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Pilot Study: Home Use of Wearable Grasping Neuroprosthesis in Vascular Hemiparesis
Sponsor: University Hospital, Toulouse
Summary
Stroke is the leading cause of acquired motor disability in adults. Six months post-stroke, 50% of patients have not regained active finger extension, and 80% retain a grasping deficit, most commonly an inability to actively open the hand. This motor impairment significantly impacts daily activities, social interactions, professional life, and overall quality of life. Despite numerous treatments available in rehabilitation centers during the subacute phase, no functional assistive devices are currently usable at home. Since 2018, our team, in collaboration with the CAMIN-INRIA team, has developed a Grasp Neuroprosthesis (GNP). This device uses functional electrical stimulation to restore grasping function in hemiplegic subjects, enhancing autonomy in daily bimanual tasks. The GNP has been evaluated in hospital settings through two studies, defining preferred control modalities and demonstrating significant functional impact. Additionally, another study tested a wearable version of the GNP used autonomously at home for two months. This study showed the feasibility and functional benefits of home GNP use, provided the device is customizable to the patient's characteristics and environment. Initial results indicate improved quality of life and increased autonomy with GNP use. The wearable GNP consist of a forearm orthosis made of soft fabric, integrating an electrode array and a stimulator (CE medical marking for home use), connected via WiFi to a microprocessor positioned in a pouch. The microprocessor incorporates information from inertial measurement units and a microphone, allowing the user to control the electrical stimulator on demand. The stimulation targets the extensor muscles of the long fingers and the thumb, enabling the user to open the hand on demand. We propose extending the home use of the GNP to two patients for one year. Each subject will be followed for one year, with evaluations in a hospital setting at the beginning and end of the period, monthly follow-ups at home throughout the year, and on-demand video consultations.
Official title: Pilot Study Evaluating the Usability and Functional Impact of Prolonged Home Use of a Wearable Grasping Neuroprosthesis in Subjects With Vascular Hemiparesis - GRASP-HOME
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2
Start Date
2026-03-23
Completion Date
2027-04-30
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Evaluation of neuroprosthesis control methods
Evaluation of head movements, foot movements and voice recognition
Neuroprosthesis implantation
Learning and training in the installation and use of the neuroprothesis
Pre-use assessments of the neuroprosthesis in a hospital setting
* Unimanual grasping skills assessed with the neuroprosthesis activated and inactivated (blind video scoring): standardized grasping score and Action Research Arm Test (ARAT). * Use of the paretic upper limb in daily life: Motor Activity Log (MAL) score and Arm Activity Measure (ArmA) active portion score. * Voluntary upper limb motor function: upper limb subscore of the Fugl-Meyer Motor Scale.
Post-use assessments of the neuroprosthesis in a hospital setting
* Unimanual grasping skills assessed with the neuroprosthesis activated and inactivated (blind video scoring): standardized grasping score and Action Research Arm Test (ARAT). * Use of the paretic upper limb in daily life: Motor Activity Log (MAL) score and Arm Activity Measure (ArmA) active portion score. * Voluntary upper limb motor function: upper limb subscore of the Fugl-Meyer Motor Scale.
Pre-use assessments of the neuroprosthesis at home
Evaluation of the quality of performance of a personalized daily living task, objectively assessed using the Upper Limb Performance Assessment (ULPA; blinded video rating) score and subjectively assessed using the Goal Attainment Scale (GAS) score
Post-use assessments of the neuroprosthesis at home
Evaluation of the quality of performance of a personalized daily living task, objectively assessed using the Upper Limb Performance Assessment (ULPA; blinded video rating) score and subjectively assessed using the Goal Attainment Scale (GAS) score
Objective and quantified evaluation of the use of the paretic upper limb
Objective and quantified evaluation of the use of the paretic upper limb with an inertial station integrated into the neuroprosthesis.
Post-use assessments of neuroprostheses in a hospital setting
Psychosocial Impact of Assistive Devices (F-PIADS) questionnaires, Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and customer satisfaction questionnaire.