Stroke, RehabilitationGRASP-AGAINNCT05625113
Wearable Grasping Neuroprosthesis Used at Home in Subjects With Post-stroke Hemiparesis
A study testing neuroprosthesis in people with Stroke, Rehabilitation, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The study is focused on the evaluation of the feasibility, usability, acceptability, tolerance, functional impact and organizational impact of the use of a wearable prehension neuroprosthesis (innovative medical device) at home, with triggering methods specifically adapted to a population of hemiparetic post-stroke… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Rehabilitation
- What is being tested?
- neuroprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2023to 23 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Paresis of an upper limb from a single ischemic or hemorrhagic, hemispheric or brainstem stroke, as evidenced by brain imaging (CT or MRI);
- Stroke more than one month old;
- Impossibility to actively expand the fingers 2 to 5 (opening of the hand) to intentionally grab an empty glass (identical to the material used for the Action Research scale Arm Test), with a palmar grip (cylindrical grip), while the subject can hold the glass passively placed in the hand and/or the thumb to voluntarily grab the handle of a tablespoon (flat, like a wrench) with a key-grip (identical to that of the Wolf Motor Function Test), while the subject can hold the spoon previously placed passively between thumb and index;
- Ability to sit on a chair at least during 1h30. Participants must have participated in and completed the PREHENS-STROKE protocol, having successfully achieved a functional gain through the use of the neuroprosthesis.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any investigation required by the research);
- Affiliate or beneficiary of the French health insurance system;
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- The person is of age (at least 18 years old);
- Women and men are included;
- The patient is available for a follow-up of 5 days as part of his hospitalization performed as part of routine care.
Who cannot join
- The person is parturient, or is breastfeeding;
- The person is pregnant, the diagnosis being guided by the interrogation (date of the last menstruation, desire of pregnancy, contraception) and possibly confirmed by a blood test (beta hCG);
- Musculotendinous retractions or joint stiffness of the fingers and wrist preventing passive opening of the hand sufficient to perform at least one of the functional tasks evaluated; •Limitation of the approach which does not make it possible to carry out the task of gripping in front of the trunk, the subject sitting; Upper limb pain limiting achievement of the primary standardized grasping task;
- Major sensory disorders corresponding to a sub-score Somesthesia of the modified Erasmus Nottingham Sensory Assessment French version (EmNSA-F) for the upper limb <10/44; Severe aphasia with aphasia severity scale of the Boston Diagnostic Severity Aphasia Examination 3, indicating that there may be a clear decrease in verbal fluency or ease and speed of understanding, with no significant limitation expression or communication;
- Unilateral spatial negligence highlighted with the bells test if the difference between the omissions in the left and right fields is greater than or equal to 6; Extensor digitorum communis muscle and/or pollicis extensor longus muscle not stimulable with the neuroprosthesis, i.e. a sufficient extension of fingers and/or thumb for grasping tasks is not obtained with an electrical stimulation well supported by the patient.
- The person is carrying a pacemaker;
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- Presence of unstable epilepsy; Presence of unstable cardio-vascular disease (coronary heart disease, major hypertension, heart failure); Presence of a dermatological problem against indicating the application of surface electrodes.
- Concerning associated treatments: The person should not receive an injection of botulinum toxin in the upper limb during the period of inclusion in the protocol, or in the 30 days prior to inclusion.
- Concerning legislative aspects: The person is participating in another research protocol including an exclusion period still in progress; The person is under the protection of justice or guardianship; The person refuses to sign the consent; It is not possible to give the person informed information and to make sure of the subject's compliance due to impaired physical and/or psychological health.
- The participant must not have a planned rehabilitation stay in hospital during the inclusion phase (8 weeks).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Evaluating the Feasibility, Usability and Functional Impact of a Wearable Grasping Neuroprosthesis Used at Home in Subjects With Post-stroke Hemiparesis
The study is focused on the evaluation of the feasibility, usability, acceptability, tolerance, functional impact and organizational impact of the use of a wearable prehension neuroprosthesis (innovative medical device) at home, with triggering methods specifically adapted to a population of hemiparetic post-stroke subjects. The main objective is to describe the overall therapeutic compliance represented by the number of uses of the neuroprosthesis in real-life situations.
