An interventional study of Evaluation of neuroprosthesis control methods and Neuroprosthesis implantation in Stroke and Réhabilitation, sponsored by University Hospital, Toulouse. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Device feasibility
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 2 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
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Presence of at least one of the following two disabilities:
Exclusion Criteria:
Behavioral: Evaluation of neuroprosthesis control methods · Device: Neuroprosthesis implantation · Behavioral: Pre-use assessments of the neuroprosthesis in a hospital setting · Behavioral: Post-use assessments of the neuroprosthesis in a hospital setting · Behavioral: Pre-use assessments of the neuroprosthesis at home · Behavioral: Post-use assessments of the neuroprosthesis at home · Behavioral: Objective and quantified evaluation of the use of the paretic upper limb · Behavioral: Post-use assessments of neuroprostheses in a hospital setting
Evaluation of head movements, foot movements and voice recognition
Learning and training in the installation and use of the neuroprothesis
* 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.
* 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.
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
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 with an inertial station integrated into the neuroprosthesis.
Psychosocial Impact of Assistive Devices (F-PIADS) questionnaires, Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and customer satisfaction questionnaire.
Analysis of therapeutic adherence
Collect data on the number of times the neuroprosthesis is used per day in real-life situations in order to define an overall compliance indicator that allows for the analysis of the feasibility of using a grasping neuroprosthesis at home over a period of 1 year.
Time frame: 12 months
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Evaluation of the quality of unimanual grasping with neuroprosthesis using the Action Arm Research Test (ARAT) scale which gives a score out of 57 and which evaluates object grasping (out of 18), the way of holding something (out of 12), pinching an object (out of 18) and global movements (out of 9)
Time frame: 12 months
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Evaluation of the quality of performance of a personalized daily living task (task chosen collaboratively by the patient and therapist, assessed at the patient's home) using the Upper Limb Performance Assessment (ULPA) scale, which evaluates upper limb performance by identifying errors made during arm and hand use
Time frame: 12 months
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Performance of the use of the paretic upper limb in activities of daily living using the Motor Activity Log (MAL) questionnaire which contains 30 questions about 30 activities of daily living and the patient must rate the amount of activity performed from 0 (he did not use his arm) to 5 (he used his arm as much as before the stroke)
Time frame: 12 months
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Performance of the use of the paretic upper limb in activities of daily living using the armA questionnaire which contains 15 questions about 15 activities of daily living carried out over the last 7 days and the patient must rate the completion of the activity from 0 (he has no difficulty) to 4 (impossibility of carrying out the activity)
Time frame: 12 months
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Evaluation of paretic upper limb motor function using the Fugl-Meyer upper limb motor score, which assesses the execution of movements with the upper limb by giving a score out of 66
Time frame: 12 months
Plan to share: No
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University Hospital, Toulouse