[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06655636":3,"trial-entities:NCT06655636":116,"trial-summary:NCT06655636":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":52,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":70,"locations":73,"central_contacts":95,"overall_officials":102,"references":103,"see_also_links":115},"NCT06655636","STU00218538","Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors","Assisting Stroke Survivors With Engineering Technology (ASSET): Design Project D3: Exoskeletal Networks for Forearm Supination","RECRUITING","2025-12","2025-01","2025-01-09","2024-12-04","Shirley Ryan AbilityLab","OTHER",false,"The purpose of this study is to evaluate the safety, feasibility, and efficacy of an exoskeletal network of passive, multi-joint springs for forearm supination. Also known as the forearm ExoNET, the device is a passive, robotic device that will properly assist forearm supination in the post-stroke adult population.","The ExoNET, a passive robotic solution that provides a soft, biomimetic, and elastic alternative to robotics that embodies intelligence within the mechanical design. Several groups have been exploring performance enhancement using springs with custom-tuned parameters via optimization. Here, it is possible to have a simple reconfigurable system that can not only assist performance, but can also make training easier, faster, and more complete. This contribution has the potential to be clinically significant for rehabilitating neurologically impaired individuals because this proposal will investigate how motor learning can be facilitated through novel assistive technology.\n\nThe primary objective of this study is to evaluate the safety, feasibility, and efficacy of using the forearm ExoNET. Specifically, investigators would like to see if the forearm ExoNET tuned to assistance will lead to a reduction in forearm muscle activity and an increase in active supination range of motion. To accomplish this, we plan to have participants perform upper extremity activities of daily living requiring active forearm supination wearing the ExoNET. To achieve these goals, we will use a wearable surface electromyography (EMG) and inertial measurement unit (IMU) using Delsys wearable sensors on the forearm muscles.\n\nInvestigators hypothesize that individuals with post-stroke arm movement deficits will experience gains in Action Research Arm Test (ARAT) measures that are significantly above their baseline levels while using the forearm ExoNET tuned to supination assistive support. Secondarily, investigators hypothesize that a forearm ExoNET tuned to supination assistive support will lead to a significant reduction in arm muscle activity and no significant difference in range of motion across a series of upper-extremity tasks in adults without a history of stroke. Lastly, it is hypothesized that usage of a forearm ExoNET tuned to supination anti-assistance can be safe, feasible and tolerated by patients in a given treatment session.",[19,20],"Stroke","Cerebral Vascular Accident",[22,23,19],"Upper Extremity","Rehabilitation","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},30,"ESTIMATED",[32,39,43],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Device tuned to Assistance","The device spring components will be tuned to produce an assistive supination torque on the forearm.",[37,38],"Group 1 - Assistance, Sham, Anti-Assistance","Group 2 - Sham, Assistance, Anti-Assistance",{"type":33,"name":40,"description":41,"armGroupLabels":42},"Device tuned to Sham (Slack Springs)","The device spring components will be tuned to slack springs to serve as a placebo. The user will think they are receiving forces but in reality the device will not be providing any forces.",[37,38],{"type":33,"name":44,"description":45,"armGroupLabels":46},"Device tuned to Anti-Assistance","The device spring components will be tuned to produce a resistive supination torque on the forearm.",[37,38],[48],{"measure":49,"description":50,"timeFrame":51},"Action Research Arm Test (ARAT)","Observational measure used to assess change in upper extremity performance in individuals with a damaged nervous system","Tested at week 1 (baseline evaluations), week 2 (post evaluation), week 3 (post evaluation)",[53,56],{"measure":54,"description":55,"timeFrame":51},"Upper extremity portion of the Fugl-Meyer (FMUE)","Observational measure used to measure change in upper extremity impairment in individuals with a damaged nervous system",{"measure":57,"description":58,"timeFrame":51},"Box and Blocks","Measures change in unilateral gross motor dexterity","ALL","40 Years","70 Years",true,{"inclusion":64,"exclusion":65,"raw_text":69},[],[66,67,68],"Implanted with electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic induction pumps, and implanted stimulators","Irritated skin