Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:48 AM
Study NCT ID:
NCT07440459
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2025-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Neuroplastic Mechanisms With Modeling-based Optimization of a Novel Robot-asisted Walking Rehabilitation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manual evaluation of motor function in spinal cord injury using the Lower Extremity Motor Score (LEMS) of the American Spinal Injury Association (ASIA)', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'Assessment performed according to the International Standards for the Classification of Spinal Cord Injury, following the motor examination guidelines of the American Spinal Injury Association (ASIA). The test qualitatively assesses motor function using a 6-point scale ranging from 0 to 5. A score of 0 indicates total paralysis. A score of 1 indicates palpable or visible contraction. A score of 2 indicates active movement with gravity eliminated. A score of 3 indicates active movement against gravity. A score of 4 indicates active movement against gravity with moderate resistance. A score of 5 indicates normal motor function. The test evaluates five key muscles in both lower limbs: hip flexors (Iliopsoas), knee extensors (Quadriceps), ankle dorsiflexors (Tibialis Anterior), long toe extensors (Extensor Hallucis Longus), and ankle plantarflexors (Gastrocnemius and Soleus).'}], 'secondaryOutcomes': [{'measure': 'Assessment of Corticospinal pathway conduction using Motor Evoked Potentials (MEPs) with Transcranial Magnetic Stimulation (TMS)', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'Parameters of corticospinal pathway conduction are assessed. Transcranial Magnetic Stimulation (TMS) is applied to the primary motor cortex to elicit neural responses recorded from the rectus femoris, tibialis anterior and abductor hallucis muscles using surface electromyography (EMG). Participants receive five pulses at each stimulation intensity (40%, 50%, 60%, 70%, 80%), as well as three 3 additional pulses at 100% of the maximum device output. Motor evoked potentials recorded by EMG are analyzed for presence or absence, amplitude, and latency.'}, {'measure': 'Assessment of Proximal motor conduction with M and F waves recorded in the abductor hallucis muscle.', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'The stimulator is placed on the posterior aspect of the medial malleolus over the posterior tibial nerve, and muscle responses are recorded from the abductor hallucis. The stimlation intensity at wich the M-wave amplitude no longer increases is determined, and three stimuli are recorded. For F-wave assessment, the stimulation intensity is increased to 130% of the M-wave intensity, and twenty stimuli are recorded. The presence or absence of the F wave is used to assess proximal motor conduction.'}, {'measure': 'Spasticity as assessed by the Modified Ashworth Scale (MAS)', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'The Modified Ashworth Scale (MAS) measures spasticity in patients with neurological disorders of the central nervous system. Spasticity is defined as an increase in muscle tone that is dependent on the speed of movement. The MAS is a modified version of Ashworth Scale and provides a spasticity score ranging from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).'}, {'measure': 'Assessment of walking speed using the 10-Meter Walk Test (10MWT)', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'The 10-Meter Walk Test assesses walking speed in patients with spinal cord injury along a 10-meter corridor. Participants may use assistive devices as needed. The first 2 meters are used to reach a steady walking speed, and the final 2 meters are used for slowing down; time is recorded over the central 6 meters.'}, {'measure': 'Walking ability, fall risk, mobility, and balance as assessed by the Timed Up and Go (TUG) test.', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': "The test starts with the participant seated in a chair. It measures the time required to stand up from the chair, walk to and around a cone located 3 meters away, and sit back down in the same chair. Timing starts at the therapist's signal and finishes when the participant's buttocks touch the chair. Participants may use assistive devices if needed; however, they may only use them for walking and not for standing up."