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

Sponsor
IRCCS San Raffaele Roma
Study ID
NCT07637123
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Wearable upper-limb rehabilitation devices — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jun 9, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Parkinson's disease participants with soft elbow Exosuit
    15 participants with Parkinson's disease will perform supervised upper-limb motor tasks using the soft elbow exosuit. The intervention will be explored for feasibility, usability, comfort, safety, movement performance, and tremor-related motor features during functional upper-limb tasks. Associated Intervention: Device (Soft elbow exosuit).
  • Experimental: Stroke participants with haptic armband
    15 participants with stroke will perform supervised upper-limb rehabilitation tasks using the wearable device intervention according to their motor profile and protocol-defined procedures. Sessions may include functional reaching, grasping, releasing, pick-and-place tasks, elbow flexion-extension, and/or forearm pronation-supination, with objective movement and muscle activity recordings. Associated Intervention: Device (haptic armband)
  • Experimental: Stroke disease participants with soft elbow Exosuit
    15 participants with stroke will perform supervised upper-limb rehabilitation tasks using the wearable Soft Elbow Exosuit intervention according to their motor profile and protocol-defined procedures. Sessions may include functional reaching, grasping, releasing, pick-and-place tasks, elbow flexion-extension, and/or forearm pronation-supination, with objective movement and muscle activity recordings. Associated Intervention: Device (soft elbow Exosuit).

Primary Outcome Measure

System Usability Scale score [ Time Frame: After completion of the final device-assisted experimental session, up to 4 weeks after baseline ]

Central Contacts

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