An interventional study of Functional electrical stimulation in Stroke, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment
Stroke is the leading cause of disability in adults. The improvement of the grasp abilities remains a challenge in the 50% of post-stroke subjects who have not recovered functional grasping due to paralysis of the finger's muscles (lack of active opening of the hand).
The use of functional electrical stimulation of the prehension muscles in order to restore grasp abilities, called grasp neuroprosthesis (GP), remained confidential in post-stroke subjects while their development was important in tetraplegic subjects. GP can provide a correct hand opening with significant functional gain, but one of the major issues corresponds to the control modalities that are not adapted to the specific impairments of post-stroke subjects.
This project proposes to assess the functional contribution of an innovative autopilot closed-loop GP targeting the extensor muscles of the fingers. The main hypothesis is that the use of GP will restore grasping abilities in subjects who have lost this ability due to post-stroke paralysis.
The main objective is to assess the impact of using an autopilot closed-loop GP on the ability to perform a standardized task of grasping, moving and releasing either a glass (palmar grasp) or a spoon (key pinch), compared to the absence of GP use.
The secondary objectives of the study are: (1) to assess the impact of the GP on unimanual grasp; (2) to assess which are the preferential modes of control; (3) to assess the psycho-social impacts of GP, and (4) to assess the subject's satisfaction and tolerance to the characteristics and use of GP.
The investigators plan to include 20 post-stroke hemiplegic subjects over a period of 9 months as part of a prospective, monocentric, multi-crossover, blinded evaluation study. Subjects will have active finger extension deficit secondary to stroke, with preservation of proximal movements. Each subject will be his own control (self-pairing).
Each subject will be evaluated three times, the protocol adding approximately 1½ hours of daily assessment to routine care already received. The first visit will collect clinical data after informed consent collection. The second visit will allow to choose the optimal mode of control of the GP among 8 modalities. The third visit will test the functional gain provided by the use of GP, by comparing the success or failure of carrying out functional tasks with inactive and active GP.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 11 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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Device: Functional electrical stimulation
Functional electrical stimulation of finger's muscles in order to open the hand
Rate of success of the main functional task
The main functional task consist of grasping, moving and releasing either a glass (palmar grasp) or a spoon (key grip): the task (palmar grasp or key grip) preferred by the patient will be chosen. The assessment will consist of 24 trials with the active or inactive neuroprosthesis (12 activated and 12 inactivated), the order of the trials with / without neuroprosthesis being randomized in blocks of at least three trials. In order to limit the fatigue potentially induced by the repetition of stimulations, a pause between each trial will be respected if necessary. The maximum time allowed for the completion of each test will be 1 minute. A success corresponds to a complete completion of the functional task in at least 2/3 of the trials (i.e. 8/12 trials) with the activated neuroprosthesis. The success / failure score will be assessed secondarily from video recordings by a blind evaluator of the activation or not of the neuroprosthesis.
Time frame: Third day
Rate of success of the secondary functional task
The secondary functional task will be the one that will not be retained as a main task (primary outcome), and consist of grasping, moving and releasing either a glass (palmar grasp) or a spoon (key grip). The assessment will consist of 24 trials with the active or inactive neuroprosthesis (12 activated and 12 inactivated), the order of the trials with / without neuroprosthesis being randomized in blocks of at least three trials. In order to limit the fatigue potentially induced by the repetition of stimulations, a pause between each trial will be respected if necessary. The maximum time allowed for the completion of each test will be 1 minute. A success corresponds to a complete completion of the functional task in at least 2/3 of the trials (i.e. 8/12 trials) with the activated neuroprosthesis. The success / failure score will be assessed secondarily from video recordings by a blind evaluator of the activation or not of the neuroprosthesis.
Time frame: Third day
Comparison of the Action Research Arm Test (ARAT) performed with the inactivated (first day) and activated (day three) neuroprosthesis
The ARAT assess different unimanual modes of prehension. The score is between 0 (the worst) and 57 (the best). The cotation will be performed secondarily from videos by a blind evaluator.
Time frame: First and third day
Psychosocial Impact of Assistive Devices (PIADS) questionnaire
The PIADS assess the psychosocial impact of the use of the neuroprosthesis in the life of the person. It is composed of 3 subscales (competence, adaptability and self-esteem), each rated between -3 (worst) and +3 (best).
Time frame: Third day
Subscale "Device" from the questionnaire Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
The subscale Device of the QUEST assess the satisfaction and tolerance with respect to the characteristics and use of the neuroprosthesis. The score is between 0 (the worst) and 5 the best).
Time frame: Third day
Plan to share: No
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes