[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655016":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":81,"studyPopulation":71,"armGroups":82,"interventions":133,"overallOfficials":168,"centralContacts":172,"locations":71,"responsibleParty":178,"collaborators":71,"id":180,"slug":181,"hasResults":182,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":71,"eligibilityCriteria":186,"healthyVolunteers":182,"sex":187,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":71,"studyType":193,"phases":194,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":208,"whyStopped":71,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":71},{"fullName":5,"class":6},"Chang Gung Memorial Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":71},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Trail Making Test-Part B (TMT-B)","The TMT-B assesses executive function and cognitive flexibility. Longer completion times indicate poorer executive function and cognitive flexibility.","Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).",{"measure":14,"description":15,"timeFrame":12},"Intra-Extra Dimensional Shift (IED)","The IED assesses set-shifting ability and cognitive flexibility. Fewer errors indicate better performance.",{"measure":17,"description":18,"timeFrame":12},"Rapid Visual Information Processing (RVP)","The RVP assesses sustained attention. Higher accuracy indicates better sustained attention.",{"measure":20,"description":21,"timeFrame":12},"Digit Span Test","The Digit Span Test assesses working memory and sustained attention. Higher span scores indicate stronger working memory and sustained attention.",{"measure":23,"description":24,"timeFrame":12},"Fugl-Meyer Assessment-Upper Extremity (FMA-UE)","The FMA-UE assesses upper-extremity motor control. Scores range from 0 to 66, with higher scores indicating better motor control.",{"measure":26,"description":27,"timeFrame":12},"Action Research Arm Test (ARAT)","The ARAT assesses upper-limb functional performance. Scores range from 0 to 57, with higher scores indicating better upper-limb function.",[29,32,35,38,41,44,47,50,53,56,59,62,65,68],{"measure":30,"description":31,"timeFrame":12},"Montreal Cognitive Assessment (MoCA)","The MoCA assesses cognitive functioning across domains including attention, executive function, memory, and visuospatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.",{"measure":33,"description":34,"timeFrame":12},"Trail Making Test-Part A (TMT-A)","The TMT-A assesses processing speed and attention. Longer completion times indicate poorer processing speed and attention.",{"measure":36,"description":37,"timeFrame":12},"Symbol Digit Modalities Test (SDMT)","The SDMT assesses processing speed. More correct responses indicate better processing speed.",{"measure":39,"description":40,"timeFrame":12},"Spatial Working Memory (SWM)","The SWM assesses working memory. Fewer errors indicate better working memory performance.",{"measure":42,"description":43,"timeFrame":12},"Paired Associates Learning (PAL)","The PAL assesses visual learning. Fewer errors indicate better visual learning performance.",{"measure":45,"description":46,"timeFrame":12},"Modified Ashworth Scale (MAS)","The MAS assesses muscle spasticity. Scores range from 0 to 4, with higher scores indicating greater spasticity.",{"measure":48,"description":49,"timeFrame":12},"Grip and Pinch Dynamometry","Grip and pinch dynamometry measures upper-extremity muscle strength. Higher force output indicates greater muscle strength.",{"measure":51,"description":52,"timeFrame":12},"Box and Block Test (BBT)","The BBT assesses gross manual dexterity. More blocks transferred indicate better gross manual dexterity.",{"measure":54,"description":55,"timeFrame":12},"Nine-Hole Peg Test (9HPT)","The 9HPT assesses fine motor coordination. Shorter completion times indicate better fine motor coordination.",{"measure":57,"description":58,"timeFrame":12},"Motor Activity Log (MAL)","The MAL assesses use of the affected arm in daily activities and perceived quality of movement. Scores range from 0 to 5, with higher ratings indicating greater daily arm use and better movement quality.",{"measure":60,"description":61,"timeFrame":12},"ABILHAND Questionnaire","The ABILHAND Questionnaire assesses perceived manual ability in daily activities. Higher logit scores indicate better perceived manual ability.",{"measure":63,"description":64,"timeFrame":12},"Functional Independence Measure (FIM)","The FIM assesses functional independence. Scores range from 18 to 126, with higher scores indicating greater functional independence.",{"measure":66,"description":67,"timeFrame":12},"Stroke Impact Scale (SIS)","The SIS