or open wounds","Silver allergy","Inclusion Criteria:\n\n1. Between the ages of 40-70 (to reduce confounding effects of aging on muscle, movement accuracy and proprioception)\n2. Have sustained a single, unilateral stroke at least 8 months prior to enrollment\n3. Severe to moderate upper extremity impairment (ARAT score 0-30)\n4. Ability to move their elbow and wrist when supported against gravity\n5. Cortical stroke with hemiparesis, tactile sensation\n6. Available medical records about lesion locations indicating the stroke was caused by a middle cerebral artery ischemic infarct\n\nExclusion Criteria:\n\n1. Bilateral paresis\n2. Diffuse\u002Fmultiple lesion sites or multiple stroke events\n3. Hemispatial neglect or visual field cut that prevent visual feedback\n4. Shoulder pain and\u002For articular rigidity on the upper limb joint\n5. Severe sensory deficits indicated by the Two-Point Discrimination Test\n6. Botox injection to the affected upper extremity within the previous 4 months\n7. Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to consent, perform the experiment, or follow commands\n8. Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy\n9. Other neurological issues\n10. Meet any of the contraindications to Delsys Trigno Sensors:\n\n    * Implanted with electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic induction pumps, and implanted stimulators\n    * Irritated skin or open wounds\n    * Silver allergy",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":13,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":92},"Chicago","Illinois","60610","United States",[80,85,88,91],{"name":81,"role":82,"phone":83,"email":84},"Courtney Celian, OTR\u002FL","CONTACT","312-238-1560","ccelian@sralab.org",{"name":86,"role":87},"James Patton, PhD","PRINCIPAL_INVESTIGATOR",{"name":89,"role":90},"Valentino I Wilson, MEng","SUB_INVESTIGATOR",{"name":81,"role":90},{"lat":93,"lon":94},41.85003,-87.65005,[96,100],{"name":97,"role":82,"phone":98,"email":99},"Valentino I Wilson","630-398-2355","viwilso2@uic.edu",{"name":101,"role":82,"phone":83,"email":84},"Courtney Celian, MSOT",[],[104,108,111,113],{"pmid":105,"type":106,"citation":107},"27646624","BACKGROUND","Lannin NA, Cusick A, Hills C, Kinnear B, Vogel K, Matthews K, Bowring G. Upper limb motor training using a Saebo orthosis is feasible for increasing task-specific practice in hospital after stroke. Aust Occup Ther J. 2016 Dec;63(6):364-372. doi: 10.1111\u002F1440-1630.12330. Epub 2016 Sep 19.",{"pmid":109,"type":106,"citation":110},"21261965","Gijbels D, Lamers I, Kerkhofs L, Alders G, Knippenberg E, Feys P. The Armeo Spring as training tool to improve upper limb functionality in multiple sclerosis: a pilot study. J Neuroeng Rehabil. 2011 Jan 24;8:5. doi: 10.1186\u002F1743-0003-8-5.",{"type":106,"citation":112},"J. S. Sulzer, M. A. Peshkin and J. L. Patton, "MARIONET: An exotendon-driven rotary series elastic actuator for exerting joint torque," 9th International Conference on Rehabilitation Robotics, 2005. ICORR 2005., Chicago, IL, USA, 2005, pp. 103-108, doi: 10.1109\u002FICORR.2005.1501062.",{"type":106,"citation":114},"Ryali, P., Carella, T., McDermed, D., Perizes, V., Huang, F., & Patton, J. (2020). A Theoretical Framework for a Network of Elastic Elements Generating Arbitrary Torque Fields. In 2020 8th IEEE RAS\u002FEMBS International Conference for Biomedical Robotics and Biomechatronics (BioRob) (pp. 286-291). IEEE.",[],{"nct_id":4,"conditions":117,"biomarkers":118},[19],[],{"nct_id":4,"found":62,"summary":120,"prompt_version":130},{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This interventional study plans to enroll 30 participants to test three different settings of the ExoNET device: assistance, sham (placebo), and anti-assistance.","completed","ExoNET for Supination Assistance in Stroke Survivors","This study is testing a new device called the ExoNET, which is a passive robotic device designed to help stroke survivors move their forearm outwards (supination). Researchers want to see if the ExoNET is safe, practical, and effective in helping your forearm muscles work better and increase your range of motion. You might be able to join if you are between 40 and 70 years old, had a single stroke at least 8 months ago, and have moderate to severe weakness in your arm. The study will look at how well your arm moves using a test called the Action Research Arm Test (ARAT) over three weeks. The current status of this study is unclear.","Participants will be followed for two weeks after the initial baseline evaluation, with assessments at week 2 and week 3.",115,"Participants will have evaluations at week 1 (baseline), week 2 (after treatment), and week 3 (after treatment). During these times, you will perform daily activities while wearing the ExoNET.","Not stated in the trial record.",[],"v2"]