}, {'measure': 'Walking ability as assessed by the Walking Index for Spinal Cord Injury II (WISCI-II)', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'The Walking Index for Spinal Cord Injury II (WISCI-II) measures the need for assistance and devices for walking after a spinal cord injury. The scale consists of 21 items scored from 0 to 20, where 0 indicates inability to walk and 20 indicates the ability to walk 10 meters without assistance, orthoses, or walking devices. Walking devices include parallel bars, walkers, crutches, and canes. Orthoses include long leg braces, short leg braces, and knee braces with the knee locked or unlocked. Assistance refers to the need for support from one or two persons. The assessment is based on the ability to walk a distance of 10 meters.'}, {'measure': 'Functional assessment of specific areas in patients with spinal cord injury using the Spinal Cord Independence Measure III (SCIM-III) score', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'SCIM III is functional assessment tool designed for patients with spinal cord injury. It includes three functional domains: self-care (subscore 0-20), respiration and sphincter management (subscore 0-40) and mobility (subscore 0-40). The total score ranges from 0 to 100. Self-care area consist of six items, including feeding, bathing, dressing, and grooming. The respiration and sphincter management domain include four items: respiration, bladder management, bowel management and the use of the toilet. The mobility domain include nine items, divided into tasks performed in the room and toilet, and tasks performed indoors and outdoors. Administration of the assessment takes up to 60 minutes, including observation and patient interview.'}, {'measure': 'Muscle strength assessed by maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'Eight muscles of each lower limb (gluteus medius, rectus femoris, vastus lateralis, biceps femoris, semitendinosus, tibialis anterior, soleus, and medial gastrocnemius) will be monitored using electromyography (EMG). Isometric force exerted against the hand-held dynamometer will be measured during knee flexion and extension, hip abduction, and ankle plantarflexion and dorsiflexion. Maximum contraction will be maintained for 3-5 seconds, and the peak force achieved during this period will be recorded in newtons. Three repetitions of each movement will be performed, and the mean value will be calculated. Participants will be positioned sitting for knee flexion and extension and supine for hip abduction and ankle plantarflexion and dorsiflexion. The distance between the joint involved and the point at which resistance is exerted will be recorded.'}, {'measure': 'Assessing muscle activation during maximum voluntary isometric contraction (MVIC) using surface electromyography (EMG).', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'This procedure will be used to normalize EMG signals recorded during three-dimensional gait analysis. Activation of eight muscles of each lower limb (gluteus medius, rectus femoris, vastus lateralis, biceps femoris, semitendinosus, tibialis anterior, soleus, and medial gastrocnemius) will be recorded using surface EMG. Isometric force exerted against the hand-held dynamometer and the muscle activation derived from the contraction will be measured during knee flexion and extension, hip abduction, and ankle plantarflexion and dorsiflexion. Maximum contraction will be maintained for 3-5 seconds. Three repetitions of each movement will be performed, and the mean value will be calculated. Participants will be positioned sitting for knee flexion and extension and supine for hip abduction and ankle plantarflexion and dorsiflexion. The distance between the joint involved and the point at which resistance is exerted will be recorded.'}, {'measure': 'Pain intensity assessed using the Visual Analogue Scale (VAS) after Lokomat sessions, the 10-meter walk test (10MWT), and the Timed Up and Go (TUG) test.', 'timeFrame': 'After each Lokomat session (5 days/week for 8 weeks) and after the 10-meter walk test (10MWT) and Timed Up and Go (TUG) test at Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8), and at follow-up 4 weeks after the intervention.', 'description': 'Participants will mark their perceived pain intensity on a 10-centimeter line, anchored at 0 (no pain) and 10 (worst imaginable pain). The distance from the zero point will be measured in centimeters to determine the pain score.'}, {'measure': 'Perceived effort, exertion, breathlessness, and fatigue assessed using the modified Borg scale after Lokomat sessions, the 10-meter walk test (10MWT), and the Timed Up and Go (TUG) test.', 'timeFrame': 'After each Lokomat session (5 days/week for 8 weeks) and after the 10-meter walk test (10MWT) and Timed Up and Go (TUG) test at Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8), and at follow-up 4 weeks after the intervention.', 'description': 'The modified Borg scale is an 11-point scale ranging from 0 (nothing at all) to 10 (very, very hard), measuring patient-perceived fatigue during physical activity or exercise.'}, {'measure': 'Biomechanical gait parameters, including kinematics, assessed using three-dimensional gait analysis (3DGA) with a motion capture system during walking on a 10-meter corridor.', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'Participants will be instrumented with passive markers according to the Vicon Plug-in Gait model, with additional markers on the foot. They will walk barefoot in a 10-meter corridor, unless an orthosis requires wearing shoes, while the system records each trial. Participants will also perform a sit-to-stand movement. Assistive devices may be used as needed. The resulting recordings will be processed using Vicon software, and the data will be prepared for subsequent analysis.'}, {'measure': 'Kinetic gait parameters, including ground reaction forces, assessed using a motion capture system and force platforms during walking on a 10-meter corridor.', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'Participants will be instrumented with passive markers according to the Vicon Plug-in Gait model, with additional markers on the foot. They will walk in a 10-meter corridor with two force platforms embedded in the middle, which will record ground reaction forces, while the Vicon motion capture system records each trial. Participants will walk barefoot unless an orthosis requires wearing shoes. They will also perform a sit-to-stand movement. Assistive devices may be used as needed. The resulting recordings will be processed using Vicon software, and the data will be prepared for subsequent analysis.'}, {'measure': 'Lower limb muscle activity during three-dimensional gait analysis as assessed by surface elecgromyography', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, post-intervention at Week 8, and follow-up 4 weeks after completion of the intervention (Week 12).', 'description': 'Participants are instrumented with passive reflective markers according to the Vicon Plug-in Gait model, with additional markers placed on the foot. Participants walk along a 10-meter corridor while the Vicon motion capture system records each trial. Participants walk barefoot unless an orthosis requiring shoes is used. Surface electromyography electrodes are placed on eight muscles of each lower limb (gluteus medius, rectus femoris, vastus lateralis, biceps femoris, semitendinosus, tibialis anterior, soleus, and medial gastrocnemius) following SENIAM recommendations. A sit-to-stand movement is also performed. Participants may use assistive devices as needed.'