Restoration of upper-extremity function after task-oriented, intention-driven functional electrical stimulation therapy using a wearable sleeve in adults with chronic stroke: a case series.

Background: Functional electrical stimulation (FES) has been recognized for decades as a method to retrain the motor system after stroke. Benefits of FES rehabilitation can be enhanced by combining with task-oriented rehabilitation, dubbed FES therapy (FEST). Furthermore, by synchronizing FES with the user's volitional motor intention and incorporating multiple trained tasks, FES can be better integrated into common task-oriented rehabilitation practice. Using wearable FES technology, we tested therapy incorporating these elements in two chronic stroke survivors (subjects A, B). Methods: Our group has developed the NeuroLife Sleeve, a wearable forearm sleeve that contains a high-density grid of embedded FES electrodes, that may be controlled by an operator or by the wearer's own electromyographic (EMG) signals. During eight weeks of FEST, intention-driven FES enabling multiple movements was delivered via operator control twice weekly and EMG control once weekly. Results: At the end of the therapy period, both subjects had improved their scores: Box and Blocks Test (A: +5, B: +7), the Action Arm Research Test (A: +7, B: +12), the Fugl Meyer Upper Extremity section (A: +11, B: +9), and the 9-Hole Peg Test (A: 158 sec, B: 54 sec, both previously unable). All score improvements persisted over the 10-week follow-up period despite >80% reduction to weekly FES duration. Conclusions: This case series provides additional evidence that intention-driven FEST drives long-lasting motor recovery in chronic stroke survivors. The NeuroLife Sleeve enabled this therapy through the easily donned wearable sleeve interface, control schemes for pairing FES with motor intention, and efficient transitions between tasks with programmable FES placement and parameters. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT06207240 ### Funding Statement This study did not receive any external funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Battelle Memorial Institute Institutional Review Board (IRB00000284) of Battelle Memorial Institute (FWA00004696) approved the studies (0779, 0828) under which these data were collected. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors