Functional Impact of a Closed-loop Controlled Grasping Neuroprosthesis in Post-stroke Patients (PREHENSTROKE)

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · May 9, 2019

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • The patient must have given free and informed consent and signed the consent;
• • The patient must be an affiliate or a beneficiary of a health insurance plan;
• • The patient is hospitalized as part of routine care and available for at least 3 consecutive days of follow-up during hospitalization;
• • Motor deficiency of the upper limb due to a hemorrhagic or ischemic stroke;
• • Stroke more than one months old;
• • Inability to perform an active extension of the long fingers (opening of the hand) to voluntarily seize an empty glass with a palmar grip (grasping task in the ARAT scale), while the subject can hold the previously placed glass passively in the hand; and / or
• • Inability to perform an active thumb extension to voluntarily grasp the handle of a tablespoon (flat, like a key) with a pulpo-lateral thumb-index or key-grip (grasping task in the Wolf Motor Function Scale Test), while the subject can hold the spoon previously placed passively between thumb and index;
• • Ability to sit on a chair for at least 2 hours.
• Exclusion Criteria:
• • The subject participates in another interventional study;
• • The subject is in an exclusion period determined by a previous study;
• • The subject is under the protection of justice, guardianship or curatorship;
• • The subject refuses to sign or give consent;
• • It is not possible to give the subject enlightened information.
• • The patient is pregnant, parturient, or breastfeeding;
• • Patient with pacemaker;
• • Unstable epilepsy;
• • Unstable cardiovascular pathology (coronary heart disease, major hypertension, heart failure);
• • Dermatological problems counter-indicating the application of surface electrodes;
• • Musculotendinous retractions or joint stiffness of the fingers and wrist preventing passive opening of the hand sufficient to perform the functional tasks evaluated;
• • Active elbow extension limited to not reaching the ipsilateral knee, the subject sitting (limitation of the approach);
• • Upper limb pain limiting movements;
• • Major sensory disorders corresponding to a score of the Modified Erasmus Nottingham Sensory Assessment English version of 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 bell test if the difference between omissions in the left and right fields is greater than or equal to 6;
• • Common extensor digitorum muscle and / or extensor thumb muscle non-stimulable with the neuroprosthesis.