}, {'measure': 'Maximum voluntary isometric torque (MVIT) as assessed by the Lokomat L-FORCE tool.', 'timeFrame': 'Once weekly, after a Lokomat session, during the 2-month intervention.', 'description': 'The Lokomat L-FORCE tool assesses maximum voluntary isometric torque (MVIT) during hip and knee flexion and extension. Torque is measured in Newton-meters (Nm). During testing, the exoskeleton is maintained in a fixed position, and participants are instructed to perform maximal voluntary isometric contractions against the device resistance. The assessment sequence includes right hip flexion, right hip extension, left hip flexion, left hip extension, right knee flexion, right knee extension, left knee flexion, and left knee extension.'}, {'measure': 'Joint stiffness at three angular velocities as assessed by the Lokomat L-STIFF tool.', 'timeFrame': 'Once weekly, after a Lokomat session, during the 2-month intervention.', 'description': 'The Lokomat L-STIFF tool assesses joint stiffness during passive hip and knee flexion and extension at three angular velocities (30°/s, 60°/s, and 120°/s). Stiffness is measured in Newton-meters per degree (Nm/°). During testing, participants remain relaxed while the Lokomat passively moves each joint individually at the specified velocities.'}, {'measure': 'User experience as assessed by an adapted version of the Usability Metric for User Experience (UMUX) questionnaire.', 'timeFrame': 'Baseline (Week 0), during the 2-month Lokomat intervention at Week 4, and post-intervention at Week 8.', 'description': 'The Usability Metric for User Experience (UMUX) is a self-administered questionnaire designed to assess perceived usability and user satisfaction with the intervention. The adapted version used in this study consists of 10 items. Each item is rated on a 7-point Likert scale ranging from 1 ("completely disagree") to 7 ("completely agree"), where 4 represents "neither agree nor disagree."'}, {'measure': 'Walking speed during gait training with the Lokomat system (km/h).', 'timeFrame': 'During each Lokomat session, conducted 5 times per week (Monday through Friday) for 4 consecutive weeks.', 'description': 'The Lokomat system will automatically record gait training parameters modified by the physiotherapist during each session. Walking speed will be documented in kilometers per hour (km/h). The programmable speed range is from 1.0 to 3.2 km/h.'}, {'measure': 'Body Weight Support (BWS) during gait training with the Lokomat system (kg).', 'timeFrame': 'During each Lokomat session, conducted 5 times per week (Monday through Friday) for 4 consecutive weeks.', 'description': "The Lokomat system will automatically record gait training parameters modified by the physiotherapist during each session. Body Weight Support (BWS) will be documented in kilograms (kg). The system allows adjustable unloading of the participant's body weight, with a programmable support range from 0 to 75 kg."}, {'measure': 'Guidance Force recorded by the Lokomat system during gait training (%)', 'timeFrame': 'During each Lokomat session, conducted 5 times per week (Monday through Friday) for 4 consecutive weeks.', 'description': "The Lokomat system will automatically record training parameters modified by the physiotherapist during each session, including Guidance Force expressed as a percentage (%), with a programmable range from 0% to 100%. This parameter reflects the degree of movement guidance provided by the exoskeleton. A value of 100% represents complete control of the exoskeleton's movements. Values below 80% indicate reduced robotic assistance and greater freedom of movement and active participation by the participant, whereas values below 20% correspond to minimal robotic guidance, and may be considered free movement."}, {'measure': 'Range of motion recorded by the Lokomat system for hips and knees (degrees)', 'timeFrame': 'During each Lokomat session, conducted 5 times per week (Monday through Friday) for 4 consecutive weeks.', 'description': 'The Lokomat system will automatically record training parameters modified by the physiotherapist during each session, including the range of motion (ROM) of the hips and knees of the exoskeleton.\n\n* Hip ROM ranges from 0° to 64°, with an adjustable variation of ±5° to adapt the movement to the participant. This parameter modifies flexion (negative values) and extension (positive values).\n* Knee ROM ranges from 0° to 85°, with an adjustable variation of 0° to 8°, applied to flexion.