[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573162":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":71,"collaborators":20,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":20,"enrollmentInfo":83,"targetDuration":20,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"IRCCS Eugenio Medea","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HSP Cohort","EXPERIMENTAL","The whole cohort of HSP patients will receive the same comprehensive neurorehabilitation program aiming at improving gait capabilities (speed and endurance). The content and the dosis of the treatment will be personalized according to patient's specific needs and preferences.",[13],"Behavioral: Flexibility, Resistance, Aerobic, Movement Execution training",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Flexibility, Resistance, Aerobic, Movement Execution training","Flexibility: static and dynamic stretching combined with sensory, high-frequency electrical stimulation to reduce spasticity and improve mobility.\n\nResistance training: core stability and lower limb strength training in conditions of instability, to improve strength, coordination, and balance.\n\nMovement execution training: gait training according to motor learning principles.\n\nAerobic exercise: in the form of high-intensity interval training at the end of each session, to improve cardiovascular status and foster motor learning consolidation (probably due to the release of brain derived neurothrophic factors).",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Leonardo Boccuni, PhD","Scientific Institute, IRCCS E. Medea, Department of Conegliano, Treviso, Italy.","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","003904384141","leonardo.boccuni@lanostrafamiglia.it",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Marco Bortolini, BSc","003904389062","marco.bortolini@lanostrafamiglia.it",[36,57],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Scientific Institute, IRCCS E. Medea, Department of Bosisio Parini, Lecco, Italy.","RECRUITING","Bosisio Parini","Lombardy","23842","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],9.29,45.80075,{"lat":48,"lon":47},[51,55,56],{"name":52,"role":28,"phone":53,"phoneExt":20,"email":54},"Eleonora Diella, BSc","0039031877589","eleonora.diella@lanostrafamiglia.it",{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":52,"role":25,"phone":20,"phoneExt":20,"email":20},{"facility":58,"status":38,"city":59,"state":60,"zip":61,"country":42,"countryCode":43,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Scientific Institute, IRCCS E. Medea, Department of Pieve di Soligo, Treviso, Italy","Pieve di Soligo","Veneto","31053",{"type":45,"coordinates":63},[64,65],12.17128,45.89836,{"lat":65,"lon":64},[68,69,70],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":72,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100573162","flexibility-resistance-aerobic-movement-execution-training-in-adults-with-hereditary-spastic-paraplegia-100573162",false,"NCT06742697","Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia","Flexibility, Resistance, Aerobic, Movement Execution (FRAME) Training Program to Improve Gait Capacity in Adults With Hereditary Spastic Paraplegia: Protocol for a Single-cohort Feasibility Trial","FRAME","Inclusion Criteria:\n\n* Adults diagnosed with Hereditary Spastic Paraplegia.\n* Presence of any functional deficit in the lower limbs that affects walking, such as muscle weakness, hypertonia, or balance issues.\n* Ability to walk without the need for physical contact with another person, as defined by a Functional Ambulation Category score of 3 or higher.\n* Ability to understand simple instructions, comprehend the purpose of the study, willingness to participate and undergo at least 10 treatment sessions, eligible and willing to sign the informed consent.\n\nExclusion Criteria:\n\n* Botulinum toxin or surgery to treat lower limb hypertonia in the six months prior to enrollment in the study.\n* Contraindications for moderate physical activity, such as stretching exercises, muscle strength training, and aerobic capacity training.","ALL","18 Years",{"count":84,"type":85},20,"ESTIMATED","INTERVENTIONAL",[88],"NA","Hereditary Spastic Paraplegia (HSP) is a diverse group of genetic neurological conditions causing progressive weakness and spasticity in the lower limbs, severely reducing balance and gait capabilities. There is currently a lack of structured neurorehabilitation programs aimed at improving gait in adults with HSP. This protocol seeks to assess the feasibility and effectiveness of a structured training approach focusing on flexibility, muscle strength, motor control, balance, and aerobic capacity.\n\nTo this end, twenty adults diagnosed with HSP will engage in 10 to 16 sessions, each lasting 60 to 120 minutes, guided by a therapist once or twice a week, depending on individual preferences. At the end of the program, participants will receive a transfer package, including written instructions (a manual) and video tutorials, to encourage ongoing exercise at home. Assessments will occur before the intervention (T0), immediately after (T1), and three months later (T2). The primary outcomes will measure the feasibility of the program, including recruitment, retention, adherence, the absence of adverse events, and patient satisfaction. Secondary outcomes will focus on improvements in gait capabilities such as gait endurance and gait speed.",[91],"Hereditary Spastic Paraplegia",[93,94,95,96,97,98,99,100,101,102,103,104,105],"feasibility","gait","endurance","speed","balance","neurorehabilitation","hereditary spastic paraplegia","motor learning","aerobic exercise","high intensity interval training","resistance training","flexibility training","gait training","2025-01-28",{"date":108,"type":109},"2025-01-30","ACTUAL",{"date":111,"type":109},"2024-12-23",{"date":113,"type":85},"2027-04",{"name":5,"class":6},2]