Pilot Study: Home Use of Wearable Grasping Neuroprosthesis in Vascular Hemiparesis (GRASP-HOME)

Pilot Study Evaluating the Usability and Functional Impact of Prolonged Home Use of a Wearable Grasping Neuroprosthesis in Subjects With Vascular Hemiparesis - GRASP-HOME

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Réhabilitation
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David GASQ, MD; Phone Number: +33 5 61 34 00 56; Email: gasq.d@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • David GASQ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion CriteriA/

• Adult patient who participated in and completed the GRASP-AGAIN study and achieved functional improvement through the use of NAP.
• Motor deficit of an upper limb resulting from a single ischemic or hemorrhagic stroke, hemispheric or brainstem, confirmed by brain imaging (CT scan or MRI);
• Brain lesion occurring more than one month prior;

• Presence of at least one of the following two disabilities:

  • Inability to actively extend the long fingers (open the hand) to actively grasp an empty glass (upper and lower diameters of 7 and 6 cm respectively, height of 12 to 15 cm, weight of 125 g, identical to the material used for the Action Research Arm Test scale) with a palmar grip, without the aid of the other hand, while the subject is able to hold the glass passively in the hand;
  • Inability to actively extend the thumb to grasp the handle of a soup spoon (flat, like a key) without the aid of the other hand, using a thumb-index finger pulp-lateral grip (grasping task in the Wolf Motor Function Test), while the subject can passively hold the handle of a spoon or a key previously placed between the thumb and index finger;
• Patient receiving care within the standard healthcare pathway;
• Ability to sit in a chair and remain focused for at least 1.5 hours;
• Free, informed, and written consent signed by the participant and the investigator (no later than the day of enrollment and before any examination required for the research);
• Individual affiliated with or covered by a social security scheme

Exclusion Criteria:

• The person is in labor or breastfeeding;
• The person is pregnant, the diagnosis being guided by questioning (date of last menstrual period, desire for pregnancy, contraception) and possibly confirmed by a blood test for beta hCG;
• Musculotendinous contractures or joint stiffness of the fingers and wrist preventing passive opening of the fingers;
• Limited approach ability preventing the hand from being positioned in front of the abdomen (without contact) at the level of the midline sagittal plane, while the subject is seated;
• Paretic pain in the upper limb limiting the performance of the standardized grasping task;
• Major sensory disturbances corresponding to a Somatosensation subscore of the modified Erasmus Nottingham Sensory Assessment French version (EmNSA-F, see Appendix A) upper limb <10/44;
• Severe aphasia with a Boston Diagnostic Severity Aphasia Examination Severity Scale score ≤ 3, see Appendix B, indicating that there may be a marked decrease in verbal fluency or ease and rapidity of comprehension, without significant limitation of expression or communication;
• Known gestural apraxia, within the limits of the subject's motor abilities (ideomotor apraxia, ideational apraxia, dressing apraxia, or reflexive apraxia);
• Unilateral spatial neglect demonstrated with the bell test (see Appendix B'), if the difference between omissions in the left and right visual fields is greater than or equal to 6;
• The extensor digitorum communis and/or extensor pollicis longus muscles cannot be stimulated with the neuroprosthesis, meaning that sufficient extension of the long fingers and/or thumb for grasping tasks is not achieved with electrical stimulation well tolerated by the patient;
• The person has a pacemaker;
• Presence of uncontrolled epilepsy;
• Presence of unstable cardiovascular disease (coronary artery disease, severe hypertension, heart failure);
• Presence of a dermatological condition contraindicating the application of surface electrodes;
• The person is participating in another research study with an ongoing exclusion period;
• The person is under legal guardianship or conservatorship;
• The person refuses to sign the consent form;
• It proves impossible to provide the person with informed consent and ensure their compliance due to impaired physical and/or psychological health.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Neuroprosthesis

Behavioral: Evaluation of neuroprosthesis control methods; Evaluation of head movements, foot movements and voice recognition; Device: Neuroprosthesis implantation; Learning and training in the installation and use of the neuroprothesis; Behavioral: 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.; Behavioral: 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.; Behavioral: 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; Behavioral: 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; Behavioral: 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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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)	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)	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	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: RC31/24/0537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No