protocolSection identificationModule nctId: NCT06322654, orgStudyIdInfo id: 2023/ABM/01/00004/P/02, briefTitle: A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients, acronym: SMArt, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-21, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Wiktor Dega University Orthopedic and Rehabilitation Hospital, class: OTHER, descriptionModule briefSummary: A head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with SMA. A single-center, randomized, single-blinded, comparative study of Robotically Assisted Verticalization versus Robotically Assisted Locomotion.The objective of research:The main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with SMA depending on age and baseline functional status. The study consists of a head-to-head comparison of two rehabilitation models.1. Research period: 4 years2. Patients age: 0-21 y.o.3. Group size: 200 patients (100 patients in each group)4. Assignment of patients to study groups in a randomised manner, conditionsModule conditions: SMA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two research groups with 100 patients in each group.1. Experimental: Robotically Assisted Locomotion2. Comparison: Robotically Assisted Verticalization, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Patients and their parents will not be blinded by the nature of the therapeutic procedure used after random allocation to the treatment group. Study personnel will be divided into Blinded Team and Unblinded Team to ensure objectivity of the assessment of safety and effectiveness of both strategies., whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Robotically Assisted Locomotion, interventions name: Robotically Assisted Verticalization, outcomesModule primaryOutcomes measure: Clinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale, primaryOutcomes measure: Clinical assessment of patients using Balance test minimum 1 min., Self-walk test of at least 2 meters, 6-minute gait test, Up&Go test, 10 meters gait test, hip range of motion and muscle strength evaluation., primaryOutcomes measure: Functional assessment of patients using GMFM (Gross Motor Function Measure) scale, primaryOutcomes measure: X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density, primaryOutcomes measure: Assessment of the quality of life of patients and their caregivers using Pediatric Quality of Life Inventory ver. 4.0, secondaryOutcomes measure: Hospitalization during or between rehabilitations that take place each 6 months, secondaryOutcomes measure: Occurence of discomfort during therapy requiring abrupt interruption or significant modification, secondaryOutcomes measure: Number of fractures, eligibilityModule sex: ALL, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Wiktor Dega University Orthopedic and Rehabilitation Hospital, status: RECRUITING, city: Poznań, zip: 61-545, country: Poland, contacts name: Marek Jóźwiak, role: CONTACT, phone: 696052475, phoneExt: +48, email: sma@orsk.pl, contacts name: Radosław Rutkowski, role: CONTACT, phone: 696052475, email: sma@orsk.pl, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False