[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593821":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":59,"centralContacts":63,"locations":73,"responsibleParty":105,"collaborators":42,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":42,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":42,"enrollmentInfo":116,"targetDuration":42,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":130,"overallStatus":76,"whyStopped":42,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Liberating Technologies, Inc.","INDUSTRY",[8,14,19,24,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Condition A: 4 untargeted channels","EXPERIMENTAL","The 4-channel untargeted condition (Condition A) will utilize every fourth channel, and their location will be targeted at positions that are 'on the 45s' when examining a cross section of the forearm with the elbow bent to 90 degrees and the thumb pointed up.\n\nThis condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.",[13],"Device: Experimental socket with 4 untargeted channels active",{"label":15,"type":10,"description":16,"interventionNames":17},"Condition B: 8 untargeted channels","The 8-channel condition (Condition B) will use the same channels as the 4-channel condition but add the four channels that bisect the original four channels.\n\nThis condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.",[18],"Device: Experimental socket with 8 untargeted channels active",{"label":20,"type":10,"description":21,"interventionNames":22},"Condition C: Up to 16 untargeted channels","The 16-channel untargeted condition (Condition C) will utilize all 16 electrodes. Due to different limb sizes a full singular ring of 16 channels may not be possible on all human subjects. In these situations, the clinicians fabricating will use their best clinical judgement in order to fit as many electrode channels as possible onto the arm. If there is no reasonable way to fit 16 channels within the socket, then the maximum possible number of channels will be placed in the socket and the \"16-channel\" condition will be completed with the maximum number of available channels.\n\nThis condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.",[23],"Device: Experimental socket with up to 16 untargeted channels active",{"label":25,"type":26,"description":27,"interventionNames":28},"Condition D: 8 targeted channels","ACTIVE_COMPARATOR","This socket will use 8 targeted EMG channels identified and marked by the study prosthetist using Coapt's clinical instructions for identifying electrode sites. This condition is conducted and completed during a site visit. Outcome measures will be conducted to assess functional outcomes and self-report measures.",[29],"Device: Experimental socket with 8 targeted channels active",{"label":31,"type":32,"description":33,"interventionNames":34},"At-home Pattern Recognition Practice","OTHER","The subject will use a commercially available EMG Coapt Cuff to practice pattern recognition while at home between study visits. They will be asked to play virtual games with the Coapt Cuff for 15 minutes a day, 3 days a week in between visits. The time between visits will be based on scheduling availability of the participant and study team but is expected to be approximately 1-2 weeks.",[35],"Device: Coapt EMG Cuff",[37,43,47,51,55],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DEVICE","Experimental socket with 4 untargeted channels active","Participants will utilize the experimental socket made with untargeted EMG channels. Untargeted sites will ideally be located by creating a band of electrode pairs at the largest muscular circumference distal to the elbow. Only 4 channels will be active during this condition.",[9],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Experimental socket with 8 untargeted channels active","Participants will utilize the experimental socket made with untargeted EMG channels. Untargeted sites will ideally be located by creating a band of electrode pairs at the largest muscular circumference distal to the elbow. Only 8 channels will be active during this condition.",[15],{"type":38,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Experimental socket with up to 16 untargeted channels active","Participants will utilize the experimental socket made with untargeted EMG channels. Untargeted sites will ideally be located by creating a band of electrode pairs at the largest muscular circumference distal to the elbow. All16 channels (or the maximum number of channels based on limb size) will be active during this condition.",[20],{"type":38,"name":52,"description":53,"armGroupLabels":54,"otherNames":42},"Experimental