Read the detailed description
Nearly 80% of stroke survivors are affected by a grip deficit. Studies had shown the potential interest of functional supplementation by functional electrical stimulation of the fingers' extensor muscles to restore gripping capacities. The limit of some studies is that they assess gripping abilities in a hospital environment, which is a non-ecological situation very different from the daily life situations. The interest of this type of device will only be established if it restores gripping capacities in the daily life of the subjects in order to allow them to improve their level of autonomy and their quality of life. The objective of the study will be to test the feasibility and usability of a wearable version of a gripping neuroprosthesis in daily life situations. The subjects will use the neuroprosthesis for 2 months at home with evaluations at the beginning and at the end of the protocol associated with a weekly follow-up in order to evaluate the modalities of use and the functional benefits linked to its use.
- Conditions
- Stroke, Rehabilitation
- Being tested
- neuroprosthesis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuroprosthesisDevice
Use at least one time every day the gripping neuroprosthesis in daily life activities.
| Study group | Role | What they receive |
|---|---|---|
| neuroprosthesis | Experimental | This is a prospective, monocentric, real-life, feasibility case series, succeeding to the PREHENS-STROKE study, aimed at assessing the feasibility, acceptability, tolerance, efficacy and organizational impact of the use of a gripping neuroprosthesis at home (innovative medical device) in a population of vascular hemiparetic patients. The study consists of an initial phase of inclusion and evaluation (T1 and T2), an intermediate phase (T3 to T9) of learning and use of the gripping neuroprosthesis at home by the patient and a final phase (T10 and T11) of evaluation of the impact of the use of the neuroprosthesis. Each patient is their own control (self-matching). Receives: Device: neuroprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with the use of the neuroprosthesis
Overall therapeutic compliance described by the proportion of days when at least one task was performed compared to the number of days when the neuroprosthesis was available and functional (concept of delivered dose), independently of the functional task performed. This indicator is recorded automatically by the neuroprosthesis software (objective outcome). In the event of non-compliance, the data collected in the logbook, in the observation book and by the neuroprosthesis will make it possible to explain the reasons. This criterion will be evaluated at the end of the protocol.
Measured: through study completion, mean of daily collection during 2 month
Secondary outcomes (2)
Duration of daily use of the neuroprosthesis
Feasibility of the use of neuroprosthesis in daily life by analysis of therapeutic observance. It is described during the last visit of the protocol with the data collected during the protocol in the observation notebook by the therapist, the logbook by the patient or automatically recorded by the neuroprosthesis software. The dose delivered and the dose received will be described individually and a median value and its span (minimum - maximum) will be given to describe the population.
Measured: through study completion, mean of daily collection during 2 month
Efficacy related to the use of neuroprosthesis
Comparison of the quality of one-handed grips between the beginning and the end of the protocol with neuroprosthesis activated/inactivated (analysis of blinded videos) with standardized one-handed gripping tasks and the Action Arm Research Test (ARAT) scale.
Measured: through study completion, mean of daily collection during 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start17 Jan 2023
- Primary completion23 Jul 2023
- Study completion23 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, RehabilitationStudies 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
- Model description
- One arm with participants who are not blinded. All participants benefit from the intervention (neuroprosthesis). Some outcomes (functional unimanual and bimanual task, ARAT) are blinded regarding whether or not the neuroprosthesis is activated (assessment from videos).
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David GASQ, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625113
- Sponsor's protocol ID
- RC31/20/0432
- Acronym
- GRASP-AGAIN
- Status last verified
- May 2026
- First submitted
- 21 Oct 2022
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Feasibility, Usability and Functional Impact of a Wearable Grasping Neuroprosthesis Used at Home in Subjects With Post-stroke Hemiparesis
- ClinicalTrials.gov ID
- NCT05625113
- Acronym / sponsor ID
- GRASP-AGAIN / RC31/20/0432
- Conditions
- Stroke, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 23 Jul 2023 (actual)
- Study completion
- 23 Jul 2023 (actual)
- First posted
- 22 Nov 2022 (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.
The study is focused on the evaluation of the feasibility, usability, acceptability, tolerance, functional impact and organizational impact of the use of a wearable prehension neuroprosthesis (innovative medical device) at home, with triggering methods specifically adapted to a population of hemiparetic post-stroke subjects. The main objective is to describe the overall therapeutic compliance represented by the number of uses of the neuroprosthesis in real-life situations.
