[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635573":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":20,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":20,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":83,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"RxFunction Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Walkasins Users","EXPERIMENTAL","After the baseline visit and activity monitoring, users will receive Walkasins. They will use the device for 10 weeks during which they will also wear an activPAL activity monitor for ten days on at the beginning and end of their Walkasins use.",[13],"Device: External, lower limb sensory prosthesis",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","External, lower limb sensory prosthesis","Walkasins is an external, lower limb sensory prosthesis intended to replace part of the nerve function used for detection and signaling of foot pressure sensation during standing and walking activities. Walkasins consist of two parts for each leg: the Haptic Module and the Receptor Sole. The Haptic Module wraps around the lower leg of the user and contains electronics for reading Receptor Sole pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues to the front, back, medial, and lateral surfaces of the user's leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Sutton B Richmond, PhD","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Dorian Rose, PT, MS, PhD, FAPTA","CONTACT","352-273-8307","research@rxfunction.com",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Hannah Grimes","904-528-3159","Hannah.Grimes@brooksrehab.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Brooks Rehabilitation Center","RECRUITING","Jacksonville","Florida","32216","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-81.65565,30.33218,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":53,"phoneExt":20,"email":30},"Mark B Bowden, PhD","904.345.6626",{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57],{"name":58,"class":59},"Brooks Rehabilitation","OTHER","100635573","wearable-sensory-prosthesis-to-improve-coordination-walking-and-physical-activity-100635573",false,"NCT07554443","Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity","Wearable Sensory Prostheses to Improve Neuromuscular Coordination, Walking Function, and Real-World Physical Activity","Inclusion Criteria:\n\n* Be 60 years of age or older\n* Have a diagnosis of PN with plantar sensory loss\n* Demonstrate balance impairment, defined as a Single-Leg Stance time of \\\u003C23 seconds\n* Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted)\n* Be willing to use the Walkasins device as recommended\n* Be willing to participate in all aspects of physical activity monitoring and study assessments\n\nExclusion Criteria:\n\n* Under 60 years old\n* Do not have a diagnosis of PN with plantar sensory loss\n* Self-reported acute thrombophlebitis, including deep vein thrombosis\n* Self-reported severe peripheral vascular disease\n* Untreated lymphedema\n* Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use\n* Self-reported, untreated fractures in the foot and ankle\n* Other neurological or musculoskeletal conditions that moderately or severely impact walking\n* Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins\n* Weight of more than 300 pounds\n* Inability to perceive vibration from Walkasins Haptic Module\n* Do not demonstrate balance impairments, defined as a Single-Leg Stance time of \\\u003C23 seconds","ALL","60 Years",{"count":70,"type":71},18,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN). The main question it aims to answer is whether Walkasins enhances habitual activity patterns in adults with peripheral neuropathy.\n\nParticipants will do the following as part of the study:\n\n* Complete a sensation and balance assessment to determine eligibility for the study.\n* Answer questions about their medical history, physical function, balance confidence, and sleep.\n* Perform various balance and walking tasks on three separate occasions. One of the tests involves walking for six minutes without a cane or walker.\n* Wear an activPAL activity monitor for ten days on three separate occasions and return it to the researcher as directed.\n* Wear Walkasins for ten weeks as part of their daily routine. Walkasins consists of two parts: 1) an insole that fits inside the shoe and 2) a strap that secures around the ankle.",[77,78,79,80,81,82],"Peripheral Neuropathy With Type 2 Diabetes","Peripheral Neuropathy Grade 2 or Greater","Balance","Balance Impairment, Gait Disorders, Fatigue","Balance Disorders","Physical Activities",[84,85,81,86],"Peripheral Neuropathy","Walkasins","Physical Activity","2026-06-22",{"date":89,"type":90},"2026-06-25","ACTUAL",{"date":89,"type":71},{"date":93,"type":71},"2027-12",{"name":5,"class":6},1]