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ClinicalTrials.gov ID

NCT07637123

Lead Sponsor

IRCCS San Raffaele RomaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

45Estimated

Last Update Posted

Jun 9, 2026Actual

Start Date

Jun 2026Estimated

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

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)

Brief 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. 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.

• Stroke
• Parkinson Disease

• Wearable upper-limb rehabilitation devices

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Other

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

IRCCS San Raffaele RomaOTHER

Collaborators

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'AnnaOTHER

francesco.infarinato@sanraffaele.it+390652253788