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NCT07637123

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

Sponsor: IRCCS San Raffaele Roma

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06

Completion Date

2026-12

Last Updated

2026-06-09

Healthy Volunteers

Conditions

Stroke Parkinson Disease

Interventions

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.

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.

Locations (2)

IRCCS San Raffaele Cassino

Cassino, FR, Italy

IRCCS San Raffaele Roma

Roma, RM, Italy