[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656785":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":43,"studyPopulation":35,"armGroups":44,"interventions":51,"overallOfficials":57,"centralContacts":65,"locations":35,"responsibleParty":73,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":35,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":35,"studyType":91,"phases":92,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":104,"whyStopped":35,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":35},{"fullName":5,"class":6},"Geisinger Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Walking Speed","Walking speed measured during walking trials using timing gates and compared between baseline and vibrotactile feedback conditions.","Single study visit (Day 1)",[14,17,20,23,26,29,32],{"measure":15,"description":16,"timeFrame":12},"Forward Propulsion","Maximum anterior ground reaction force measured during walking trials using force plate data and compared between baseline and vibrotactile feedback conditions.",{"measure":18,"description":19,"timeFrame":12},"Trailing Limb Angle","Trailing limb angle measured during walking trials using motion capture and wearable sensor data and compared between baseline and vibrotactile feedback conditions.",{"measure":21,"description":22,"timeFrame":12},"Ankle Plantarflexion Angle","Peak ankle plantarflexion angle measured during walking trials using motion capture and wearable sensor data and compared between baseline and vibrotactile feedback conditions.",{"measure":24,"description":25,"timeFrame":12},"Gait Symmetry","Symmetry ratio calculated between limbs for trailing limb angle, ankle plantarflexion angle, and forward propulsion during walking trials.",{"measure":27,"description":28,"timeFrame":12},"Lateral Trunk Sway","Magnitude of lateral trunk sway measured during walking trials using motion capture and wearable sensor data and compared between baseline and vibrotactile feedback conditions.",{"measure":30,"description":31,"timeFrame":12},"Timed Up and Go Assessment","Performance on the Timed Up and Go assessment collected during the study visit and used to explore relationships between clinical mobility measures and wearable sensor measurements.",{"measure":33,"description":34,"timeFrame":12},"Berg Balance Scale Assessment","Performance on the Berg Balance Scale assessment collected during the study visit and used to explore relationships between clinical balance measures and wearable sensor measurements",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":35,"timePerspective":35,"maskingInfo":41},"NA","SINGLE_GROUP","All participants will complete the same study procedures during a single study visit and will serve as their own controls. Participants will complete a baseline walking condition followed by vibrotactile feedback conditions targeting trailing limb angle, ankle plantarflexion, and trunk sway. The order of the feedback conditions will be randomized after completion of the baseline condition to reduce potential fatigue and ordering effects.","TREATMENT",{"masking":42,"maskingDescription":35,"whoMasked":35},"NONE","Post-stroke gait rehabilitation frequently targets walking speed because improved walking speed is associated with greater functional mobility and community participation. Forward propulsion is strongly related to walking speed, but the biomechanical concepts commonly targeted in rehabilitation can be difficult for patients to understand and apply during walking. Vibrotactile biofeedback may provide a simple and intuitive method of promoting desirable gait modifications by delivering real-time feedback based on clinically meaningful movement parameters.\n\nThe purpose of this study is to evaluate the immediate effects of vibrotactile feedback on walking biomechanics in individuals with chronic stroke. Specifically, the study will investigate whether vibrotactile feedback can increase walking speed and forward propulsion, improve symmetry of gait-related measures, and reduce lateral trunk sway during walking. The study will also explore the use of wearable inertial measurement units (IMUs) to objectively quantify movement during common clinical mobility and balance assessments.\n\nParticipants will complete a single study visit at the Bucknell University Biomechanics Laboratory. During the visit, motion capture technology, wearable inertial measurement units, timing gates, and force plates will be used to measure walking biomechanics. Participants will complete walking trials under baseline and vibrotactile feedback conditions targeting trailing limb angle, ankle plantarflexion, and trunk sway. Participants will also complete the Timed Up and Go (TUG) assessment and the Berg Balance Scale (BBS).