The aim of the PREHENS-STROKE study is to propose a functional replacement device to restore grip capacities in patients with hemiparesis after stroke, unable to actively open the hand to seize objects. The main objective is to evaluate the impact of the use of a self-controlled prehension neuroprosthesis on the ability to perform a standardized grasping task, consisting of grasping, relocating and releasing a glass (palmar grasp) or a spoon (key-pinch), compared to a condition without the use of the prehension neuroprosthesis.
Concerning the study population: 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.
Concerning legislative aspects: 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; 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.
Concerning the study population: 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, 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.
Concerning the associated pathologies: The person is carrying a pacemaker; 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.
Single group
Prehension neuroprosthesis
DeviceThe experimental condition corresponds to patients in the condition where the prehension neuroprosthesis is active, which means that the extensor muscles of the fingers and thumb will be stimulated by the prehension neuroprosthesis to ensure the opening of the hand. The prehension neuroprosthesis designates a functional electrical stimulation device controlled by the patient which will itself trigger the stimulation of the extensor muscles of the fingers (closed-loop control), according to stimuli which it controls voluntarily. The goal is to restore an opening of the fingers to capture objects. The control condition corresponds to the patients in the condition where the prehension neuroprosthesis is inactive.
Success rate of a main standardized gripping task performed
The primary endpoint is a comparison of the success rate of a main standardized gripping task performed with the activated and inactivated prehension neuroprosthesis. This task consists of grasping, moving and releasing either an object with a palmar grasp (glass) or a key grip between thumb and index (to catch the handle of a spoon or a key). During the visit T3, the patient chooses the main functional task from the two standardized tasks (the other becomes the secondary task). The evaluation consists of 24 trials with active or inactive prehension neuroprosthesis (12 activated and 12 inactivated). The criterion selected as a success corresponds to the success of at least 70 percent of the tests, i.e. 8 out of 12 trials in each condition. This success / failure score is made from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis, from data collected during the visit T4 (5th and last day).
Comparison of success rate
Comparison of success rate when performing the secondary standardized gripping task performed with the activated and inactivated prehension neuroprosthesis. Evaluation is identical to the main standardized gripping task. This success / failure score is made from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis, from data collected during the visit T4 (5th and last day).
Qualitative analysis
Qualitative analysis of the reasons for choosing the prehension neuroprosthesis closed-loop control modalities, among the 6 modalities initially proposed, carried out during the visit T1 (second day).
Analysis of the quality
Analysis of the quality (rated between 0 and 5) of the capture, transport and release phases, during each test of the main and secondary standardized gripping tasks (data collected during visit T4). The assessment is made in a delayed manner from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis. An analysis according to the n-of-1 trials methodology is performed to determine the link between activation / inactivation of the prehension neuroprosthesis and the quality and duration of the movement studied.
Analysis of the the duration
Analysis of the the duration (in seconds) of the capture, transport and release phases, during each test of the main and secondary standardized gripping tasks (data collected during visit T4). The assessment is made in a delayed manner from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis. An analysis according to the n-of-1 trials methodology is performed to determine the link between activation / inactivation of the prehension neuroprosthesis and the quality and duration of the movement studied.
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