\n\nThe system can assess the desired movement (predetermined by the programmed parameters) and the actual movement performed by the participant. All measurements are recorded in degrees.'}, {'measure': 'Duration of gait training sessions recorded by the Lokomat system (minutes and seconds)', 'timeFrame': 'During each Lokomat session, conducted 5 times per week (Monday through Friday) for 4 consecutive weeks.', 'description': 'The Lokomat system will automatically record training parameters modified by the physiotherapist during each session, including session duration. Each session is planned to last 30 minutes; however, actual session duration may vary due to technical issues or other factors. Duration is recorded in minutes and seconds.'}, {'measure': 'Distance covered during gait training sessions recorded by the Lokomat system (meters)', 'timeFrame': 'During each Lokomat session, conducted 5 times per week (Monday through Friday) for 4 consecutive weeks.', 'description': 'The Lokomat system will automatically record training parameters modified by the physiotherapist during each session, including the distance covered. Distance is measured in meters and depends on the duration of the session and the programmed walking speed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal Cord Injury', 'walking rehabilitation', 'Lokomat', 'Gait analysis'], 'conditions': ['Spinal Cord Injuries (SCI)', 'Spinal Cord Injury', 'Neurorehabilitation', 'Robot Assisted Gait Training']}, 'referencesModule': {'references': [{'pmid': '33243615', 'type': 'BACKGROUND', 'citation': 'Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.'}, {'pmid': '31368379', 'type': 'BACKGROUND', 'citation': 'Cherni Y, Ballaz L, Girardin-Vignola G, Begon M. Intra- and inter-tester reliability of spasticity assessment in standing position in children and adolescents with cerebral palsy using a paediatric exoskeleton. Disabil Rehabil. 2021 Apr;43(7):1001-1007. doi: 10.1080/09638288.2019.1646814. Epub 2019 Aug 1.'}, {'pmid': '30587422', 'type': 'BACKGROUND', 'citation': 'Cherni Y, Girardin-Vignola G, Ballaz L, Begon M. Reliability of maximum isometric hip and knee torque measurements in children with cerebral palsy using a paediatric exoskeleton - Lokomat. Neurophysiol Clin. 2019 Sep;49(4):335-342. doi: 10.1016/j.neucli.2018.12.001. Epub 2018 Dec 23.'}, {'pmid': '25510190', 'type': 'BACKGROUND', 'citation': 'Aguilar-Rodriguez M, Pena-Paches L, Grao-Castellote C, Torralba-Collados F, Hervas-Marin D, Giner-Pascual M. Adaptation and validation of the Spanish self-report version of the Spinal Cord Independence Measure (SCIM III). Spinal Cord. 2015 Jun;53(6):451-4. doi: 10.1038/sc.2014.225. Epub 2014 Dec 16.'}, {'pmid': '23459122', 'type': 'BACKGROUND', 'citation': 'Ditunno JF Jr, Ditunno PL, Scivoletto G, Patrick M, Dijkers M, Barbeau H, Burns AS, Marino RJ, Schmidt-Read M. The Walking Index for Spinal Cord Injury (WISCI/WISCI II): nature, metric properties, use and misuse. Spinal Cord. 2013 May;51(5):346-55. doi: 10.1038/sc.2013.9. Epub 2013 Mar 5.'}, {'pmid': '21221120', 'type': 'BACKGROUND', 'citation': 'Scivoletto G, Tamburella F, Laurenza L, Foti C, Ditunno JF, Molinari M. Validity and reliability of the 10-m walk test and the 6-min walk test in spinal cord injury patients. Spinal Cord. 2011 Jun;49(6):736-40. doi: 10.1038/sc.2010.180. Epub 2011 Jan 11.'}, {'pmid': '21102574', 'type': 'BACKGROUND', 'citation': 'Shin JC, Yoo JH, Jung TH, Goo HR. Comparison of lower extremity motor score parameters for patients with motor incomplete spinal cord injury using gait parameters. Spinal Cord. 2011 Apr;49(4):529-33. doi: 10.1038/sc.2010.158. Epub 2010 Nov 23.'}, {'pmid': '3809245', 'type': 'BACKGROUND', 'citation': 'Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.'}, {'pmid': '22349304', 'type': 'BACKGROUND', 'citation': 'Groppa S, Oliviero A, Eisen A, Quartarone A, Cohen LG, Mall V, Kaelin-Lang A, Mima T, Rossi S, Thickbroom GW, Rossini PM, Ziemann U, Valls-Sole J, Siebner HR. A practical guide to diagnostic transcranial magnetic stimulation: report of an IFCN committee. Clin Neurophysiol. 2012 May;123(5):858-82. doi: 10.1016/j.clinph.2012.01.010. Epub 2012 Feb 19.'