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Tests wearable elbow and arm devices to aid movement in stroke and Parkinson's

Tests a soft elbow exosuit and a vibrating armband in stroke and Parkinson's patients.

Key facts

Who runs it
IRCCS San Raffaele Roma
Where
Cassino and Roma, ItalySee the 2 sites
Trial code
Registry title
Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients
Status
Not yet recruiting
People taking part
45 people, planned
Started
Jun 2026
Expected to end
Dec 2026
Type of study
Interventional, 3 groups
Treatments tested
  • Wearable upper-limb rehabilitation devices
Record updated
9 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with arm movement problems after a stroke or because of Parkinson's disease. They will try a soft wearable elbow device or a vibrating forearm band.

Age
18 years or older
Sex
All sexes
Disease stage
Stroke: confirmed ischemic or hemorrhagic stroke, shoulder and/or elbow movement limitation, Modified Ashworth Scale score below 3, Fugl-Meyer Upper Extremity score 15 or higher. Parkinson's disease: confirmed idiopathic Parkinson's disease, Modified Hoehn and Yahr stage II or III, tested in the "on" medication state within two hours after levodopa.
Earlier treatment
Cannot have joined another arm or motor rehabilitation study, or used investigational drugs or treatments, within 30 days before enrollment.

Main reasons for not taking part

  • Severe memory or thinking problems (Mini-Mental State Examination score below 24)
  • Unstable medical condition, such as uncontrolled heart disease or active infection
  • Skin disease, wounds or allergy where the device is worn
  • Pacemaker or metal implants near where the device is worn
  • Severe arm spasticity (Modified Ashworth Scale score 3 or higher) or severe arm pain

The registry criteria, word for word

Show all 28 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Any condition that, in the investigator's judgment, could interfere with study procedures, affect participant safety, or expose the participant to undue risk
  • 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
  • Confirmed or suspected pregnancy
  • Refusal or inability to provide signed informed consent

Where in Italy

  • IRCCS San Raffaele CassinoCassino, ItalyContact: Maria F De Pandis, Prof.No longer taking part
  • IRCCS San Raffaele RomaRoma, ItalyContact: Francesco Infarinato, PhDNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Parkinson's disease participants with soft elbow ExosuitTreatment being tested

    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).

    Treatment: Wearable upper-limb rehabilitation devices

  • Stroke participants with haptic armbandTreatment being tested

    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)

    Treatment: Wearable upper-limb rehabilitation devices

  • Stroke disease participants with soft elbow ExosuitTreatment being tested

    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).

    Treatment: Wearable upper-limb rehabilitation devices

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Tests wearable elbow and arm devices to aid movement in stroke and Parkinson'sGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 June 2026