[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06786858":3,"trial-entities:NCT06786858":95,"trial-summary:NCT06786858":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":66,"locations":69,"central_contacts":85,"overall_officials":88,"references":93,"see_also_links":94},"NCT06786858","00004431","Hand Exoskeleton Training Study","Home Training for Upper Limb Stroke Rehabilitation Using a Hand Exoskeleton","RECRUITING","2025-01-31","2025-01","2025-01-22","2022-01-04","Medstar Health Research Institute","OTHER",false,"The goal of this study is to evaluate the HandMATE device's effectiveness in the rehabilitation of stroke patients and asses if the HandMATE application is received well by stroke survivors.\n\nParticipants will use the HandMate device in clinic and in the home. They will also complete clinical upper extremity assessments.","This study will evaluate the effectiveness of novel device and its potential to help stroke victims regain functional use of their hand and regain independent living. The study will also evaluate the potential of the device to be used at home, this would allow increased therapy intensity and decreased overall treatment costs (fewer therapist hours required and decreased travel costs).",[19],"Stroke",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},15,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","HandMate","HandMate device is used for 20 hours in 4 weeks. Device is then used in the home for 3 months at discretion of participant.",[33],"HandMate Use",[35,39,43],{"measure":36,"description":37,"timeFrame":38},"Fugl-Meyer Upper Extremity (FMA-UE) Test","Evaluates and measures recovery in post-stroke hemiplegic patients. The FMA-UE Test will assess upper limb motor impairments for this study. It is a 33-item test that measures motor and reflex function in the upper body. Each item is scored on a scale of 0-2, with 0 indicating inability, 1 indicating beginning ability, and 2 indicating normal. The total score ranges from 0-66, highest score indicating no disability.","Change from baseline Fugl-Meyer score at 6 weeks",{"measure":40,"description":41,"timeFrame":42},"Action Research Arm Test (ARAT)","The ARAT is 19-item clinical assessment used to measure the functional ability of the upper extremity, particularly in individuals recovering from a stroke, by evaluating their performance on tasks like grasping, gripping, pinching, and gross arm movements. It is scored on a four-level ordinal scale (0-3). Highest score indicating normal movement.","Change from baseline ARAT score at 6 weeks",{"measure":44,"description":45,"timeFrame":46},"Motor Activity Log","The Motor Activity Log will be used to assess use of the limb at home. Respondents rate how they use their more-impaired arm for activities of daily living (ADLs) in the home (brushing teeth, buttoning a shirt, etc.).","Change from baseline MAL score at 6 weeks",[],"ALL","21 Years",null,{"inclusion":52,"exclusion":58,"raw_text":65},[53,54,55,56,57],"Age of 21 or older","diagnosis of stroke more than 6 months prior confirmed from MRI or CT","voluntary hand activity (score of 1 or more, finger extension item, Fugl-Meyer Test)","adequate cognitive status","Impaired ability to open affected hand",[59,60,61,62,63,64],"hemispatial neglect","severe sensory loss (2 or more on the sensory item, NIH Stroke Scale\u002FScore)","receiving or planning to receive antispasticity medications during enrollment into the study","less than full passive range of motion in finger joints","receiving physical or occupational therapy outside of study protocols","have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols","Inclusion Criteria:\n\n* Age of 21 or older\n* diagnosis of stroke more than 6 months prior confirmed from MRI or CT\n* voluntary hand activity (score of 1 or more, finger extension item, Fugl-Meyer Test)\n* adequate cognitive status\n* Impaired ability to open affected hand\n\nExclusion Criteria:\n\n* hemispatial neglect\n* severe sensory loss (2 or more on the sensory item, NIH Stroke Scale\u002FScore)\n* receiving or planning to receive antispasticity medications during enrollment into the study\n* less than full passive range of motion in finger joints\n* receiving physical or occupational therapy outside of study protocols\n* have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"MedStar National Rehabilitation Hospital","Washington D.C.","District of Columbia","20010","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Megan L Grainger","CONTACT","202-877-1464","megan.l.grainger@medstar.net",{"lat":83,"lon":84},38.89511,-77.03637,[86],{"name":78,"role":79,"phone":87,"email":81},"2028771464",[89],{"name":90,"affiliation":91,"role":92},"Pete Lum, PhD","MedStar RI","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":97},[19],[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an interventional study planning to enroll 15 participants. The phase of the study is not specified.","completed","Hand Exoskeleton Training Study for Stroke Recovery","This study is testing a device called HandMate to see if it can help people who have had a stroke regain movement in their hand. Participants will use the HandMate device for 20 hours over 4 weeks in a clinic, and then can choose to use it at home for 3 months. The study aims to see how well the HandMate helps improve hand function and if stroke survivors find it easy to use. To join, you must be 21 or older, have had a stroke at least 6 months ago, and have some voluntary hand movement but also difficulty opening your affected hand. The study plans to enroll 15 participants, but its current status is unclear.","Your hand function will be measured at 6 weeks after starting the study.",117,"You would use the HandMate device for 20 hours over 4 weeks in a clinic, and then potentially at home for 3 months. You will also complete clinical assessments of your upper arm and hand.","Not stated in the trial record.",[30],"v2"]