socket with 8 targeted channels active","Participants will utilize the experimental socket made with targeted EMG channels. This socket will follow Coapt's clinical instructions for targeted site location to identify and mark locations for 8 targeted EMG channels.",[25],{"type":38,"name":56,"description":57,"armGroupLabels":58,"otherNames":42},"Coapt EMG Cuff","This device is the commercially available Coapt EMG Cuff. This armband cuff with electrodes can be strapped onto the user's arm to connect with the Coapt app and play virtual games with their EMG signals.",[31],[60],{"name":61,"affiliation":5,"role":62},"Todd Farrell, PhD","PRINCIPAL_INVESTIGATOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":42,"email":68},"Brianna Rozell","CONTACT","774-233-0876","brianna.rozell@liberatingtech.com",{"name":70,"role":66,"phone":71,"phoneExt":42,"email":72},"Craig Kelly","774.233.0878","craig.kelly@liberatingtech.com",[74,93],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Shirley Ryan AbilityLab","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-87.65005,41.85003,{"lat":86,"lon":85},[89],{"name":90,"role":66,"phone":91,"phoneExt":42,"email":92},"Laura Miller, PhD","312-238-1000","lmiller1@sralab.org",{"facility":5,"status":94,"city":95,"state":96,"zip":97,"country":80,"countryCode":81,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"NOT_YET_RECRUITING","Holliston","Massachusetts","01746",{"type":83,"coordinates":99},[100,101],-71.4245,42.2001,{"lat":101,"lon":100},[104],{"name":65,"role":66,"phone":67,"phoneExt":42,"email":68},{"type":106,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100593821","effects-of-myoelectric-channel-count-and-targeting-for-upper-limb-prosthetic-control-100593821",false,"NCT07011420","Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control","Evaluation of Functional Performance of Persons With Limb Differences to Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis","Inclusion Criteria:\n\n* Unilateral transradial level limb absence\n* Current or past user of myo-electric controlled prostheses\n* Six months or more post-amputation\n* Have adequate limb length such that a wrist rotation device can fit in the check socket\n* Well-fitting socket as determined by a Socket-Comfort Score of 6 or above\n* Capable of wearing and operating a prosthesis with a wrist rotator and multi-articulating hand\n* Capable of understanding and following multi-step instructions and completing the tasks as described\n* English speaking\n\nExclusion Criteria:\n\n* Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.\n* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.","ALL","18 Years",{"count":117,"type":118},32,"ESTIMATED","INTERVENTIONAL",[121],"NA","The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years or older with upper limb absence at the transradial level while wearing a physical prosthesis.\n\nThe specific aims of this study are:\n\n1. To evaluate the effect of changing untargeted myoelectric channel count on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.\n2. To evaluate the effect of changing myoelectric channel targeting of a fixed number of myoelectric channels on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.\n\nResearchers will perform a randomized crossover study to compare system configurations with different number of sensor channels and with various strategies for sensor placement on the limb. Participants will be assigned to a random test sequence that includes the following four different EMG channel conditions:\n\nCondition A: 4 untargeted channels Condition B: 8 untargeted channels Condition C: Up to 16 untargeted channels Condition D: 8 targeted channels\n\nResearchers will evaluate the effects of changing myoelectric channel counts on the functional prosthesis performance of individuals with transradial limb loss via functional outcome measures.\n\nParticipants will:\n\n* Attend up to 5 in-lab sessions that are expected to last 4 hours.\n* Conduct site visits every 1-2 weeks to complete functional and self reported outcome measures with each condition.\n* Play virtual games with the Coapt Cuff for 15 minutes a day, 3 days a week in between visits.",[124,125,126,127,128,129],"Amputation","Amputation, Traumatic","Amputation, Congenital","Prosthesis User","Upper Limb Amputation Below Elbow (Injury)","Amputation; Traumatic, Arm: Forearm, Between Elbow and Wrist",[131,132,133,134,135],"amputee","upper limb amputee","transradial amputee","prosthetic arm","upper limb prosthesis user","2025-09-02",{"date":138,"type":139},"2025-09-03","ACTUAL",{"date":141,"type":118},"2025-10",{"date":143,"type":118},"2026-06",{"name":5,"class":6},2]