StrokeGRASP-HOMENCT07500480
Pilot Study: Home Use of Wearable Grasping Neuroprosthesis in Vascular Hemiparesis
A study testing Neuroprosthesis implantation, Pre-use assessments of the neuroprosthesis in a hospital setting and Post-use assessments of the neuroprosthesis in a hospital setting in people with Stroke and Réhabilitation, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Réhabilitation
- What is being tested?
- Neuroprosthesis implantation, Pre-use assessments of the neuroprosthesis in a hospital setting and Post-use assessments of the neuroprosthesis in a hospital setting
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Apr 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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
Who cannot join
- 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;
Show all 18Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31400
David GASQ, MD PhD, 5 61 77 73 18 ext. +33, gasq.d@chu-toulouse.fr
- Recruiting
David GASQ
Toulouse
About this study
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
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.
- Conditions
- Stroke, Réhabilitation
- Being tested
- Evaluation of neuroprosthesis control methods, Neuroprosthesis implantation, Pre-use assessments of the neuroprosthesis in a hospital setting, Post-use assessments of the neuroprosthesis in a hospital setting, Pre-use assessments of the neuroprosthesis at home
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of neuroprosthesis control methodsBehavioural
Evaluation of head movements, foot movements and voice recognition
Neuroprosthesis implantationDevice
Learning and training in the installation and use of the neuroprothesis
Pre-use assessments of the neuroprosthesis in a hospital settingBehavioural
- 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 settingBehavioural
- 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 homeBehavioural
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 homeBehavioural
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 limbBehavioural
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 settingBehavioural
Psychosocial Impact of Assistive Devices (F-PIADS) questionnaires, Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and customer satisfaction questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Neuroprosthesis | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500480
- Sponsor's protocol ID
- RC31/24/0537
- Acronym
- GRASP-HOME
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07500480
- Acronym / sponsor ID
- GRASP-HOME / RC31/24/0537
- Conditions
- Stroke, Réhabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroprosthesis | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Patient receiving care within the standard healthcare pathway;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of neuroprosthesis control methodsEvaluation of head movements, foot movements and voice recognition | Behavioural | Neuroprosthesis |
| Neuroprosthesis implantationLearning and training in the installation and use of the neuroprothesis | Device | Neuroprosthesis |
| 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. | Behavioural | Neuroprosthesis |
| 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. | Behavioural | Neuroprosthesis |
| Pre-use assessments of the neuroprosthesis at homeEvaluation 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 | Behavioural | Neuroprosthesis |
| Post-use assessments of the neuroprosthesis at homeEvaluation 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 | Behavioural | Neuroprosthesis |
| Objective and quantified evaluation of the use of the paretic upper limbObjective and quantified evaluation of the use of the paretic upper limb with an inertial station integrated into the neuroprosthesis. | Behavioural | Neuroprosthesis |
| Post-use assessments of neuroprostheses in a hospital settingPsychosocial Impact of Assistive Devices (F-PIADS) questionnaires, Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and customer satisfaction questionnaire. | Behavioural | Neuroprosthesis |
Primary outcome
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.
5 secondary outcomes
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Time frame: 12 months
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Time frame: 12 months
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Time frame: 12 months
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Time frame: 12 months
Evaluation of the effectiveness of prolonged use of the neuroprosthesis in daily life
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroprosthesis implantation, Pre-use assessments of the neuroprosthesis in a hospital setting and Post-use assessments of the neuroprosthesis in a hospital setting in people with Stroke and Réhabilitation, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David GASQ, MD (5 61 34 00 56 ext. +33, gasq.d@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of therapeutic adherence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.