The aim of the PREHENS-STROKE study is to propose a functional replacement device to restore grip capacities in patients with hemiparesis after stroke, unable to actively open the hand to seize objects. The main objective is to evaluate the impact of the use of a self-controlled prehension neuroprosthesis on the ability to perform a standardized grasping task, consisting of grasping, relocating and releasing a glass (palmar grasp) or a spoon (key-pinch), compared to a condition without the use of the prehension neuroprosthesis.
Stroke is the leading cause of motor impairment acquired after 40 years. Of the affected patients, 50% do not recover active finger extension and there is no satisfactory solution for functional recovery of the grip in these patients. The use of wearable exoskeletons to improve the grip is limited by their size and cost. An alternative is the use of functional electrical stimulation of the grasping muscles, named prehension neuroprosthesis, well developed in the spinal cord injured patient. In the adult hemiplegic patient, only about ten studies concerned the functional impact of a prehension neuroprosthesis, which have shown potential to perform a correct hand opening linked with a significant functional gain. Nevertheless, one of the major problems concerns the definition of the optimal modalities to control the prehension neuroprosthesis, modalities which until now have proved unsuitable for post-stroke patients: an open-loop control with manual triggering of the neuroprosthesis (press-button type) is not suitable with daily living use; control with the contralateral upper-limb is also not suitable for everyday use where bimanual tasks are required; and finally, the use of the residual voluntary electromyographic activity of the targeted muscle limits the opening of the fingers and the reliability of the control by promoting the occurrence of spastic cocontractions of the flexors of the fingers. In this context, the present project proposes to evaluate the functional contribution of a closed-loop controlled prehension neuroprosthesis that will restore an extension of the fingers and the thumb in order to improve the grip function. Each patient is evaluated 5 times during visits lasting between 1h30 and 2 hours. Patients are already admitted to standard care for a period of at least 5 consecutive days in the Rehabilitation Center. The visit (Day 1) will include the patient and collect the Action Arm Research Test (ARAT) and Upper Limb Performance Assessment (ULPA) scores achieved with the inactive prehension neuroprosthesis. The visit T1 (day 2) will select the preferred control mode of the neuroprosthesis. The visit T2 (day 3) and T3 (day 4) will allow learning and training in the use of the neuroprosthesis. The visit T4 (day 5) will evaluate the functional impact of the neuroprosthesis: the patients will perform the standardized primary and secondary gripping tasks with the activated or inactivated neuroprosthesis, then the ARAT and ULPA with activated neuroprosthesis, and finally the Psychosocial Impact of Assistive Devices Scale and the Device subscale of the Quebec User Assessment of Satisfaction with Assistive Technology questionnaire will be completed. The end of the visit T4 corresponds to the end of the patient's inclusion in the research protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
30
The experimental condition corresponds to patients in the condition where the prehension neuroprosthesis is active, which means that the extensor muscles of the fingers and thumb will be stimulated by the prehension neuroprosthesis to ensure the opening of the hand. The prehension neuroprosthesis designates a functional electrical stimulation device controlled by the patient which will itself trigger the stimulation of the extensor muscles of the fingers (closed-loop control), according to stimuli which it controls voluntarily. The goal is to restore an opening of the fingers to capture objects. The control condition corresponds to the patients in the condition where the prehension neuroprosthesis is inactive.
University Hospital
Toulouse, France
RECRUITINGSuccess rate of a main standardized gripping task performed
The primary endpoint is a comparison of the success rate of a main standardized gripping task performed with the activated and inactivated prehension neuroprosthesis. This task consists of grasping, moving and releasing either an object with a palmar grasp (glass) or a key grip between thumb and index (to catch the handle of a spoon or a key). During the visit T3, the patient chooses the main functional task from the two standardized tasks (the other becomes the secondary task). The evaluation consists of 24 trials with active or inactive prehension neuroprosthesis (12 activated and 12 inactivated). The criterion selected as a success corresponds to the success of at least 70 percent of the tests, i.e. 8 out of 12 trials in each condition. This success / failure score is made from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis, from data collected during the visit T4 (5th and last day).
Time frame: 5 days
Comparison of success rate
Comparison of success rate when performing the secondary standardized gripping task performed with the activated and inactivated prehension neuroprosthesis. Evaluation is identical to the main standardized gripping task. This success / failure score is made from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis, from data collected during the visit T4 (5th and last day).
Time frame: 5 days
Qualitative analysis
Qualitative analysis of the reasons for choosing the prehension neuroprosthesis closed-loop control modalities, among the 6 modalities initially proposed, carried out during the visit T1 (second day).
Time frame: 2 days
Analysis of the quality
Analysis of the quality (rated between 0 and 5) of the capture, transport and release phases, during each test of the main and secondary standardized gripping tasks (data collected during visit T4). The assessment is made in a delayed manner from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis. An analysis according to the n-of-1 trials methodology is performed to determine the link between activation / inactivation of the prehension neuroprosthesis and the quality and duration of the movement studied.
Time frame: 5 days
Analysis of the the duration
Analysis of the the duration (in seconds) of the capture, transport and release phases, during each test of the main and secondary standardized gripping tasks (data collected during visit T4). The assessment is made in a delayed manner from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis. An analysis according to the n-of-1 trials methodology is performed to determine the link between activation / inactivation of the prehension neuroprosthesis and the quality and duration of the movement studied.
Time frame: 5 days
Comparison of the Action Research Arm Test score
Comparison of the Action Research Arm Test score (ARAT, score between 0 and 57, evaluation of different unimanual grip modes) performed with the inactivated (visit T0) and activated (visit T4) prehension neuroprosthesis. The assessment is made in a delayed manner from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis.
Time frame: 5 days
Comparison of the Upper Limb Performance Assessment score
Comparison of the Upper Limb Performance Assessment score (ULPA, score 0 to 100, evaluation of bimanual hand grips) performed with the inactivated (visit T0) and activated (visit T4) prehension neuroprosthesis. The assessment is made in a delayed manner from video recordings, by an evaluator blinded to the activation or not of the prehension neuroprosthesis.
Time frame: 5 days
Evaluation of the effect of the prehension neuroprosthesis
Evaluation of the effect of the prehension neuroprosthesis in the person's life with the 3 subscales (competence, adaptability and self-esteem) of the score Psychosocial Impact of Assistive Devices Scale (F-PIADS, score between - 3 and +3 for each subscale). Data collected during the visit T4.
Time frame: 5 days
Evaluation of the patient satisfaction and tolerance
Evaluation of the patient satisfaction and tolerance to the use of the prehension neuroprosthesis with the Device subscale of the Quebec User Assessment of Satisfaction with Assistive Technology (QUEST, scoring between 0 and 5). Data collected during the visit T4.
Time frame: 5 days
Evaluate the modification of the brain activations
Evaluate the modification of the brain activations (localization of maximum desynchronization) recorded by electroencephalography, during the performance of a standardized functional task (similar to the main a standardized functional task) with and without NAP. Data collected during the visit T4.
Time frame: 5 days
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