Pilot Study: Home Use of Wearable Grasping Neuroprosthesis in Vascular Hemiparesis

Summary

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.

Conditions

• Stroke
• Réhabilitation

Interventions

BEHAVIORAL

Evaluation of neuroprosthesis control methods

Evaluation of head movements, foot movements and voice recognition

DEVICE

Neuroprosthesis implantation

Learning and training in the installation and use of the neuroprothesis

BEHAVIORAL

Pre-use assessments of the neuroprosthesis in a hospital setting

* 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.

BEHAVIORAL

Post-use assessments of the neuroprosthesis in a hospital setting

* 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.

BEHAVIORAL

Pre-use assessments of the neuroprosthesis at home

Evaluation 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

BEHAVIORAL

Post-use assessments of the neuroprosthesis at home

Evaluation 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

BEHAVIORAL

Objective and quantified evaluation of the use of the paretic upper limb

Objective and quantified evaluation of the use of the paretic upper limb with an inertial station integrated into the neuroprosthesis.

BEHAVIORAL

Post-use assessments of neuroprostheses in a hospital setting

Psychosocial Impact of Assistive Devices (F-PIADS) questionnaires, Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) and customer satisfaction questionnaire.

Sponsors & Collaborators

• University Hospital, Toulouse

  lead OTHER

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-23

Primary Completion

2027-04-30

Completion

2027-04-30