}, {'pmid': '26509', 'type': 'BACKGROUND', 'citation': 'Campbell G, Duxson MJ. The sympathetic innervation of lung muscle in the toad Bufo marinus: a revision and an explanation. Comp Biochem Physiol C Comp Pharmacol. 1978;60(1):65-73. doi: 10.1016/0306-4492(78)90029-1. No abstract available.'}, {'pmid': '26509265', 'type': 'BACKGROUND', 'citation': 'Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015.'}, {'pmid': '28330471', 'type': 'BACKGROUND', 'citation': 'Nam KY, Kim HJ, Kwon BS, Park JW, Lee HJ, Yoo A. Robot-assisted gait training (Lokomat) improves walking function and activity in people with spinal cord injury: a systematic review. J Neuroeng Rehabil. 2017 Mar 23;14(1):24. doi: 10.1186/s12984-017-0232-3.'}, {'pmid': '30489255', 'type': 'BACKGROUND', 'citation': 'Ruddy K, Balsters J, Mantini D, Liu Q, Kassraian-Fard P, Enz N, Mihelj E, Subhash Chander B, Soekadar SR, Wenderoth N. Neural activity related to volitional regulation of cortical excitability. Elife. 2018 Nov 29;7:e40843. doi: 10.7554/eLife.40843.'}, {'pmid': '27130577', 'type': 'BACKGROUND', 'citation': 'Reinkensmeyer DJ, Burdet E, Casadio M, Krakauer JW, Kwakkel G, Lang CE, Swinnen SP, Ward NS, Schweighofer N. Computational neurorehabilitation: modeling plasticity and learning to predict recovery. J Neuroeng Rehabil. 2016 Apr 30;13(1):42. doi: 10.1186/s12984-016-0148-3.'}, {'pmid': '19243614', 'type': 'BACKGROUND', 'citation': 'Huang VS, Krakauer JW. Robotic neurorehabilitation: a computational motor learning perspective. J Neuroeng Rehabil. 2009 Feb 25;6:5. doi: 10.1186/1743-0003-6-5.'}, {'pmid': '29866106', 'type': 'BACKGROUND', 'citation': 'Gassert R, Dietz V. Rehabilitation robots for the treatment of sensorimotor deficits: a neurophysiological perspective. J Neuroeng Rehabil. 2018 Jun 5;15(1):46. doi: 10.1186/s12984-018-0383-x.'}, {'pmid': '34757801', 'type': 'BACKGROUND', 'citation': "Dupont PE, Nelson BJ, Goldfarb M, Hannaford B, Menciassi A, O'Malley MK, Simaan N, Valdastri P, Yang GZ. A decade retrospective of medical robotics research from 2010 to 2020. Sci Robot. 2021 Nov 10;6(60):eabi8017. doi: 10.1126/scirobotics.abi8017. Epub 2021 Nov 10."}], 'seeAlsoLinks': [{'url': 'https://www.researchgate.net/publication/336762026_How_to_Calculate_Sample_Size_for_Observational_and_Experimental_Nursing_Research_Studies', 'label': 'Related Info'}, {'url': 'https://hnparaplejicos.sanidad.castillalamancha.es/es/quienessomos/memorias-anuales', 'label': 'Data about the incidence of Spinal Cord Injury'}, {'url': 'https://www.sralab.org/rehabilitation-measures/timed-and-go', 'label': 'Information about Timed Up and Go test'}, {'url': 'https://www.vicon.com/hardware/devices/', 'label': 'Information about Motion Capture System Vicon'}, {'url': 'http://www.seniam.org', 'label': 'Information about the placement of the sensors for surface electromyography'}, {'url': 'https://docs.vicon.com/display/Nexus26/Full+body+modeling+with+Plug-in+Gait', 'label': 'Information about the plug in gait model used in the motion capture system Vicon for the three-dimensional gait analysis'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to assess the course of motor and functional gait recovery induced by Lokomat robot-assisted gait rehabilitation in patients with spinal cord injury. The main question it aims to answer is:\n\nHow does gait motor and functional multilevel recovery progress over time in patients with spinal cord injury?\n\nAssessmets will be conducted at four time points: pre-intervention, mid-intervention, post-intervention, and at 1-month follow-up after the completion of robot-assisted gait rehabilitation. Data will be collected at multiple levels, including:\n\n* Clinical tests\n* Three-dimensional gait analysis with kinematic, kinetic, and electromyographic measurements\n* Maximum isometric strength\n* Nerve conduction parameters', 'detailedDescription': 'Patients with spinal cord injuries referred to the robotics service for gait rehabilitation will complete 40 sessions with robotic devices. An initial assessment will determine the most appropriate device. Patients assigned to the Lokomat will undergo 20 sessions, after which they will be reassessed to determine whether to continue with an additional 20 sessions or switch to a different robotic device, based on medical criteria.