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Test of Aquatic Mobility of SMA Infants

RecruitingNAAges any - 12 MonthsAllAssistance Publique - Hôpitaux de Paris
NCT06152302 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Spinal muscular atrophy (SMA) is a genetic neurodegenerative disease impacting spinal cord motor neurons, leading to motor and respiratory issues and, ultimately, death. With emerging therapies, a need arises to enhance motor function assessment in severely hypotonic infants (SMA type 1) as traditional scales on examination tables lack completeness due to gravity's influence. The study team has developed a "bath test" to observe infants' motor skills in water, eliminating gravity's effects. This test aims to detect subtle movements using inertial sensors, potentially revealing more active motor neurons in aquatic conditions. It aids in identifying infants with motor improvement potential, even if they show limited mobility outside water, and tracks disease progression and therapy responses. Presently, pediatric neurologists in France use parent-provided bathing videos for evaluations,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Infants with muscle weakness (commonly referred to as floppy babies): * Confirmed diagnosis of SMA through gene mutation or deletion (SMN1 gene). * Receiving standard care. * Age less than 12 years and a height of less than 90 cm at the time of inclusion. * Patients enrolled in a social security scheme. * Informed consent signed by both parents of the child and the investigator. Exclusion Criteria: * Patients presenting with lesions in the spinal cord or conditions affecting the cardiorespiratory system. * Patients covered under the French Aid in Health for Foreign People program (AME).
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What it tests

  • Mobility study in dry conditions
  • Mobility study in water conditions
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Where

1 site
Infantile neuromuscular unity - Department of paediatric neurological care and intentive care unity, Raymond Poincaré Hospital - APHP
Garches, France
🤝 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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