Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele Roma
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Wearable upper-limb rehabilitation devices
DeviceParticipants 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Parkinson's disease participants with soft elbow ExosuitExperimental treatment 1 intervention
Group B: Stroke participants with haptic armbandExperimental treatment 1 intervention
Group C: Stroke disease participants with soft elbow ExosuitExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
System Usability Scale score
The usability of the wearable upper-limb rehabilitation devices will be assessed using the System Usability Scale. The scale provides a total score ranging from 0 to 100, with higher scores indicating better perceived usability.
Time frame
After completion of the final device-assisted experimental session, up to 4 weeks after baseline2
Quest 2.0
Participant satisfaction with the wearable device intervention will be assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0). The questionnaire evaluates satisfaction (score from 1 to 5) with device characteristics such as comfort, ease of use, effectiveness, and overall acceptability. Higher scores indicate greater satisfaction.
Time frame
After completion of the final device-assisted experimental session, up to 4 weeks after baseline3
Number of device-related adverse events and technical issues
Safety and device performance will be assessed by recording the number, type, and severity of device-related adverse events, discomfort episodes, technical malfunctions, usability problems, or session interruptions occurring during use of the wearable upper-limb rehabilitation devices. The evaluation of this specific outcome will be based on counting issues (0 to N; higher = worse).
Time frame
During each experimental session, up to 4 weeks after baseline4
Protocol completion rate
Feasibility will be assessed as the proportion of enrolled participants who complete all protocol-defined experimental sessions and assessments. The scoring will be calculated as the proportion (%) of the completed protocol-defined sessions (0-100%). A higher completion rate will indicate greater feasibility of the study procedures and device use in the clinical rehabilitation setting.
Time frame
During each experimental session, up to 4 weeks after baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS San Raffaele Roma
Lead sponsor
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Collaborator
Source ClinicalTrials.gov
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