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A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients

RecruitingNAAges any - 21 YearsAllWiktor Dega University Orthopedic and Rehabilitat…
NCT06322654 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 years 2. 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Signing of informed consent to participate in the experiment by the participant or the participant's parent/legal guardian * Diagnosis of SMA (spinal muscular atrophy 1-4) confirmed by genetic testing, symptomatic or pre-symptomatic * Age between 0 and 21 years of age (will be determined on the day of starting participation in the project based on the date of birth) * Treatment under a drug program for spinal muscular atrophy, provided that the patient has a diagnosis of spinal muscular atrophy at the date of eligibility. Exclusion Criteria: * Cardio-respiratory disorders requiring invasive ventilation * Advanced osteoporosis with multiple fractures prior to treatment * Functional deterioration during the rehabilitation process in the range of scales appropriately selected for the SMA type: Prechtl, HINE, CHOP-INTEND, HFMS, RULM * Lack of cooperation with the therapist * Other functional indications preventing exercise
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What it tests

  • Robotically Assisted Locomotion
  • Robotically Assisted Verticalization
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Where

1 site
Wiktor Dega University Orthopedic and Rehabilitation Hospital
Poznan, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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