[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07042152":3,"trial-entities:NCT07042152":147,"trial-summary:NCT07042152":151},{"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":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":49,"secondary_outcomes":54,"sex":87,"minimum_age":88,"maximum_age":89,"healthy_volunteers":15,"eligibility_criteria":90,"std_ages":111,"locations":114,"central_contacts":133,"overall_officials":139,"references":141,"see_also_links":146},"NCT07042152","2621","Wearable Device and Behavioral Support for Enhancing Arm Use After Stroke","Sensor Enhanced Activity Motivation After Stroke","RECRUITING","2026-01-29","2025-08","2025-08-19","2025-08-20","University of California, Irvine","OTHER",false,"The goal of this study is to determine the effectiveness of behavioral support and feedback from a wearable device that senses arm movement in improving upper extremity function in a pilot, randomized controlled trial with chronic stroke patients","In this randomized controlled trial, the investigators will evaluate two telerehabilitation strategies for increasing arm use at home: a smartwatch app and a psychological intervention. The psychological intervention aims to address ambivalence and enhance motivation, while the smartwatch provides feedback on arm movement variability. The investigators hypothesize that combining the psychological intervention with smartwatch feedback will lead to greater improvements in arm use and upper extremity recovery",[19],"Chronic Stroke Patients",[21,22,23,24,25],"Sensor","SmartWatch","Stroke Recovery","Stroke Rehabilitation","Motivational Interviewing","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},32,"ESTIMATED",[34,39,44],{"type":14,"name":35,"description":36,"armGroupLabels":37},"Smartwatch App for Movement Variability","This app measures movement variability in the upper extremity as described in our previous study (doi:10.3390\u002Fs24165266).",[38],"Movement Variability",{"type":14,"name":40,"description":41,"armGroupLabels":42},"Smartwatch App for Active Time","The other software we are using measures total active time of the upper extremity.",[43],"Active Time (Control)",{"type":45,"name":46,"description":47,"armGroupLabels":48},"BEHAVIORAL","Motivational Interviewing (Within Subjects)","Motivational Interviewing is an established therapeutic technique designed to increase patient adherence to therapy by addressing ambivalence. The motivational Interviewing sessions will include a variety of techniques such as: Open ended questions, Active Listening, Affirmation, Summarization, Questions focused on change talk, and Providing Information.",[43,38],[50],{"measure":51,"description":52,"timeFrame":53},"Variability Measurement","The amount of variability for the impaired upper extremity will be quantified by the variety of movements performed.","From enrollment to the end of treatment and follow up measurement (9 weeks)",[55,58,62,66,69,72,75,78,81,84],{"measure":56,"description":57,"timeFrame":53},"Active Time","This outcome measures the active time of the impaired upper extremity in minutes and hours.",{"measure":59,"description":60,"timeFrame":61},"Fugl-Meyer Arm Motor Assessment","The Fugl-Meyer Arm Motor Assessment measures motor impairment, movement coordination, reflexes, and functional ability of the upper limb in stroke patients, providing a quantitative evaluation of motor recovery based on a standardized scoring system.","Initial Visit, First follow up, Second follow up",{"measure":63,"description":64,"timeFrame":65},"Box and Blocks Test","The Box and Blocks Test (BBT) measures manual dexterity, unilateral gross motor function, and upper limb coordination in stroke patients by assessing the number of blocks transferred within a set time, providing an objective indicator of motor recovery and functional hand use.","Initial Visit, First follow up, second follow up",{"measure":67,"description":68,"timeFrame":61},"Nine Hole Peg Test","The 9-Hole Peg Test (9HPT) measures fine motor coordination, dexterity, and finger-hand function by assessing the speed at which a participant can place and remove pegs from a board.",{"measure":70,"description":71,"timeFrame":61},"Motor Activity Log (MAL)","The Motor Activity Log (MAL) measures the amount and quality of spontaneous arm use in daily activities in stroke patients with hemiparesis, using patient-reported ratings on a structured questionnaire to assess real-world upper limb function.",{"measure":73,"description":74,"timeFrame":61},"Open Point","Open Point measures proprioception in patients with impaired upper extremity function due to stroke.\n\nCornella-Barba, G., Farrens, A. J., Johnson, C. A., Garcia-Fernandez, L., Chan, V., \\& Reinkensmeyer, D. J. (2024). Using a Webcam to Assess Upper Extremity Proprioception: Experimental Validation and Application to Persons Post Stroke. Sensors (Basel, Switzerland), 24(23), 7434. https:\u002F\u002Fdoi.org\u002F10.3390\u002Fs24237434",{"measure":76,"description":77,"timeFrame":61},"NIH Stroke Scale","The NIH Stroke Scale (NIHSS) measures stroke severity by assessing neurological function, including consciousness, motor and sensory abilities, language, vision, and inattention to quantify impairment.",{"measure":79,"description":80,"timeFrame":61},"Fatigue Severity Scale (FSS)","The Fatigue Severity Scale (FSS) measures the impact of fatigue on daily functioning and quality of life, assessing both the severity and the effect of fatigue on physical and cognitive activities through a self-reported questionnaire.",{"measure":82,"description":83,"timeFrame":61},"Fugl-Meyer Sensory Assessment: Touch and Proprioception","The Fugl-Meyer Sensory Assessment evaluates sensory function in stroke patients by assessing light touch sensitivity and joint position sense (proprioception) in the affected limbs.",{"measure":85,"description":86,"timeFrame":61},"Kinect: Sensor-based Upper Extremity Reachable Workspace Evaluation","The Kinect workspace measures the three-dimensional reachable space of the upper limb in hemiplegic stroke patients by tracking movement using a Kinect sensor, providing an objective assessment of functional reaching ability.\n\nLee, Y. M., Lee, S., Uhm, K. E., Kurillo, G., Han, J. J., \\& Lee, J. (2020). Upper Limb Three-Dimensional Reachable Workspace Analysis Using the Kinect Sensor in Hemiplegic Stroke Patients: A Cross-Sectional Observational Study. American journal of physical medicine \\& rehabilitation, 99(5), 397-403. https:\u002F\u002Fdoi.org\u002F10.1097\u002FPHM.0000000000001350","ALL","18 Years","84 Years",{"inclusion":91,"exclusion":96,"raw_text":110},[92,93,94,95],"18 to 85 years of age","Experienced a single or multiple, ischemic or hemorrhagic stroke, with unilateral weakness, over six months previously","An ability to score at least 3 blocks on the Box and Block Test. BBT score of the affected arm is at least 5% worse than that present with the unaffected arm.","Absence of major depression, as defined by DSM V criteria or a score on the Geriatric Depression Scale \\\u003C 10.",[97,98,99,100,101,102,103,104,105,106,107,108,109],"Any substantial decrease in alertness, language reception, or attention","Single or multiple, ischemic or hemorrhagic stroke less than 6 months ago","Severe muscle tone at the upper extremity (score ≥ 3 on the Modified Ashworth Spasticity scale)","Pregnant or lactating","Advanced liver, kidney, cardiac, or pulmonary disease","Coexistent major neurological disease","Coexistent major psychiatric disease","Plans to alter any current participation in other rehabilitation therapy in the time period of the study","A terminal medical diagnosis consistent with survival \\\u003C 1 year","A history of significant alcohol or drug abuse in the prior 3 years","Current enrollment in another study related to stroke or stroke recovery","Any other medical contraindication to participation in the study, as evaluated by our team physician.","Visual Analog of Pain Scale Score of 7 or greater","Inclusion Criteria:\n\n* 18 to 85 years of age\n* Experienced a single or multiple, ischemic or hemorrhagic stroke, with unilateral weakness, over six months previously\n* An ability to score at least 3 blocks on the Box and Block Test. BBT score of the affected arm is at least 5% worse than that present with the unaffected arm.\n* Absence of major depression, as defined by DSM V criteria or a score on the Geriatric Depression Scale \\\u003C 10.\n\nExclusion Criteria:\n\n* Any substantial decrease in alertness, language reception, or attention\n* Single or multiple, ischemic or hemorrhagic stroke less than 6 months ago\n* Severe muscle tone at the upper extremity (score ≥ 3 on the Modified Ashworth Spasticity scale)\n* Pregnant or lactating\n* Advanced liver, kidney, cardiac, or pulmonary disease\n* Coexistent major neurological disease\n* Coexistent major psychiatric disease\n* Plans to alter any current participation in other rehabilitation therapy in the time period of the study\n* A terminal medical diagnosis consistent with survival \\\u003C 1 year\n* A history of significant alcohol or drug abuse in the prior 3 years\n* Current enrollment in another study related to stroke or stroke recovery\n* Any other medical contraindication to participation in the study, as evaluated by our team physician.\n* Visual Analog of Pain Scale Score of 7 or greater",[112,113],"ADULT","OLDER_ADULT",[115],{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":120,"contacts":121,"geoPoint":130},"University of California Irvine","Irvine","California","92697","United States",[122,127],{"name":123,"role":124,"phone":125,"email":126},"Vicky Chan, DPT","CONTACT","949-824-8423","vchan2@uci.edu",{"name":128,"role":129},"David Reinkensmeyer, PhD","PRINCIPAL_INVESTIGATOR",{"lat":131,"lon":132},33.66946,-117.82311,[134,136],{"name":123,"role":124,"phone":135,"email":126},"9498248423",{"name":137,"role":124,"email":138},"Natanya Gunn, Medical Student","natanyag@hs.uci.edu",[140],{"name":128,"affiliation":13,"role":129},[142],{"pmid":143,"type":144,"citation":145},"36146287","BACKGROUND","Schwerz de Lucena D, Rowe JB, Okita S, Chan V, Cramer SC, Reinkensmeyer DJ. Providing Real-Time Wearable Feedback to Increase Hand Use after Stroke: A Randomized, Controlled Trial. Sensors (Basel). 2022 Sep 14;22(18):6938. doi: 10.3390\u002Fs22186938.",[],{"nct_id":4,"conditions":148,"biomarkers":150},[149],"Stroke",[],{"nct_id":4,"found":152,"summary":153,"prompt_version":162},true,{"design":154,"status":155,"heading":6,"summary":156,"follow_up":157,"word_count":158,"commitments":159,"compensation":160,"drugs_mentioned":161},"This is a randomized controlled trial, meaning participants will be assigned by chance to different groups. It aims to enroll 32 participants.","completed","This study is looking at how well a smartwatch app and behavioral support can help people who have had a stroke improve their arm use. The smartwatch apps measure how much you move your arm and how varied your movements are. The behavioral support uses \"Motivational Interviewing,\" a technique to help you stick with therapy. To join, you need to be between 18 and 85 years old, have experienced a stroke more than six months ago, and have some weakness in one arm. The main goal is to see if these interventions improve how much you use your arm. The study is currently unclear about its recruitment status and plans to enroll 32 participants.","Your arm movement variability will be measured from when you join until the end of treatment and for a follow-up period of 9 weeks.",114,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]