Nctid:
NCT06229626
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D009128", "term"=>"Muscle Spasticity"}, {"id"=>"D020335", "term"=>"Paraparesis"}, {"id"=>"D020336", "term"=>"Paraparesis, Spastic"}], "ancestors"=>[{"id"=>"D009135", "term"=>"Muscular Diseases"}, {"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D009122", "term"=>"Muscle Hypertonia"}, {"id"=>"D020879", "term"=>"Neuromuscular Manifestations"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D010291", "term"=>"Paresis"}], "browseLeaves"=>[{"id"=>"M12085", "name"=>"Muscle Spasticity", "asFound"=>"Spastic", "relevance"=>"HIGH"}, {"id"=>"M22143", "name"=>"Paraparesis", "asFound"=>"Paraparesis", "relevance"=>"HIGH"}, {"id"=>"M22144", "name"=>"Paraparesis, Spastic", "asFound"=>"Spastic Paraparesis", "relevance"=>"HIGH"}, {"id"=>"M12092", "name"=>"Muscular Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M12079", "name"=>"Muscle Hypertonia", "relevance"=>"LOW"}, {"id"=>"M22619", "name"=>"Neuromuscular Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M20944", "name"=>"Muscle Weakness", "relevance"=>"LOW"}, {"id"=>"M13204", "name"=>"Paresis", "relevance"=>"LOW"}, {"id"=>"T2781", "name"=>"Hereditary Spastic Paraplegia", "asFound"=>"Hereditary Spastic Paraparesis", "relevance"=>"HIGH"}, {"id"=>"T5294", "name"=>"Spastic Paraparesis", "asFound"=>"Spastic Paraparesis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>50}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-11", "completionDateStruct"=>{"date"=>"2026-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-11-21", "studyFirstSubmitDate"=>"2023-12-13", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-11-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group.", "timeFrame"=>"6 weeks", "description"=>"6-minute walk test carried out in the presence of a clinician trained in this test. The patient walks for 6 minutes on a circuit of known distance, identical for each patient. The clinician times the walking time and measures the distance covered during 6 minutes. This test is performed at inclusion and again at 6 weeks"}], "secondaryOutcomes"=>[{"measure"=>"compare the before-after variation in distance covered in 6 minutes", "timeFrame"=>"18 weeks", "description"=>"6-minute walk test carried out in the presence of a clinician trained in this test. This test is performed at inclusion and again at 18 weeks"}, {"measure"=>"compare the before-after variation in walking speed over a 10-meters test", "timeFrame"=>"18 weeks", "description"=>"10-meters test carried out in the presence of a clinician trained in this test. This test is performed at inclusion and again at 18 weeks"}, {"measure"=>"compare the clinical evolution of spasticity", "timeFrame"=>"18 weeks", "description"=>"clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS)"}, {"measure"=>"compare the lower-limb joint amplitudes", "timeFrame"=>"18 weeks", "description"=>"clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale"}, {"measure"=>"compare the patients' mood evolution", "timeFrame"=>"18 weeks", "description"=>"patients' mood evolution using the Hospital Anxiety and Depression (HAD) scale"}, {"measure"=>"compare the evolution of cognitive disorders", "timeFrame"=>"18 weeks", "description"=>"evolution of cognitive disorders using the Cerebellar Cognitive Affective/Schmahmann Syndrome Scale (CCAS)"}, {"measure"=>"compare the before-after variation in the daily number of steps", "timeFrame"=>"18 weeks", "description"=>"before-after variation in the number of steps taken daily under ecological conditions, reported by pedometer"}, {"measure"=>"compare the before-after variation in heart rate", "timeFrame"=>"18 weeks", "description"=>"before-after variation in heart rate during walking assessments (6-minute and 10-meter tests)"}, {"measure"=>"compare the frequency and intensity of vesico-sphincter disorders", "timeFrame"=>"18 weeks", "description"=>"compare the frequency of vesico-sphincter disorders using Neurogenic Bowel Dysfunction sore"}, {"measure"=>"compare the anorectal disorders", "timeFrame"=>"18 weeks", "description"=>"compare the intensity of vesico-sphincter disorders using Urinary Symptom Profile"}, {"measure"=>"compare the quality of life", "timeFrame"=>"18 weeks", "description"=>"compare the quality of life using the EQ5D scale. The EQ-5D is a self-administered questionnaire that measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression."}, {"measure"=>"compare the fatigue", "timeFrame"=>"18 weeks", "description"=>"compare the fatigue using the Modified Fatigue Impact Scale (MFIS)"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["physical rehabilitation program", "hereditary spastic paraparesis"], "conditions"=>["Hereditary Spastic Paraparesis"]}, "descriptionModule"=>{"briefSummary"=>"Hereditary spastic paraparesis is a group of inherited neurological diseases. Only symptomatic treatments exist for the moment. The Modifspa study (cf citation) carried out by the team showed that patients perceived a feeling of effectiveness of physiotherapy on lower limb spasticity. The aim of the Walk-up study is to objectivize this feeling of efficacy on gait disorders in these patients.