[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07000019":3,"trial-entities:NCT07000019":94,"trial-summary:NCT07000019":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":48,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":14,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":89,"overall_officials":90,"references":92,"see_also_links":93},"NCT07000019","NYMC-25470","Combined Aphasia and Robot-Assisted Arm Treatment for Chronic Stroke Survivors","NOT_YET_RECRUITING","2027-11","2025-05","2025-05-31","2025-06","New York Medical College","OTHER",false,"The goal of this clinical trial is to learn if a program that combines language and arm treatment can improve language and movement problems in people with chronic stroke. The mains questions it aims to answer are:\n\n* To determine the extent to which this combined treatment can improve language.\n* To determine the extent to which the combined treatment can improve arm movements.\n\nResearchers will compare the effects of this combined treatment with treatment that targets arm movements alone.",null,[18,19,20],"Stroke","Aphasia Following Cerebral Infarction","Hemiparesis After Stroke",[22],"stroke, aphasia, hemiparesis, robotic","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},28,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","CARAT: combined aphasia and robot-assisted arm therapy","Participants will receive 18 sessions of robot-assisted arm therapy combined with a standardized picture-word verification therapy task with the goal of improving language and arm movements.",[36],"Combined aphasia and robot-assisted arm treatment",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Robot-assisted arm therapy","Participants will receive 18 sessions of robot-assisted arm therapy with the goal of improving arm movements.",[41],"Robot-assisted arm treatment",[43,46],{"measure":44,"timeFrame":45},"Philadelphia Naming Test","Baseline to 1 week post-treatment",{"measure":47,"timeFrame":45},"Fugl-Meyer Upper Extremity Motor Assessment",[49,52,55,57,59],{"measure":50,"timeFrame":51},"Western Aphasia Battery-Revised Aphasia Quotient","Baseline to 4 weeks post-treatment",{"measure":53,"timeFrame":54},"Box and Blocks Test","Baseline to 1 and 4 weeks post-training",{"measure":56,"timeFrame":54},"Apraxia Battery for Adults",{"measure":58,"timeFrame":54},"Stroke and Aphasia Quality of Life Scale-39",{"measure":60,"timeFrame":54},"Apraxia of Speech Rating Scale","ALL","18 Years","90 Years",{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. Male or female patients between 18-90 years of age.\n2. Right-handed prior to stroke\n3. English-speaking (monolingual)\n4. History of single left-hemisphere stroke at least 6 months prior to enrollment\n5. Presence of aphasia and naming deficits on Western Aphasia Battery (WAB-R)\n6. Comprehension score above 4 on WAB-R\n7. Unilateral upper limb paresis (Fugl-Meyer Upper Extremity score \\\u003C56)\n8. Documentation of signed Informed Consent by the study participant.\n\nExclusion Criteria:\n\n1. Diagnosis or history of speech impairment prior to stroke\n2. Severely limited speech output (score below 2 on spontaneous speech portion of WAB-R)\n3. Inability to perform screening tasks due to severe language and\u002For cognitive impairment\n4. Condition limiting passive movement in the range of motion required for robotic therapy (e.g. fixed contracture)\n5. Any medical or psychiatric condition that may impact participation or compliance with study procedures or activities in the opinion of the investigator",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":86},"Westchester Medical Center \u002F New York Medical College","Valhalla","New York","10595","United States",[79,83],{"name":80,"role":81,"email":82},"Cristina Falo, PhD","CONTACT","cristina.falo@wmchealth.org",{"name":84,"role":85},"Tomoko Kitago, MD","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},41.07482,-73.77513,[],[91],{"name":84,"affiliation":73,"role":85},[],[],{"nct_id":4,"conditions":95,"biomarkers":98},[96,97,18],"Aphasia","Hemiparesis",[],{"nct_id":4,"found":100,"summary":101,"prompt_version":110},true,{"design":102,"status":103,"heading":6,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This study is comparing two treatments in about 28 participants. It's an interventional study, meaning participants will receive a specific treatment.","completed","This study is testing if a treatment called CARAT, which combines language therapy and robot-assisted arm therapy, can help people who have had a stroke improve their language and arm movements. Researchers want to see if CARAT works better than just robot-assisted arm therapy alone. You might be able to join if you are 18-90 years old, right-handed before your stroke, speak English, had a stroke on the left side of your brain at least 6 months ago, and have aphasia (difficulty with language) and problems naming things. The study will measure improvements in naming ability using the Philadelphia Naming Test and arm movement using the Fugl-Meyer Upper Extremity Motor Assessment.","Your language and arm movements will be measured at the start of the study and again one week after your treatment ends.",111,"Participants will receive 18 sessions of either combined aphasia and robot-assisted arm therapy (CARAT) or robot-assisted arm therapy alone.","Not stated in the trial record.",[38],"v2"]