\n\nThe information collected in this study will be used to improve understanding of how vibrotactile feedback can influence gait biomechanics after stroke and may support future development of rehabilitation approaches intended to improve walking function and mobility in stroke survivors.",[45],{"label":46,"type":47,"description":48,"interventionNames":49},"Vibrotactile Feedback Walking Assessment","EXPERIMENTAL","Participants with chronic stroke will complete a single study visit that includes baseline walking assessment, vibrotactile feedback walking conditions targeting trailing limb angle, ankle plantarflexion, and trunk sway, and clinical mobility and balance assessments. All participants will complete all study conditions and serve as their own controls.",[50],"Device: Vibrotactile Feedback System",[52],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":35},"DEVICE","Vibrotactile Feedback System","Participants will receive vibrotactile feedback using a wearable SageMotion system consisting of inertial measurement units mounted on elastic straps. The system calculates joint angles during walking and provides vibration-based feedback when predefined movement goals are achieved. Feedback conditions will target trailing limb angle, ankle plantarflexion, and trunk sway during walking.",[46],[58,61],{"name":59,"affiliation":5,"role":60},"Ryan Roza, MD","PRINCIPAL_INVESTIGATOR",{"name":62,"affiliation":63,"role":64},"Margo Donlin, PhD","Bucknell University","STUDY_DIRECTOR",[66,70],{"name":59,"role":67,"phone":68,"phoneExt":35,"email":69},"CONTACT","570-271-6700","rjroza@geisinger.edu",{"name":62,"role":67,"phone":71,"phoneExt":35,"email":72},"(570) 577-1373","mcd033@bucknell.edu",{"type":74,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[76],{"name":63,"class":77},"UNKNOWN","100656785","vibrotactile-feedback-to-improve-walking-after-stroke-100656785",false,"NCT07831642","Vibrotactile Feedback to Improve Walking After Stroke","Use of Vibrotactile Feedback to Increase Propulsion in Individuals With Chronic Stroke","Inclusion Criteria:\n\n* Age 18 to 85 years\n* Willing and able to provide informed consent\n* Single unilateral stroke at least 6 months prior to enrollment\n* ICD diagnosis code for hemiparesis (I69.35X)\n* Independently ambulatory (cane acceptable; orthosis may require further evaluation)\n* Resting heart rate 40 to 100 beats per minute\n* Resting blood pressure 90\u002F60 to 170\u002F90 mmHg\n* Active hip extension of at least 5 degrees\n* Active ankle dorsiflexion to neutral with the knee extended\n\nExclusion Criteria:\n\n* Evidence of cerebellar stroke\n* Other neurological conditions\n* Lower-limb botulinum toxin injections within the previous 4 months\n* Pain that limits walking\n* Unable to communicate with investigators\n* Signs of unilateral neglect\n* Unexplained dizziness within the previous 6 months\n* Fall within the previous 6 months\n* Congestive heart failure\n* Chronic obstructive pulmonary disease\n* Severe peripheral vascular disease\n* Score greater than 1 on question 1b of the NIH Stroke Scale\n* Score greater than 0 on question 1c of the NIH Stroke Scale\n* Currently pregnant","ALL","18 Years","85 Years",{"count":89,"type":90},32,"ESTIMATED","INTERVENTIONAL",[37],"Stroke survivors often walk more slowly and may have difficulty producing the movements needed to walk efficiently. This study will evaluate whether vibrotactile feedback, delivered through small wearable devices that provide vibrations during walking, can help individuals with chronic stroke change specific walking movements related to walking speed, propulsion, and balance.\n\nParticipants will complete a single study visit at Bucknell University. During the visit, participants will perform several walking trials with and without vibrotactile feedback and will complete common clinical mobility and balance assessments. Motion capture technology and wearable sensors will be used to measure movement during walking.\n\nThe goal of this study is to better understand how vibrotactile feedback can be used to improve walking performance after stroke and to support the future development of rehabilitation approaches for stroke survivors.",[95,96],"Stroke","Hemiparesis",[95,96,98,99,100,10,101,18,102,103],"Vibrotactile Feedback","Biofeedback","Gait Rehabilitation","Propulsion","Trunk Sway","Stroke Rehabilitation","NOT_YET_RECRUITING","2026-09-15",{"date":107,"type":108},"2026-09-21","ACTUAL",{"date":110,"type":90},"2026-11-01",{"date":112,"type":90},"2027-08-31",{"name":5,"class":6}]