12984-025-01662-4.
- Background: PubMed 27597165Veerbeek JM, Langbroek-Amersfoort AC, van Wegen EE, Meskers CG, Kwakkel G. Effects of Robot-Assisted Therapy for the Upper Limb After Stroke. Neurorehabil Neural Repair. 2017 Feb;31(2):107-121. doi: 10.1177/1545968316666957. Epub 2016 Sep 24.
- Individual participant dataSharing planned: 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.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Francesco Infarinato, PhD principal investigator
IRCCS San Raffaele Pisana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable upper-limb rehabilitation devices in people with Stroke and Parkinson Disease, run by IRCCS San Raffaele Roma at 2 sites 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 19 inclusion and 11 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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Infarinato, PhD (+390652253788, francesco.infarinato@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale score (time frame: After completion of the final device-assisted experimental session, up to 4 weeks after baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07637123, which also lists 17 linked publications.
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 Jun 2026.