[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640039":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":25,"responsibleParty":37,"collaborators":25,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":66,"whyStopped":25,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":25},{"fullName":5,"class":6},"Istanbul Medipol University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group - Conventional Rehabilitation","ACTIVE_COMPARATOR","Participants in this arm will receive a standard neurorehabilitation program for paraplegia secondary to spinal cord injury. The program will include stretching exercises, progressive strengthening exercises, balance training, and transfer training. Sessions will be conducted 3 days per week, 45-60 minutes per session, for a total duration of 8 weeks. No Functional Electrical Stimulation (FES) will be applied in this group.",[13],"Other: Conventional Neurorehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"FES + Conventional Rehabilitation Group","EXPERIMENTAL","Participants in this arm will receive the same standard neurorehabilitation program as the control group, including stretching, strengthening, balance, and transfer training (3 days per week, 45-60 minutes per session for 8 weeks). In addition, Functional Electrical Stimulation (FES) will be applied to the quadriceps femoris muscle. FES parameters will include 35 Hz frequency, 300 µs pulse duration, and a 10-second on \u002F 20-second off cycle. FES will be administered 5 days per week for 8 weeks to facilitate neuromuscular activation, improve muscle strength, and reduce spasticity.",[19],"Device: Functional Electrical Stimulation (FES) of Quadriceps Muscle",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Conventional Neurorehabilitation","This intervention consists of a conventional neurorehabilitation program designed for individuals with paraplegia secondary to spinal cord injury. The program includes stretching exercises, progressive strengthening exercises, balance training, and transfer training. Sessions are conducted 3 days per week, 45-60 minutes per session, over a total duration of 8 weeks. This group does not receive Functional Electrical Stimulation (FES). The intervention is aimed at improving general motor function, maintaining joint range of motion, and enhancing functional independence.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","Functional Electrical Stimulation (FES) of Quadriceps Muscle","This intervention consists of Functional Electrical Stimulation (FES) applied to the quadriceps femoris muscle in addition to the same conventional neurorehabilitation program provided to the control group. FES is delivered using a neuromuscular electrical stimulation device to induce muscle contractions via peripheral nerve activation. Stimulation parameters include 35 Hz frequency, 300 µs pulse duration, and a 10-second on \u002F 20-second off cycle. The intervention is applied 5 days per week for 8 weeks. The aim is to enhance neuromuscular activation, reduce spasticity, increase quadriceps muscle strength, and improve functional mobility in individuals with paraplegia.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Mehmet Salih TAN, Doctorate","CONTACT","+905467266876","mstan@medipol.edu.tr",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","salih tan","Istanbul Medipol University","100640039","effects-of-functional-electrical-stimulation-on-spasticity-quadriceps-muscle-strength-and-functional-mobility-in-individuals-with-paraplegia-100640039",false,"NCT07583576","Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia","Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia: A Randomized Controlled Trial","FES-PAR-RCT","Inclusion Criteria:\n\n* Participants will be included in the study if they meet all of the following criteria:\n* Aged between 18 and 65 years\n* Diagnosed with spinal cord injury resulting in paraplegia (traumatic or non-traumatic etiology)\n* Classified as ASIA Impairment Scale C or D\n* Medically stable condition\n* Presence of lower extremity spasticity (Modified Ashworth Scale ≥ 1)\n* Ability to understand and follow simple instructions\n* Willingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* Participants will be excluded if they present any of the following conditions:\n* Presence of cardiac pacemaker or implanted electrical device\n* Severe cognitive impairment or communication difficulties preventing participation\n* Active infection or systemic inflammatory condition\n* Severe lower extremity contractures or deformities limiting movement\n* Dermatological conditions or open wounds preventing FES application\n* History of severe autonomic dysreflexia triggered by electrical stimulation\n* Uncontrolled medical conditions that may interfere with participation or safety","ALL","18 Years","65 Years",{"count":53,"type":54},40,"ESTIMATED","INTERVENTIONAL",[57],"NA","Spinal cord injury (SCI)-related paraplegia is a complex neurological condition characterized by motor impairment, increased spasticity, and significant functional limitations in daily activities. Spasticity is one of the most common secondary complications after upper motor neuron lesions and can negatively affect rehabilitation outcomes, gait ability, and functional independence.\n\nThis randomized controlled study aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Participants will be randomly assigned to either a control group receiving conventional neurorehabilitation or an intervention group receiving additional FES treatment.\n\nThe primary outcomes include changes in spasticity level, quadriceps muscle strength, and functional mobility. Spasticity will be assessed using the Modified Ashworth Scale (MAS), muscle strength will be evaluated with Manual Muscle Testing (MMT), and functional mobility will be measured using the Spinal Cord Independence Measure (SCIM), Timed Up and Go Test (TUG), and 6-Minute Walk Test (6MWT).\n\nThe intervention period will last 8 weeks, with standardized rehabilitation programs applied to both groups. The FES group will additionally receive quadriceps stimulation with specific neuromuscular electrical stimulation parameters.\n\nThe findings of this study are expected to provide evidence regarding the effectiveness of FES as an adjunct to conventional rehabilitation in improving motor function and functional independence in individuals with paraplegia.",[60,61,62,63],"Spinal Cord Injury","Paraplegia","Spasticity","Neurorehabilitation",[60,65,63,62,61],"Paraplegia Rehabilitation","NOT_YET_RECRUITING","2026-05-15",{"date":69,"type":70},"2026-05-19","ACTUAL",{"date":72,"type":54},"2026-05-10",{"date":74,"type":54},"2026-07-10",{"name":5,"class":6}]