Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients (EMBA-IP)

June 5, 2026 updated by: Francesco Infarinato, IRCCS San Raffaele Roma

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parkinson's disease participants with soft elbow Exosuit

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
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.
Other Names:
  • Soft elbow exosuit
  • Haptic armband
  • Wearable haptic feedback device
  • Upper-limb assistive wearable system
Experimental: Stroke participants with haptic armband

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
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.
Other Names:
  • Soft elbow exosuit
  • Haptic armband
  • Wearable haptic feedback device
  • Upper-limb assistive wearable system
Experimental: Stroke disease participants with soft elbow Exosuit
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.
Other Names:
  • Soft elbow exosuit
  • Haptic armband
  • Wearable haptic feedback device
  • Upper-limb assistive wearable system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After completion of the final device-assisted experimental session, up to 4 weeks after baseline
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.
After completion of the final device-assisted experimental session, up to 4 weeks after baseline
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).
During each experimental session, up to 4 weeks after baseline
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.
During each experimental session, up to 4 weeks after baseline
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)
Before and after device-assisted experimental sessions, up to 4 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele Roma

Collaborators

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Investigators

  • Principal Investigator: Francesco Infarinato, PhD, IRCCS San Raffaele Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 20, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 424/SR/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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