\n\nThis is an interventional study using physical training. The study is prospective, open, randomized in 2 parallel groups, one of which is a control group. Analyses will be comparative between the 2 groups during the course of the study.", "detailedDescription"=>"Following an initial study carried out by the team (cf citation), physiotherapy appeared to be the most useful therapy for coping with spasticity, particularly when practised at least 3 times a week. The hypothesis is that this feeling experienced by patients is accurate, and that more frequent physiotherapy (3 additional sessions/week) significantly improves patients' walking speed, with a functional objective.\n\nThe main aim of the WALK-UP study is to evaluate the efficacy of a 6-week intensive physical rehabilitation program on walking speed in patients with SPG4 / SPAST-HSP. This is the most frequent genotype in Hereditary Spastic Paraparesis. All patients included in the study will receive at least one physiotherapy session per week in a liberal practice."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patient with molecular diagnosis of hereditary spastic paraparesis based on pathogenic variant of SPAST gene,\n* Walking possible for 6 minutes without human assistance (one or more technical aids are authorized: e.g. cane, walker, orthoses),\n* At least 1 physiotherapy session per week already in place.\n* Understanding of the protocol\n* Possibility of connecting to the Internet from home to access video material provided as part of the protocol.\n\nExclusion Criteria:\n\n* Botulinum toxin injection within 2 months of protocol inclusion\n* Discontinuation of private physiotherapy,\n* Refusal to participate in the protocol,\n* Participation in another interventional clinical trial evaluating a health product or in a randomized clinical trial\n* Pregnant women\n* Not affiliated to a social security scheme or beneficiary of such a scheme\n* Patient under guardianship or trusteeship"}, "identificationModule"=>{"nctId"=>"NCT06229626", "acronym"=>"WALK-up", "briefTitle"=>"Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast", "organization"=>{"class"=>"OTHER", "fullName"=>"Assistance Publique - Hôpitaux de Paris"}, "officialTitle"=>"Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast", "orgStudyIdInfo"=>{"id"=>"APHP230987"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"the reeducation group", "description"=>"The population included in the reeducation group will benefit, in addition to their usual physiotherapy care (at least 1 session per week), from :\n\n* 1 group physiotherapy session per week at the ICM or by videoconference from home for 6 weeks\n* 2 sessions per week at home with video support sent by e-mail for 6 weeks\n\nThese 3 additional video or group sessions will last 30 min. These sessions will be created and adjusted by a physiotherapist and a Physical and Rehabilitation Medicine doctor. They will include exercises such as :\n\n* Stretching\n* posture\n* Muscle strengthening\n* Proprioception\n\nAnd will be performed in standing, sitting and lying positions.", "interventionNames"=>["Other: intensive reeducation"]}, {"type"=>"NO_INTERVENTION", "label"=>"The control group", "description"=>"usual physiotherapy care (at least 1 session per week)"}], "interventions"=>[{"name"=>"intensive reeducation", "type"=>"OTHER", "description"=>"* 1 group physiotherapy session per week at the ICM or by videoconference from home for 6 weeks\n* 2 sessions per week at home with video support sent by e-mail for 6 weeks", "armGroupLabels"=>["the reeducation group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"75013", "city"=>"Paris", "status"=>"RECRUITING", "country"=>"France", "contacts"=>[{"name"=>"Pauline Lallemant, MD", "role"=>"CONTACT", "email"=>"pauline.lallemant@icm-institute.org", "phone"=>"1. 57.27.46.69", "phoneExt"=>"+33"}, {"name"=>"Rania Hilab, CRA", "role"=>"CONTACT", "email"=>"rania.hilab@icm-institute.org", "phone"=>"1. 57.27.46.91", "phoneExt"=>"+33"}, {"name"=>"Pauline Lallemant, MD", "role"=>"CONTACT"}], "facility"=>"ICM, Hôpital Pitié-Salpêtrière", "geoPoint"=>{"lat"=>48.85341, "lon"=>2.3488}}], "centralContacts"=>[{"name"=>"Pauline Lallemant, MD", "role"=>"CONTACT", "email"=>"pauline.lallemant@icm-institute.org", "phone"=>"1. 57.27.46.69", "phoneExt"=>"+33"}, {"name"=>"Rania Hilab, CRA", "role"=>"CONTACT", "email"=>"rania.hilab@icm-institute.org", "phone"=>"1. 57.27.46.91", "phoneExt"=>"+33"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Assistance Publique - Hôpitaux de Paris", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
