[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100277824":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":63,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":68,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Spaulding Rehabilitation Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SynPhNe therapy","EXPERIMENTAL","Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes with SynPhNe platform, over 6 weeks. The sessions will emphasize wrist and fingers movements, including functional activities.\n\nDuring week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. Over the next 4 to 5 weeks, 10 sessions following exercises prompted by the SynPhNe system will be done unsupervised at home (or under limited supervision at the hospital), 2 sessions will be done at Spaulding Rehabilitation Hospital to review exercises with the SynPhNe system.\n\nOver the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage.",[13],"Device: SynPhNe platform",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional therapy","ACTIVE_COMPARATOR","Subjects will be asked to participate in a program of 18 upper-extremity rehabilitation sessions of 60 minutes under therapist supervision over two weeks at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The sessions will emphasize wrist and fingers movements, including functional activities.\n\nDuring week the two first weeks, 6 sessions will be done under therapist supervision at the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital. The remaining 10 sessions will be done unsupervised at home, over approximately 4 weeks, and following the therapist home treatment plan. Over that time, 2 visits to Spaulding Rehabilitation will be made to review home treatment plan. Over the course of the study, participants will wear Axivity sensors to gather information about upper-extremity usage.",[19],"Other: Conventional therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","SynPhNe platform","SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head component and it communicates wirelessly with the computer to provide feedback while performing motor tasks with the hemiparetic hand. The head cap records brain activity and gives feedback to help relaxing while exercising. The arm and the head component communicate wirelessly with the computer via Bluetooth. The head component reads brain signals while the arm gear senses your muscle signals when performing the exercises. The computer software adopts the appropriate difficulty level, speed and duration of the exercise depending on brain and muscle status to minimize fatigue.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Exercise program established with a therapist (8 sessions under therapist direct supervision and 10 sessions at home). Low functioning subjects will be given more proximal joint-muscle exercises and activities while higher functioning subjects will have a greater component of distal tasks and activities. The therapist will review the exercises therapy plan with the subject and re-adjust it.",[15],[31],{"name":32,"affiliation":5,"role":33},"Paolo Bonato, PhD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Kathy Piela, PT, DPT","CONTACT","6179526388","kpiela@mgb.org",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":26},"Motion Analysis Laboratory","6179526331",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Boston","Massachusetts","02129","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.05977,42.35843,{"lat":55,"lon":54},[58,60,62],{"name":36,"role":37,"phone":59,"phoneExt":26,"email":39},"617-952-6388",{"name":41,"role":37,"phone":61,"phoneExt":26,"email":26},"617-952-6331",{"name":32,"role":33,"phone":26,"phoneExt":26,"email":26},{"type":33,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Paolo Bonato","PhD","100277824","assessment-of-a-physio-neuro-platform-synphne-for-home-based-retraining-of-hand-function-in-stroke-survivors-100277824",false,"NCT02896348","Assessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors","Inclusion Criteria:\n\n* Ischemic or hemorrhagic stroke at least 6 months prior study enrollment ;\n* Moderate upper-extremity hemiparesis (initial score on the Upper Extremity Fugl-Meyer Assessment between 21 and 55 out of 66) ;\n* Ability to extend at least 2 fingers in the affected hand 10 degrees at any joint with pain-free passive range of motion at least 50% in all joints below the elbow.\n\nExclusion Criteria:\n\n* Cognitive impairment resulting to inability to follow instructions (as assessed with the MMSE) and inability to sustain attention for more than 10 minutes;\n* Current participation in upper-extremity therapy program;\n* Treatment with Botox injections in the affected arm in the previous 3 months and no planned Botox injections before the end of the study;\n* Aphasia sufficient to limit comprehension and completion of the treatment protocol;\n* No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy;\n* Increased muscle tone as indicated by score of \\>\u002F= 3 on the Modified Ashworth Scale;\n* Previous diagnosis of dementia;\n* Previous diagnosis of neurological diseases other than Stroke;\n* History of seizures disorder and\u002For a seizure occuring within the last 6 months;\n* Other conditions affecting function of the stroke affected upper limb;\n* Severe pain in the stroke affected upper limb;\n* Terminal diseases with expected survival \\\u003C1 year;","ALL","21 Years","80 Years",{"count":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this study is to:\n\n1. Assess the usability of the SynPhNe device in a home environment.\n2. Evaluate the efficacy of the SynPhNe home use device to improve motor hand function in chronic stroke subjects as compared to standard care alone.",[83,84],"Stroke","Hemiparesis",[84,83,86,87],"Rehabilitation","Home-based","2026-05-04",{"date":90,"type":91},"2026-05-06","ACTUAL",{"date":93,"type":91},"2025-02-26",{"date":95,"type":77},"2027-03",{"name":5,"class":6},1]