protocolSection identificationModule nctId: NCT06321172, orgStudyIdInfo id: 785, briefTitle: Muscle and Bone Changes After 6 Months of FES Cycling, acronym: FES-Bike, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-09-09, primaryCompletionDateStruct date: 2024-01-22, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, collaborators name: Politecnico di Milano, collaborators name: Villa Beretta Rehabilitation Center, collaborators name: National Research Council, descriptionModule briefSummary: The goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles, training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training. The main question\[s\] it aims to answer are:* Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling? If any, the morpho-functional improvements are maintained one month after the end of the training?* Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling?* Does the training performance improve during the training with FES cycling?* Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling? If yes, the changes in the vegetative nervous system are maintained one month after the end of the training?* Does the intestinal function change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?* Does the pilots' motivation in carrying out a sporting activity change between T1 (3 months after starting the training) and T2(6 months after starting the training)?Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation., conditionsModule conditions: Spinal Cord Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: FES Bike, outcomesModule primaryOutcomes measure: Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, secondaryOutcomes measure: Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, secondaryOutcomes measure: Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, secondaryOutcomes measure: Changes in bone quality, secondaryOutcomes measure: Changes in data referring to the vegetative nervous system, secondaryOutcomes measure: Changes in data referring to the vegetative nervous system, secondaryOutcomes measure: Changes in data referring to the vegetative nervous system, secondaryOutcomes measure: Changes in the intestinal function, secondaryOutcomes measure: Changes in the intestinal function, secondaryOutcomes measure: Changes in the intestinal function, secondaryOutcomes measure: Changes in the level of spasticity of the lower limbs, secondaryOutcomes measure: Changes in the level of spasticity of the lower limbs, secondaryOutcomes measure: Changes in the level of spasticity of the lower limbs, secondaryOutcomes measure: Changes in the level of pain perceived, secondaryOutcomes measure: Changes in the level of pain perceived, secondaryOutcomes measure: Changes in the level of pain perceived, secondaryOutcomes measure: Changes in the General Well Being of the pilots while training, secondaryOutcomes measure: Changes in the General Well Being of the pilots while training, secondaryOutcomes measure: Changes in the General Well Being of the pilots while training, secondaryOutcomes measure: Pilots' motivation in carrying out a sporting activity, secondaryOutcomes measure: Pilots' motivation in carrying out a sporting activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientific Institute, IRCCS E. Medea, city: Bosisio Parini, state: Lecco, zip: 23842, country: Italy, geoPoint lat: 45.80075, lon: 9.29, hasResults: False