[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448837":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":12,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":12,"enrollmentInfo":77,"targetDuration":12,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":45,"whyStopped":12,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Washington","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Focus Group Testing","NO_INTERVENTION","Focus group testing of key-fob device to control adjusting socket system",null,{"label":14,"type":15,"description":16,"interventionNames":17},"In-Lab, Crossover Study","EXPERIMENTAL","Testing of auto-adjusting algorithm in-lab. Participants will carry out a structured protocol wearing the socket in all modes. Order will be randomly assigned.",[18],"Device: Auto Adjusting Prosthesis",{"label":20,"type":15,"description":21,"interventionNames":22},"Out-of-Lab Crossover Study","Evaluate socket performance in user free-living environments. Participants will use the prosthesis in all modes by end of study, order will be randomly assigned.",[18],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":12},"DEVICE","Auto Adjusting Prosthesis","Participants will test the auto adjusting prosthesis. The prosthesis will be able to move up to 3 panels built into the socket walls to expand or tighten the socket's fit. The auto adjustments will take place during periods of sitting, standing, or walking. Manual adjustments will also be possible either via the researcher controlling the prosthesis or via the key fob developed in the first aim.",[14,20],[30],{"name":31,"affiliation":5,"role":32},"Joan E Sanders, PhD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":12,"email":38},"Katheryn Allen, CPO","CONTACT","206-390-0228","kate@allyn.org",{"name":40,"role":36,"phone":12,"phoneExt":12,"email":41},"Tessa S Viljamaa","tessasv@uw.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"William H. Foege Hall","RECRUITING","Seattle","Washington","98105","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-122.33207,47.60621,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":37,"phoneExt":12,"email":38},"Katheryn Allyn",{"type":32,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Joan E Sanders","Professor: Engineering",[64],{"name":65,"class":66},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100448837","an-automatically-adjusting-prosthetic-socket-for-people-with-transtibial-amputation-100448837",false,"NCT05124652","An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation","An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation","* 18 years or older\n* Unilateral or bilateral trans-tibial amputation at least 12 months prior\n* Have a limb of length 9 cm or greater\n* Are capable of at least 5 minutes of continuous walking\n* Are capable of at least 1 hour of intermittent walking\n* Regularly use a definitive prosthesis with a pin-lock suspension system and no or few pads\n* Have adequate sensation to verbalize a socket that is too large or too small to be tolerated\n* Do not regularly use assistive devices (e.g., cane, walker) for ambulation\n* Do not have open wounds on their residual limb at the time of enrollment",true,"ALL","18 Years",{"count":78,"type":79},100,"ESTIMATED","INTERVENTIONAL",[82],"NA","People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.",[85,86],"Lower Limb Amputation Below Knee (Injury)","Diurnal Residual Limb Fluid Volume Fluctuation",[88,89],"amputee","prosthetic","2026-05-05",{"date":92,"type":93},"2026-05-07","ACTUAL",{"date":95,"type":93},"2021-10-18",{"date":97,"type":79},"2027-06",{"name":5,"class":6},1]