Pilot Study: Home Use of Wearable Grasping Neuroprosthesis in Vascular Hemiparesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Evaluation of neuroprosthesis control methods
BehavioralEvaluation of head movements, foot movements and voice recognition
Neuroprosthesis implantation
DeviceLearning and training in the installation and use of the neuroprothesis
Pre-use assessments of the neuroprosthesis in a hospital setting
Behavioral* 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 setting
Behavioral* 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 home
BehavioralEvaluation 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 home
BehavioralEvaluation 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 limb
BehavioralObjective 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 setting
BehavioralPsychosocial Impact of Assistive Devices (F-PIADS) questionnaires, Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and customer satisfaction questionnaire.
Treatment groups
2 Participants
are divided into 1 treatment groupGroup A: NeuroprosthesisExperimental treatment 8 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSecondary outcomes
1
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)
Time frame
12 months2
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
Time frame
12 months3
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)
Time frame
12 months4
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)
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov