[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06465290":3,"trial-entities:NCT06465290":219,"trial-summary:NCT06465290":223},{"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":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":58,"secondary_outcomes":63,"sex":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":104,"locations":107,"central_contacts":123,"overall_officials":128,"references":132,"see_also_links":218},"NCT06465290","HP-00110703","Promoting Neuroplastic Changes of Patients With TBI","RECRUITING","2030-08-31","2026-07","2026-07-17","2026-07-16","University of Maryland, Baltimore","OTHER",true,"This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.","Early after TBI, patients often have significant sensorimotor impairment. There is heightened neural excitability, which may be used to facilitate recovery in the acute phase post stroke. However, there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy. The proposed randomized clinical trial using a wearable rehabilitation robot, muscle electromyography (EMG), and\u002For potentially brain electroencephalogram (EEG) signal seeks to provide early intensive sensorimotor training facilitated by real-time audiovisual and haptic feedback, intelligent stretching and sensory stimulation, active movement training through motivating movement games to promote neuroplasticity and reduce sensorimotor impairments. For acute TBI survivors who cannot generate any motor output yet, EMG or EEG may be used to detect the earliest re-emerging motor control signal and the robot can be used to provide demo and feedback of the intended movement.",[18],"Traumatic Brain Injury",[20,21,22],"Traumatic Brain Injury (TBI)","Paraplegia","Acute","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},100,"ESTIMATED",[31,37,41,45,50,54],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Motor relearning training with wearable ankle robot","Ankle motor control relearning training under real-time feedback",[36],"Study group - Intensive ankle\u002Fhand robot rehab",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Passive stretching with wearable ankle robot","Passive stretching under intelligent robotic control",[36],{"type":32,"name":42,"description":43,"armGroupLabels":44},"Gamed-based active movement training with wearable ankle robot","Active movement training through movement games with robotic assistance",[36],{"type":32,"name":46,"description":47,"armGroupLabels":48},"Passive movement with limited wearable ankle robot","Passive movement in the joint middle range of motion",[49],"Control group - Mild ankle\u002Fhand robot rehab",{"type":32,"name":51,"description":52,"armGroupLabels":53},"Active movement training with limited wearable ankle robot","Active movement training without robotic assistance",[49],{"type":32,"name":55,"description":56,"armGroupLabels":57},"Ankle\u002FWrist torque and motion measurement with limited wearable ankle\u002Fwrist robot","Ankle\u002FWrist torque and motion measurement with no real-time feedback",[49],[59],{"measure":60,"description":61,"timeFrame":62},"Fugl-Meyer Lower Extremity (FMLE)","The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function.","At the beginning and end of 3-week training, and 1 month after the treatment ends]",[64,68,71,74,77,80],{"measure":65,"description":66,"timeFrame":67},"Active range of motion (AROM)","AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle.","At the beginning and end of 3-week training, and 1 month after the treatment ends",{"measure":69,"description":70,"timeFrame":67},"Passive Range of Motion (PROM)","Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.",{"measure":72,"description":73,"timeFrame":67},"Strength of the ankle flexor-extensor muscle","Strength of the ankle flexor-extensor muscle will be measured in Newtons",{"measure":75,"description":76,"timeFrame":67},"Modified Ashworth Scale (MAS)","The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.",{"measure":78,"description":79,"timeFrame":67},"Berg Balance Scale","The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The Berg balance scale ranges from 0 to 56. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.",{"measure":81,"description":82,"timeFrame":67},"10-meter Walk Test","The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance at the beginning and end of 3-week training, and 1 month after the treatment ends. It can be employed to determine functional mobility and gait function.","ALL","30 Years","85 Years",false,{"inclusion":88,"exclusion":94,"raw_text":103},[89,90,91,92,93],"Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)","Hemiplegia or hemiparesis","0≤Manual Muscle Testing (MMT)\\\u003C=2","Age 30-85","Ankle impairments including stiff calf muscles and\u002For inadequate dorsiflexion",[95,96,97,98,99,100,101,102],"Medically not stable","Associated acute medical illness that interferes with ability to training and exercise","No impairment or very mild ankle impairment of ankle","Severe cardiovascular problems that interfere with ability to perform moderate movement exercises","Cognitive impairment or aphasia with inability to follow instructions","Severe pain in legs","Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)","Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee","Inclusion Criteria:\n\n* Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)\n* Hemiplegia or hemiparesis\n* 0≤Manual Muscle Testing (MMT)\\\u003C=2\n* Age 30-85\n* Ankle impairments including stiff calf muscles and\u002For inadequate dorsiflexion\n\nExclusion Criteria:\n\n* Medically not stable\n* Associated acute medical illness that interferes with ability to training and exercise\n* No impairment or very mild ankle impairment of ankle\n* Severe cardiovascular problems that interfere with ability to perform moderate movement exercises\n* Cognitive impairment or aphasia with inability to follow instructions\n* Severe pain in legs\n* Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)\n* Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee",[105,106],"ADULT","OLDER_ADULT",[108],{"facility":109,"status":7,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":120},"Li-Qun Zhang","Baltimore","Maryland","21201","United States",[115],{"name":116,"role":117,"phone":118,"email":119},"Li-Qun Zhang, PhD","CONTACT","4107062145","l-zhang@som.umaryland.edu",{"lat":121,"lon":122},39.29038,-76.61219,[124],{"name":125,"role":117,"phone":126,"email":127},"Soh-Hyun Hur","410 706-8625","SoHur@som.umaryland.edu",[129],{"name":109,"affiliation":130,"role":131},"University of Maryland","PRINCIPAL_INVESTIGATOR",[133,137,140,143,146,149,152,155,158,161,164,167,170,173,176,179,182,185,188,191,194,197,200,203,206,209,212,215],{"pmid":134,"type":135,"citation":136},"34665733","BACKGROUND","Zhang C, Huang MZ, Kehs GJ, Braun RG, Cole JW, Zhang LQ. Intensive In-Bed Sensorimotor Rehabilitation of Early Subacute Stroke Survivors With Severe Hemiplegia Using a Wearable Robot. IEEE Trans Neural Syst Rehabil Eng. 2021;29:2252-2259. doi: 10.1109\u002FTNSRE.2021.3121204. Epub 2021 Nov 4.",{"pmid":138,"type":135,"citation":139},"22466792","Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177\u002F1545968312440745. Epub 2012 Mar 30.",{"pmid":141,"type":135,"citation":142},"21571152","Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016\u002FS0140-6736(11)60325-5.",{"pmid":144,"type":135,"citation":145},"8734610","Nudo RJ, Milliken GW. Reorganization of movement representations in primary motor cortex following focal ischemic infarcts in adult squirrel monkeys. J Neurophysiol. 1996 May;75(5):2144-9. doi: 10.1152\u002Fjn.1996.75.5.2144.",{"pmid":147,"type":135,"citation":148},"27337720","Ren Y, Wu YN, Yang CY, Xu T, Harvey RL, Zhang LQ. Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2017 Jun;25(6):589-596. doi: 10.1109\u002FTNSRE.2016.2584003. Epub 2016 Jun 22.",{"pmid":150,"type":135,"citation":151},"12509602","Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542\u002Fpeds.111.1.e89.",{"pmid":153,"type":135,"citation":154},"16344031","Selles RW, Li X, Lin F, Chung SG, Roth EJ, Zhang LQ. Feedback-controlled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. Arch Phys Med Rehabil. 2005 Dec;86(12):2330-6. doi: 10.1016\u002Fj.apmr.2005.07.305.",{"pmid":156,"type":135,"citation":157},"24792141","Sukal-Moulton T, Clancy T, Zhang LQ, Gaebler-Spira D. Clinical application of a robotic ankle training program for cerebral palsy compared to the research laboratory application: does it translate to practice? Arch Phys Med Rehabil. 2014 Aug;95(8):1433-40. doi: 10.1016\u002Fj.apmr.2014.04.010. Epub 2014 May 2.",{"pmid":159,"type":135,"citation":160},"23648617","Waldman G, Yang CY, Ren Y, Liu L, Guo X, Harvey RL, Roth EJ, Zhang LQ. Effects of robot-guided passive stretching and active movement training of ankle and mobility impairments in stroke. NeuroRehabilitation. 2013;32(3):625-34. doi: 10.3233\u002FNRE-130885.",{"pmid":162,"type":135,"citation":163},"21343525","Wu YN, Hwang M, Ren Y, Gaebler-Spira D, Zhang LQ. Combined passive stretching and active movement rehabilitation of lower-limb impairments in children with cerebral palsy using a portable robot. Neurorehabil Neural Repair. 2011 May;25(4):378-85. doi: 10.1177\u002F1545968310388666. Epub 2011 Feb 22.",{"pmid":165,"type":135,"citation":166},"20132137","Wu YN, Ren Y, Goldsmith A, Gaebler D, Liu SQ, Zhang LQ. Characterization of spasticity in cerebral palsy: dependence of catch angle on velocity. Dev Med Child Neurol. 2010 Jun;52(6):563-9. doi: 10.1111\u002Fj.1469-8749.2009.03602.x. Epub 2010 Jan 28.",{"pmid":168,"type":135,"citation":169},"9535973","Xerri C, Merzenich MM, Peterson BE, Jenkins W. Plasticity of primary somatosensory cortex paralleling sensorimotor skill recovery from stroke in adult monkeys. J Neurophysiol. 1998 Apr;79(4):2119-48. doi: 10.1152\u002Fjn.1998.79.4.2119.",{"pmid":171,"type":135,"citation":172},"23063880","Yang CY, Guo X, Ren Y, Kang SH, Zhang LQ. Position-dependent, hyperexcitable patellar reflex dynamics in chronic stroke. Arch Phys Med Rehabil. 2013 Feb;94(2):391-400. doi: 10.1016\u002Fj.apmr.2012.09.029. Epub 2012 Oct 11.",{"pmid":174,"type":135,"citation":175},"23636726","Zhang LQ, Chung SG, Ren Y, Liu L, Roth EJ, Rymer WZ. Simultaneous characterizations of reflex and nonreflex dynamic and static changes in spastic hemiparesis. J Neurophysiol. 2013 Jul;110(2):418-30. doi: 10.1152\u002Fjn.00573.2012. Epub 2013 May 1.",{"pmid":177,"type":135,"citation":178},"11535659","Zhang LQ, Rymer WZ. Reflex and intrinsic changes induced by fatigue of human elbow extensor muscles. J Neurophysiol. 2001 Sep;86(3):1086-94. doi: 10.1152\u002Fjn.2001.86.3.1086.",{"pmid":180,"type":135,"citation":181},"10896002","Zhang LQ, Wang G, Nishida T, Xu D, Sliwa JA, Rymer WZ. Hyperactive tendon reflexes in spastic multiple sclerosis: measures and mechanisms of action. Arch Phys Med Rehabil. 2000 Jul;81(7):901-9. doi: 10.1053\u002Fapmr.2000.5582.",{"pmid":183,"type":135,"citation":184},"21596920","Zhao H, Wu YN, Hwang M, Ren Y, Gao F, Gaebler-Spira D, Zhang LQ. Changes of calf muscle-tendon biomechanical properties induced by passive-stretching and active-movement training in children with cerebral palsy. J Appl Physiol (1985). 2011 Aug;111(2):435-42. doi: 10.1152\u002Fjapplphysiol.01361.2010. Epub 2011 May 19.",{"pmid":186,"type":135,"citation":187},"21964750","Albert SJ, Kesselring J. Neurorehabilitation of stroke. J Neurol. 2012 May;259(5):817-32. doi: 10.1007\u002Fs00415-011-6247-y. Epub 2011 Oct 1.",{"pmid":189,"type":135,"citation":190},"17225037","Bernhardt J, Chan J, Nicola I, Collier JM. Little therapy, little physical activity: rehabilitation within the first 14 days of organized stroke unit care. J Rehabil Med. 2007 Jan;39(1):43-8. doi: 10.2340\u002F16501977-0013.",{"pmid":192,"type":135,"citation":193},"14988574","Bernhardt J, Dewey H, Thrift A, Donnan G. Inactive and alone: physical activity within the first 14 days of acute stroke unit care. Stroke. 2004 Apr;35(4):1005-9. doi: 10.1161\u002F01.STR.0000120727.40792.40. Epub 2004 Feb 26.",{"pmid":195,"type":135,"citation":196},"18374001","Chung SG, van Rey E, Bai Z, Rymer WZ, Roth EJ, Zhang LQ. Separate quantification of reflex and nonreflex components of spastic hypertonia in chronic hemiparesis. Arch Phys Med Rehabil. 2008 Apr;89(4):700-10. doi: 10.1016\u002Fj.apmr.2007.09.051.",{"pmid":198,"type":135,"citation":199},"15468024","Chung SG, Van Rey E, Bai Z, Roth EJ, Zhang LQ. Biomechanic changes in passive properties of hemiplegic ankles with spastic hypertonia. Arch Phys Med Rehabil. 2004 Oct;85(10):1638-46. doi: 10.1016\u002Fj.apmr.2003.11.041.",{"pmid":201,"type":135,"citation":202},"26903143","Chen K, Wu YN, Ren Y, Liu L, Gaebler-Spira D, Tankard K, Lee J, Song W, Wang M, Zhang LQ. Home-Based Versus Laboratory-Based Robotic Ankle Training for Children With Cerebral Palsy: A Pilot Randomized Comparative Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1237-43. doi: 10.1016\u002Fj.apmr.2016.01.029. Epub 2016 Feb 20.",{"pmid":204,"type":135,"citation":205},"20101040","Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society; Delgado MR, Hirtz D, Aisen M, Ashwal S, Fehlings DL, McLaughlin J, Morrison LA, Shrader MW, Tilton A, Vargus-Adams J. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2010 Jan 26;74(4):336-43. doi: 10.1212\u002FWNL.0b013e3181cbcd2f.",{"pmid":207,"type":135,"citation":208},"19406302","Gao F, Grant TH, Roth EJ, Zhang LQ. Changes in passive mechanical properties of the gastrocnemius muscle at the muscle fascicle and joint levels in stroke survivors. Arch Phys Med Rehabil. 2009 May;90(5):819-26. doi: 10.1016\u002Fj.apmr.2008.11.004.",{"pmid":210,"type":135,"citation":211},"21211873","Gao F, Ren Y, Roth EJ, Harvey R, Zhang LQ. Effects of repeated ankle stretching on calf muscle-tendon and ankle biomechanical properties in stroke survivors. Clin Biomech (Bristol). 2011 Jun;26(5):516-22. doi: 10.1016\u002Fj.clinbiomech.2010.12.003. Epub 2011 Jan 6.",{"pmid":213,"type":135,"citation":214},"18948443","Gao F, Zhang LQ. Altered contractile properties of the gastrocnemius muscle poststroke. J Appl Physiol (1985). 2008 Dec;105(6):1802-8. doi: 10.1152\u002Fjapplphysiol.90930.2008. Epub 2008 Oct 23.",{"pmid":216,"type":135,"citation":217},"3588947","Jenkins WM, Merzenich MM. Reorganization of neocortical representations after brain injury: a neurophysiological model of the bases of recovery from stroke. Prog Brain Res. 1987;71:249-66. doi: 10.1016\u002Fs0079-6123(08)61829-4. No abstract available.",[],{"nct_id":4,"conditions":220,"biomarkers":222},[221],"Stroke",[],{"nct_id":4,"found":14,"summary":224,"prompt_version":234},{"design":225,"status":226,"heading":227,"summary":228,"follow_up":229,"word_count":230,"commitments":231,"compensation":232,"drugs_mentioned":233},"This interventional study plans to enroll 100 participants. It is testing different rehabilitation methods using a wearable ankle robot.","completed","Wearable Ankle Robot for Traumatic Brain Injury Rehabilitation","This study is testing different ways to use a wearable ankle robot to help people recover from a traumatic brain injury (TBI). The robot can provide motor relearning training, passive stretching, game-based active movement training, passive movement, and active movement training. This research aims to improve movement and reduce problems like stiff calf muscles or difficulty lifting the foot (inadequate dorsiflexion). You might be able to join if you are 30-85 years old, have had a first-time stroke within the last month, and have weakness or paralysis on one side of your body (hemiplegia or hemiparesis). The study will measure success by looking at changes in your lower body movement using the Fugl-Meyer Lower Extremity (FMLE) score, measured at the beginning, end of a 3-week training, and one month later. The current status of this study is unclear.","Participants will be followed for one month after the treatment ends.",138,"Participants will undergo a 3-week training period. Assessments will be done at the beginning and end of this training, and one month after it concludes.","Not stated in the trial record.",[],"v2"]