assesses the impact of stroke on functional recovery. Domain scores range from 0 to 100, with higher scores indicating better functional recovery.",{"measure":69,"description":70,"timeFrame":12},"Stroke-Specific Quality of Life Scale (SS-QOL)","The SS-QOL assesses stroke-specific health-related quality of life. Higher scores indicate better health-related quality of life.",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":71,"primaryPurpose":75,"observationalModel":71,"timePerspective":71,"maskingInfo":76},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":77,"maskingDescription":71,"whoMasked":78},"DOUBLE",[79,80],"PARTICIPANT","OUTCOMES_ASSESSOR","This is a three-stage, randomized, sham-controlled study in individuals after stroke. Stage 1 will compare FES cycling alone, FES cycling combined with cognitive task training, and sham FES cycling. Stage 2 will compare photobiomodulation applied to the ear, forehead, and sham stimulation. Stage 3 will evaluate the selected FES cycling and neuromodulation approaches alone and in combination. Participants will complete 10 sessions over 2 weeks. Cognitive, upper-extremity motor, functional, participation, and quality-of-life outcomes will be assessed at baseline, immediately after treatment, and at 3-month follow-up. Feasibility, adherence, tolerance, and adverse events will also be monitored.",[83,89,94,100,105,110,115,120,125,129],{"label":84,"type":85,"description":86,"interventionNames":87},"Stage 1: FES Cycling Alone","EXPERIMENTAL","Participants receive FES-assisted arm cycling.",[88],"Device: Functional Electrical Stimulation Cycling",{"label":90,"type":85,"description":91,"interventionNames":92},"Stage 1: Dual-Task FES Cycling","Participants receive FES-assisted arm cycling combined with cognitive task training.",[88,93],"Behavioral: Cognitive Task Training",{"label":95,"type":96,"description":97,"interventionNames":98},"Stage 1: Sham FES Cycling","PLACEBO_COMPARATOR","Participants receive sham FES cycling.",[99],"Device: Sham Functional Electrical Stimulation Cycling",{"label":101,"type":85,"description":102,"interventionNames":103},"Stage 2: Auricular Photobiomodulation","Participants receive transcutaneous auricular photobiomodulation (taPBM).",[104],"Device: Transcutaneous Auricular Photobiomodulation",{"label":106,"type":85,"description":107,"interventionNames":108},"Stage 2: Forehead Photobiomodulation","Participants receive transcutaneous forehead photobiomodulation (tfPBM).",[109],"Device: Transcutaneous Forehead Photobiomodulation",{"label":111,"type":96,"description":112,"interventionNames":113},"Stage 2: Sham Photobiomodulation","Participants receive sham photobiomodulation.",[114],"Device: Sham Photobiomodulation",{"label":116,"type":85,"description":117,"interventionNames":118},"Stage 3: Optimal FES Cycling + Sham Neuromodulation","Participants receive the optimal FES cycling protocol identified in Stage 1 combined with sham neuromodulation.",[114,119],"Other: Optimal FES Cycling Protocol",{"label":121,"type":85,"description":122,"interventionNames":123},"Stage 3: Optimal Neuromodulation + Sham FES Cycling","Participants receive the optimal neuromodulation protocol identified in Stage 2 combined with sham FES cycling.",[99,124],"Device: Optimal Neuromodulation Protocol",{"label":126,"type":85,"description":127,"interventionNames":128},"Stage 3: Optimal FES Cycling + Optimal Neuromodulation","Participants receive the optimal FES cycling protocol combined with the optimal neuromodulation protocol.",[119,124],{"label":130,"type":96,"description":131,"interventionNames":132},"Stage 3: Sham FES Cycling + Sham Neuromodulation","Participants receive sham FES cycling combined with sham neuromodulation.",[99,114],[134,139,144,148,152,156,160,164],{"type":135,"name":136,"description":137,"armGroupLabels":138,"otherNames":71},"DEVICE","Functional Electrical Stimulation Cycling","FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks.",[90,84],{"type":140,"name":141,"description":142,"armGroupLabels":143,"otherNames":71},"BEHAVIORAL","Cognitive Task Training","Cognitive tasks are performed during FES cycling and progressively target attention, working memory, and executive control.",[90],{"type":135,"name":145,"description":146,"armGroupLabels":147,"otherNames":71},"Transcutaneous Auricular Photobiomodulation","Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes.",[101],{"type":135,"name":149,"description":150,"armGroupLabels":151,"otherNames":71},"Transcutaneous Forehead Photobiomodulation","Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes.",[106],{"type":135,"name":153,"description":154,"armGroupLabels":155,"otherNames":71},"Sham Functional