[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06213272":3,"trial-entities:NCT06213272":131,"trial-summary:NCT06213272":135},{"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":22,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":53,"secondary_outcomes":74,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":99,"locations":102,"central_contacts":117,"overall_officials":125,"references":129,"see_also_links":130},"NCT06213272","R-1242-23","Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits","Improving Reading Competence in Aphasia With Combined Aerobic Exercise and Phono-Motor Treatment","RECRUITING","2029-03-01","2026-08","2026-08-13","2024-04-18","Kessler Foundation","OTHER",true,"The goal of the proposed project is to test the effectiveness of a novel hybrid approach to treatment of reading disorders after stroke, in which exercise training will be used in combination with a targeted reading treatment. This approach is expected to increase cerebral circulation and help to rebuild and strengthen the damaged phonological neural networks. Through this combinatory approach, the study aims to enhance the reading and language improvements seen with existing treatments.","Close to 2.5 million Americans are currently living with post-stroke aphasia, a debilitating communication disorder affecting multiple language modalities. Most stroke survivors with aphasia have acquired reading deficits, which persist chronically and severely limit life participation and autonomy. There is an urgent need for effective treatments grounded in stroke neurobiology which yield robust functional improvements. This project is a randomized controlled trial, which will recruit 70 individuals with chronic left-hemisphere stroke. Participants will complete 40 sessions of targeted reading treatment combined with either 20 minutes of moderate aerobic exercise or light stretching. Participants will undergo 3 Magnetic Resonance Imaging (MRI) scans, administered before the intervention, after the initial exercise session, and after the full course of treatment. They will also complete behavioral testing before and after the intervention. The outcome of this study has the potential to radically change how reading treatments are applied, increasing their effectiveness, and ultimately improving the lives of 2.5 million Americans living with stroke-related aphasia. In addition, it is likely that the results will contribute to the understanding of stroke recovery mechanisms thereby fundamentally advancing the field of neurorehabilitation.",[19,20,21],"Stroke","Aphasia","Reading Disorder",[23,24,25,26,27,28,29],"exercise","stroke","aphasia","reading therapy","phono-motor therapy","aerobic exercise treatment","MRI","INTERVENTIONAL","TREATMENT",[33],"NA",{"count":35,"type":36},70,"ESTIMATED",[38,45,49],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","Phono-Motor Therapy","The goal of PMT is to build orthographic and phonological awareness and phonological sequence knowledge. During PMT, participants will complete a series of tasks manipulating minimal sound units (consonants (C) \\& vowels (V)), combining these units into syllables (CVC, CVCC, CCVC) and syllable sequences (real words and readable nonwords). PMT will aim to engage 5 modalities: visual, acoustic, tactile kinesthetic, motor, and orthographic. Multisyllabic stimuli used during treatment will consist of 40 real words and 68 readable nonword letter strings.",[43,44],"Aerobic Exercise Treatment (AET) combined with Phono-Motor Therapy (PMT)","Stretching and PMT",{"type":39,"name":46,"description":47,"armGroupLabels":48},"Aerobic Exercise Training (AET)","Stationary ergometer cycling at 60% heart rate range for 20 minutes, plus 5 minutes of warm up and cool down.",[43],{"type":39,"name":50,"description":51,"armGroupLabels":52},"Stretching","Light stretching activities targeting the head\u002Fneck, shoulder, elbow\u002Fforearm, hand\u002Fwrist, trunk\u002Fhip, ankle\u002Ffoot.",[44],[54,58,61,64,68,71],{"measure":55,"description":56,"timeFrame":57},"Reading Aloud","Participants will read aloud 120 words and 80 nonwords, some of which will be selected for PMT based on individual accuracy (treated items). A subset of these will not be treated and will be used to assess generalization.","Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)",{"measure":59,"description":60,"timeFrame":57},"2 Alternative Forced Choice Computer Tasks","Touch-screen computer tests of semantics, phonology, \\& orthography (composite score).