\n\nThis study evaluates patient progress during the 40 Lokomat sessions at pre-, mid-, and post-intervention time points. A follow-up assessment will be conducted one month after completion of the Lokomat sessions to evaluate the patient progress without robotic assistance.\n\nA descriptive analysis will be performed to characterize baseline demographic data. Descriptive statistics will also be applied to the following outcome measure groups: functional assessment, robotic gait trainer variables, pain and fatigue scales, and the therapy acceptance questionnaire.\n\nThe relationship between motor evoked potential (MEP) responses, lower extremity motor scores (LEMS), and force production capacity estimated using a musculoskeletal model will be investigated.\n\nMEP responses will be classified into three groups based on responsiveness (normal, delayed, and absent), and LEMS scores will be classified into four groups.\n\nA nonparametric Spearman correlation coefficient will be used to assess the correlation between MEP responses and motor scores. Nonparametric Kruskal-Wallis tests will evaluate whether the mean response differs across the four LEMS groups. For variables that do not meet the assumptions of normality for one-way analysis of variance (ANOVA), Mann-Whitney tests with Bonferroni correction will be used as a post hoc test to determine differences in responsiveness between groups. P values \\<0.05 will be considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients at the National Hospital for Paraplegics who are referred by their physician for robot-assisted gait rehabilitation using the Lokomat and who meet the inclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of spinal cord injury\n* Age 18 to 80 years\n* Ability to follow instructions\n* Legally capable of understanding and signing informed consent\n* Incomplete spinal cord injury (AIS C-D), 2 to 6 months post-injury\n* Level of injury between C5 and L1\n* Moderated spasticity (Ashworth \\<2)\n* Referred by a physician for gait rehabilitation with the Lokomat robot\n\nExclusion Criteria:\n\n* Implanted electronic devices\n* Metal implants in the skull\n* Severe spasticity (Ashworth \\>2)\n* Cutaneous lesions and/or pressure ulcers\n* Joint rigidity\n* Osteoporotic fractures\n* Previous surgeries of the lower limbs\n* Concomitant medical conditions\n* Use of oral anticoagulants\n* Pregnancy\n* History of epilepsy\n* Peripheral nerve injury in the lower extremities\n* Failure or refusal to provide signed informed consent'}, 'identificationModule': {'nctId': 'NCT07440459', 'acronym': 'NIMBLE', 'briefTitle': 'Promoting Neuroplastic Mechanisms With Modeling-based Optimization of a Novel Robot-asisted Walking Rehabilitation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'BioRobotics Group - Spanish National Research Council (CSIC)'}, 'officialTitle': 'Assessing and Modeling the Mechanisms of Recovery During Robot Aided Neurorehabilitation of Walking', 'orgStudyIdInfo': {'id': 'PID2021-123657OB-C31'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with spinal cord injury', 'description': 'This is an observational study of individuals with spinal cord injury admitted to the National Hospital for Paraplegics of Toledo (Spain) who are undergoing robot-assisted gait rehabilitation using the Lokomat.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45004', 'city': 'Toledo', 'state': 'Toledo', 'country': 'Spain', 'facility': 'National Hospital for Paraplegics, Toledo (Spain)', 'geoPoint': {'lat': 39.8581, 'lon': -4.02263}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioRobotics Group - Spanish National Research Council (CSIC)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spanish National Research Council', 'class': 'OTHER_GOV'}, {'name': 'Castilla-La Mancha Health Service', 'class': 'OTHER'}, {'name': 'Hospital Nacional de Parapléjicos de Toledo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}