Electrical Stimulation Cycling","Participants receive the sham FES cycling control condition.",[95,121,130],{"type":135,"name":157,"description":158,"armGroupLabels":159,"otherNames":71},"Sham Photobiomodulation","Participants receive the sham photobiomodulation control condition.",[111,116,130],{"type":6,"name":161,"description":162,"armGroupLabels":163,"otherNames":71},"Optimal FES Cycling Protocol","The FES cycling condition associated with the most favorable cognitive-motor performance pattern in Stage 1 will be selected for use in Stage 3. The selected protocol will consist of either FES cycling alone or FES cycling combined with cognitive task training.",[126,116],{"type":135,"name":165,"description":166,"armGroupLabels":167,"otherNames":71},"Optimal Neuromodulation Protocol","The photobiomodulation condition associated with the most favorable cognitive-motor performance pattern in Stage 2 will be selected for use in Stage 3. The selected protocol will consist of either transcutaneous auricular photobiomodulation (taPBM) or transcutaneous forehead photobiomodulation (tfPBM).",[126,121],[169],{"name":170,"affiliation":5,"role":171},"Chia-Ling Chen","STUDY_DIRECTOR",[173],{"name":170,"role":174,"phone":175,"phoneExt":176,"email":177},"CONTACT","+883-3-3281200","8148","clingchen@gmail.com",{"type":179,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR","100655016","neuromodulation-combined-with-dual-fes-cycling-and-cognitive-training-after-stroke-100655016",false,"NCT07807176","Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke","Exploratory Evaluation of Neuromodulation Combined With Dual Functional Electrical Stimulation Cycling and Cognitive Task Training on Cognitive-Motor Performance in Individuals After Stroke","Inclusion Criteria:\n\n* Adults aged 20 to 80 years.\n* First-ever ischemic or hemorrhagic stroke with unilateral impairment in hand or arm strength or motor function.\n* Medically stable and able to participate safely in the training program.\n* Able to understand the study procedures and sign the informed consent form.\n* Able to follow verbal instructions, comply with study procedures, and complete all assessments.\n* Able to maintain a seated position and participate in each training session (approximately 40-60 minutes).\n\nExclusion Criteria:\n\n* Stroke involving the brainstem or cerebellum.\n* History of epilepsy, photosensitive epilepsy, or a tendency to faint.\n* Presence of implanted electronic devices, such as pacemakers, implantable cardioverter-defibrillators (ICD), or other electronic medical implants (e.g., artificial heart, infusion pumps, cochlear implants).\n* Wounds, infections, or significant skin problems at potential stimulation sites (ear or scalp).\n* Presence of major psychiatric disorders or inability to understand or cooperate with testing.\n* Cardiovascular or vascular-related conditions, including severe heart disease, uncontrolled arrhythmia, or medical advice against exercise; use of anticoagulant medication that makes laser stimulation inappropriate.\n* Acute illness, such as fever or active infection.\n* Botulinum toxin injections or relevant surgeries within the past six months.\n* Photosensitive disorders (e.g., lupus, porphyria) or current use of photosensitizing medications.\n* Inability to safely perform cycling training (e.g., recent fractures, severe spasticity, difficulty maintaining seated posture).\n* Pregnant or breastfeeding individuals.\n* Any other condition deemed unsuitable by the study physician (e.g., severe claustrophobia).","ALL","20 Years","80 Years",{"count":191,"type":192},150,"ESTIMATED","INTERVENTIONAL",[195],"NA","This study will evaluate the effects of functional electrical stimulation (FES) cycling, cognitive task training, and non-invasive photobiomodulation on cognitive and upper-limb motor performance in adults after stroke. The study includes three stages to identify favorable FES cycling and neuromodulation approaches and to evaluate their combined effects. Participants will complete 10 intervention sessions over 2 weeks. Cognitive and motor outcomes will be assessed before treatment, immediately after treatment, and at 3-month follow-up. Feasibility, tolerance, and adverse events will also be evaluated.",[198],"Stroke",[200,201,202,203,141,204,205,206,207],"Functional Electrical Stimulation","FES Cycling","Photobiomodulation","Neuromodulation","Dual-Task Training","Upper Extremity Rehabilitation","Cognitive-Motor Performance","Stroke Rehabilitation","NOT_YET_RECRUITING","2026-09-02",{"date":211,"type":212},"2026-09-08","ACTUAL",{"date":214,"type":192},"2026-10-01",{"date":216,"type":192},"2028-10-01",{"name":5,"class":6}]