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NCT07637123
Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients
Conditions: Stroke, Parkinson Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 45
Sponsor: IRCCS San Raffaele Roma
Location: IRCCS San Raffaele Cassino Cassino FR
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.
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 \
Source: ClinicalTrials.gov (NCT07637123). StuddyBuddy aggregates publicly available trial information.