NCT07637123Not yet recruiting
Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients
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)
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 20 May 2026
- Start date
- Jun 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- IRCCS San Raffaele Roma
- Diseases
- Stroke, Parkinson disease
- NCT number
- NCT07637123
What you commit to
- Study type: Interventional
- Planned participants: 45
- From Jun 2026 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS San Raffaele Cassino Coordinator of this site? Confirm its status | Cassino | Italy | Unknown status |
| IRCCS San Raffaele Roma Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.