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

June 26, 2026 updated by: University Hospital, Toulouse

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Toulouse, France, 31400
        • Recruiting
        • University Hospital toulouse
        • Contact:
      • Toulouse, France
        • Recruiting
        • David GASQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analysis of therapeutic adherence
Time Frame: 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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