Detailed description
Nearly 80% of stroke survivors are affected by a grip deficit. Studies had shown the potential interest of functional supplementation by functional electrical stimulation of the fingers' extensor muscles to restore gripping capacities. The limit of some studies is that they assess gripping abilities in a hospital environment, which is a non-ecological situation very different from the daily life situations. The interest of this type of device will only be established if it restores gripping capacities in the daily life of the subjects in order to allow them to improve their level of autonomy and their quality of life. The objective of the study will be to test the feasibility and usability of a wearable version of a gripping neuroprosthesis in daily life situations. The subjects will use the neuroprosthesis for 2 months at home with evaluations at the beginning and at the end of the protocol associated with a weekly follow-up in order to evaluate the modalities of use and the functional benefits linked to its use.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One arm with participants who are not blinded. All participants benefit from the intervention (neuroprosthesis). Some outcomes (functional unimanual and bimanual task, ARAT) are blinded regarding whether or not the neuroprosthesis is activated (assessment from videos).
| Arm | Type | Receives |
|---|---|---|
| neuroprosthesis | Experimental | Device: neuroprosthesisThis is a prospective, monocentric, real-life, feasibility case series, succeeding to the PREHENS-STROKE study, aimed at assessing the feasibility, acceptability, tolerance, efficacy and organizational impact of the use of a gripping neuroprosthesis at home (innovative medical device) in a population of vascular hemiparetic patients. The study consists of an initial phase of inclusion and evaluation (T1 and T2), an intermediate phase (T3 to T9) of learning and use of the gripping neuroprosthesis at home by the patient and a final phase (T10 and T11) of evaluation of the impact of the use of the neuroprosthesis. Each patient is their own control (self-matching). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Paresis of an upper limb from a single ischemic or hemorrhagic, hemispheric or brainstem stroke, as evidenced by brain imaging (CT or MRI);
- Stroke more than one month old;
- Impossibility to actively expand the fingers 2 to 5 (opening of the hand) to intentionally grab an empty glass (identical to the material used for the Action Research scale Arm Test), with a palmar grip (cylindrical grip), while the subject can hold the glass passively placed in the hand and/or the thumb to voluntarily grab the handle of a tablespoon (flat, like a wrench) with a key-grip (identical to that of the Wolf Motor Function Test), while the subject can hold the spoon previously placed passively between thumb and index;
- Ability to sit on a chair at least during 1h30. Participants must have participated in and completed the PREHENS-STROKE protocol, having successfully achieved a functional gain through the use of the neuroprosthesis.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any investigation required by the research);
Key exclusion criteria (10 listed)
- The person is parturient, or is breastfeeding;
- The person is pregnant, the diagnosis being guided by the interrogation (date of the last menstruation, desire of pregnancy, contraception) and possibly confirmed by a blood test (beta hCG);
- Musculotendinous retractions or joint stiffness of the fingers and wrist preventing passive opening of the hand sufficient to perform at least one of the functional tasks evaluated; •Limitation of the approach which does not make it possible to carry out the task of gripping in front of the trunk, the subject sitting; Upper limb pain limiting achievement of the primary standardized grasping task;
- Major sensory disorders corresponding to a sub-score Somesthesia of the modified Erasmus Nottingham Sensory Assessment French version (EmNSA-F) for the upper limb <10/44; Severe aphasia with aphasia severity scale of the Boston Diagnostic Severity Aphasia Examination 3, indicating that there may be a clear decrease in verbal fluency or ease and speed of understanding, with no significant limitation expression or communication;
- Unilateral spatial negligence highlighted with the bells test if the difference between the omissions in the left and right fields is greater than or equal to 6; Extensor digitorum communis muscle and/or pollicis extensor longus muscle not stimulable with the neuroprosthesis, i.e. a sufficient extension of fingers and/or thumb for grasping tasks is not obtained with an electrical stimulation well supported by the patient.
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 |
|---|---|---|
| neuroprosthesisUse at least one time every day the gripping neuroprosthesis in daily life activities. | Device | neuroprosthesis |
Primary outcome
Compliance with the use of the neuroprosthesis
Time frame: through study completion, mean of daily collection during 2 month
Overall therapeutic compliance described by the proportion of days when at least one task was performed compared to the number of days when the neuroprosthesis was available and functional (concept of delivered dose), independently of the functional task performed. This indicator is recorded automatically by the neuroprosthesis software (objective outcome). In the event of non-compliance, the data collected in the logbook, in the observation book and by the neuroprosthesis will make it possible to explain the reasons. This criterion will be evaluated at the end of the protocol.
2 secondary outcomes
Duration of daily use of the neuroprosthesis
Time frame: through study completion, mean of daily collection during 2 month
Efficacy related to the use of neuroprosthesis
Time frame: through study completion, mean of daily collection during 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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. This study is not recruiting at the moment.
David GASQ, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuroprosthesis in people with Stroke, Rehabilitation, run by University Hospital, Toulouse at 1 site 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 1 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with the use of the neuroprosthesis (time frame: through study completion, mean of daily collection during 2 month). 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 1 Jun 2026.