Wearable Grasping Neuroprosthesis Used At Home in Subjects with Post-stroke Hemiparesis

NCT05625113 | Completed

• 1 other identifier: RC31/20/0432
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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 subjects. The main objective is to describe the overall therapeutic compliance represented by the number of uses of the neuroprosthesis in real-life situations.

Conditions

Stroke, Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, mean of daily collection during 2 month

Secondary Outcomes (2)

• Duration of daily use of the neuroprosthesis

  through study completion, mean of daily collection during 2 month

• Efficacy related to the use of neuroprosthesis

  through study completion, mean of daily collection during 2 month

Study Arms (1)

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).

Device: neuroprosthesis

Interventions

neuroprosthesis DEVICE

Use at least one time every day the gripping neuroprosthesis in daily life activities.

neuroprosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David GASQ, MD PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 22, 2022
• Study Start: January 17, 2023
• Primary Completion: July 23, 2023
• Study Completion: July 23, 2023
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

FR (1)