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.
Condition or disease | Intervention/treatment | Phase |
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Stroke | Device: Functional electrical stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Évaluation Des modalités Optimales de Pilotage et de l'Impact Sur Les capacités de préhension d'Une Stimulation électrique Fonctionnelle Des Muscles Extenseurs Des Doigts Chez le Patient hémiplégique en Phase Chronique |
Actual Study Start Date : | July 9, 2019 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2021 |
Arm | Intervention/treatment |
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No Intervention: Inactive neuroprosthesis | |
Experimental: Active neuroprosthesis |
Device: Functional electrical stimulation
Functional electrical stimulation of finger's muscles in order to open the hand
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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.
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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David GASQ, PhD, MD | 675246931 ext +33 | david.gasq@inria.fr | |
Contact: Brigitte Lafont, PhD | 466684236 ext +33 | drc@chu-nimes.fr |
France | |
CHU de Nîmes | Recruiting |
Nîmes, France | |
Contact: David GASQ | |
CHU de TOULOUSE | Not yet recruiting |
Toulouse, France, 31400 | |
Contact: David GASQ 0467418688 david.gasq@inserm.fr |
Study Chair: | Christine Azevedo, PhD | Institut National de Recherche en Informatique et en Automatique | |
Principal Investigator: | Jérôme Froger, MD | Centre Hospitalier Universitaire de Nīmes |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 24, 2019 | ||||||||
First Posted Date ICMJE | May 10, 2019 | ||||||||
Last Update Posted Date | July 17, 2020 | ||||||||
Actual Study Start Date ICMJE | July 9, 2019 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Rate of success of the main functional task [ Time Frame: Third day ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Functional Impact of a Closed-loop Controlled Grasping Neuroprosthesis in Post-stroke Patients (PREHENSTROKE) | ||||||||
Official Title ICMJE | Évaluation Des modalités Optimales de Pilotage et de l'Impact Sur Les capacités de préhension d'Une Stimulation électrique Fonctionnelle Des Muscles Extenseurs Des Doigts Chez le Patient hémiplégique en Phase Chronique | ||||||||
Brief Summary |
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. |
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Stroke | ||||||||
Intervention ICMJE | Device: Functional electrical stimulation
Functional electrical stimulation of finger's muscles in order to open the hand
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
20 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2021 | ||||||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03946488 | ||||||||
Other Study ID Numbers ICMJE | LOCAL/2018/DG-01 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Centre Hospitalier Universitaire de Nīmes | ||||||||
Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nīmes | ||||||||
Collaborators ICMJE | Institut National de Recherche en Informatique et en Automatique | ||||||||
Investigators ICMJE |
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PRS Account | Centre Hospitalier Universitaire de Nīmes | ||||||||
Verification Date | July 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |