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

NCT07637123 | Not Yet Recruiting

• 1 other identifier: 424/SR/25
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke; Parkinson Disease

Keywords

Soft Robotics; Haptic device; Feasibility; Acceptance of Technology; Pilot Study

Outcome Measures

Primary Outcomes (5)

• 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.

  After completion of the final device-assisted experimental session, up to 4 weeks after baseline

• 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.

  After completion of the final device-assisted experimental session, up to 4 weeks after baseline

• 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).

  During each experimental session, up to 4 weeks after baseline

• 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.

  During each experimental session, up to 4 weeks after baseline

• Musculoskeletal discomfort assessed by the Extended Nordic Musculoskeletal Questionnaire

  Musculoskeletal discomfort potentially associated with device use will be assessed using the Extended Nordic Musculoskeletal Questionnaire NMQ-E). The questionnaire will be used to identify discomfort, pain, or perceived physical burden in body regions potentially affected by the wearable devices. The outcome evaluates the number of body regions with new/worsened discomfort (0-9; higher = worse)

  Before and after device-assisted experimental sessions, up to 4 weeks after baseline

Study Arms (3)

Parkinson's disease participants with soft elbow Exosuit

EXPERIMENTAL

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).

Device: Wearable upper-limb rehabilitation devices

Stroke participants with haptic armband

EXPERIMENTAL

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)

Device: Wearable upper-limb rehabilitation devices

Stroke disease participants with soft elbow Exosuit

EXPERIMENTAL

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).

Device: Wearable upper-limb rehabilitation devices

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.

Also known as: Soft elbow exosuit, Haptic armband, Wearable haptic feedback device, Upper-limb assistive wearable system

Parkinson's disease participants with soft elbow Exosuit; Stroke disease participants with soft elbow Exosuit; Stroke participants with haptic armband

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna: collaborator

Study Sites (2)

IRCCS San Raffaele Cassino

Cassino, FR, 03043, Italy

Location

IRCCS San Raffaele Roma

Roma, RM, 00163, Italy

Location

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MeSH Terms

Conditions

Stroke; Parkinson Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Francesco Infarinato, PhD

  IRCCS San Raffaele Pisana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Infarinato, PhD

CONTACT

+390652253788; francesco.infarinato@sanraffaele.it

Paola Romano, PhD

CONTACT

+390652253788; paola.romano@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Bioengineering Laboratory

Model Details: This is a non-randomized, exploratory, parallel-assignment feasibility/usability/safety/explorative study involving condition-specific participant groups. Participants are assigned to the device condition based on diagnosis, stage of recovery, residual upper-limb motor function, and device compatibility, rather than by randomization. Two groups of post-stroke participants are evaluated using either the soft elbow exosuit or the wearable haptic bracelet, depending on their functional profile. Participants with Parkinson's disease are evaluated using the soft elbow exosuit. Within the experimental sessions, device-assisted performance may be compared with baseline or non-assisted task execution, as applicable. The study is intended to assess feasibility, usability, comfort, safety, and preliminary device-related effects, rather than to establish definitive clinical efficacy.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)