\n\nParticipants choose one of two examples on the screen that matches a target in meaning (semantics), rhymes with the target (phonology), or chose a letter string that more closely resembles a word.",{"measure":62,"description":63,"timeFrame":57},"Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2)","Letter, word, sentence, paragraph, and text-level reading comprehension test for aphasia.",{"measure":65,"description":66,"timeFrame":67},"Cerebral Blood Flow (CBF)","CBF will be measured using an Arterial Spin Labeling MRI sequence","Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)",{"measure":69,"description":70,"timeFrame":67},"Resting State Functional Connectivity (rsFC)","RsFC will be measured using fMRI acquired with rapid simultaneous multi-slice echo-planar imaging (EPI) (TR=1.5s, TE=30ms, 44 slices, gap = .5mm, 2mm isotropic voxels, N volumes=400, eyes open). To standardize the rest condition across participants, we will instruct participants to look at a centrally presented fixation dot for the duration of the scan.",{"measure":72,"description":73,"timeFrame":57},"Task-induced fMRI activation","Data will be collected using fMRI sequence above. Participants will perform a reading aloud task where words or nonwords are presented on the screen one at a time. The order of reading blocks (words\u002Fnonwords) will be randomized (9 blocks of each\\*2 runs). Each 32 s reading block will have 8 words (blocked by condition, e.g., high imagery, frequency, and consistency) or nonwords, presented for 1 s and followed by \\~3s response period. The onset of each word or nonword stimulus will be randomly jittered by 100-400ms to provide the ability to model errors. Voice responses will be collected via an MR microphone (FOMRI III+, Optoacoustics) and used to score reading accuracy. Reading aloud accuracy will be evaluated by 2 independent raters, and disagreements will be resolved by discussion. The reading aloud blocks will be alternated with baseline fixation blocks (12s) and rest blocks (8s) for a total duration of 52s for each block cycle (7.8 min run)",[75,78],{"measure":76,"description":77,"timeFrame":57},"Western Aphasia Battery Revised","A comprehensive assessment of language impairments in aphasia",{"measure":79,"description":80,"timeFrame":57},"Philadelphia Naming Test (Short)","A 30-tem picture naming test designed to identify word finding difficulties. It is presented on a computer using line drawn images of animate and inanimate objects and is audio recorded.","ALL","18 Years","85 Years",false,{"inclusion":86,"exclusion":92,"raw_text":98},[87,88,89,90,91],"fluent and literate in English prior to stroke","1st ever stroke","more than 3 months post-stroke","post-stroke reading deficits, defined as reading aloud accuracy \\\u003C83% for single words or \\\u003C65% for readable nonwords","living within a 50-mile radius from Kessler Foundation.",[93,94,95,96,97],"contraindication to MRI","prior neurological disease","developmental learning or reading disability (i.e., developmental dyslexia)","contraindication to exercise","concurrent speech and language therapy","Inclusion Criteria:\n\n* fluent and literate in English prior to stroke\n* 1st ever stroke\n* more than 3 months post-stroke\n* post-stroke reading deficits, defined as reading aloud accuracy \\\u003C83% for single words or \\\u003C65% for readable nonwords\n* living within a 50-mile radius from Kessler Foundation.\n\nExclusion Criteria:\n\n* contraindication to MRI\n* prior neurological disease\n* developmental learning or reading disability (i.e., developmental dyslexia)\n* contraindication to exercise\n* concurrent speech and language therapy",[100,101],"ADULT","OLDER_ADULT",[103],{"facility":13,"status":8,"city":104,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":114},"West Orange","New Jersey","07052","United States",[109],{"name":110,"role":111,"phone":112,"email":113},"Olga Boukrina, Ph.D.","CONTACT","9733243587","oboukrina@kesslerfoundation.org",{"lat":115,"lon":116},40.79871,-74.23904,[118,121],{"name":119,"role":111,"phone":120,"email":113},"Olga Boukrina, PhD","19733243587",{"name":122,"role":111,"phone":123,"email":124},"Matthew R Weiner","973-323-3745","mweiner@kesslerfoundation.org",[126],{"name":127,"affiliation":13,"role":128},"Olga Boukrina","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":132,"biomarkers":134},[20,133,19],"Developmental reading disorder",[],{"nct_id":4,"found":15,"summary":136,"prompt_version":145},{"design":137,"status":138,"heading":6,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This is an interventional, randomized controlled trial planning to enroll 70 participants.","completed","This study is testing a new way to help people with reading difficulties (reading deficits) after a stroke. It combines a special reading treatment called Phono-Motor Therapy (PMT) with either aerobic exercise (like cycling) or light stretching. The goal is to see if adding exercise can improve reading and language skills more than PMT alone. Researchers believe exercise might increase blood flow to the brain, helping to repair damaged areas. You might be able to join if you are 18-85 years old, had your first stroke more than three months ago, have reading difficulties, and live within 50 miles of Kessler Foundation. The study will measure reading aloud, computer tasks, and reading comprehension to see if the treatments are successful. The current status of this study is unclear.","Your reading abilities will be measured within two weeks of completing treatment, which is about 10 weeks from the start of the study.",128,"You would complete 40 sessions of treatment, along with three MRI scans and behavioral tests before and after the intervention.","Not stated in the trial record.",[40,50],"v2"]