NCT06152302 Test of Aquatic Mobility of SMA Infants
| NCT ID | NCT06152302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Infantile Spinal Muscular Atrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-06-26 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-06-26 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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, but these lack standardization and precision. The study aims to establish a standardized evaluation protocol with quantifiable data. The study's key objective is to evaluate severely hypotonic SMA infants using inertial sensors, including accelerometers, gyrometers, and magnetometers. The study will conduct "dry" and "water" assessments using a specially designed bathtub. This method's goal is to quantify water-based movements accurately. Simultaneously, the study seeks to establish semi-quantitative evaluation criteria to create a clinical assessment scale for infant motor function in bathtubs. This scale will aid doctors in therapeutic decisions. The study will not influence the treatment or therapeutic decisions made for the children being tested. Collected data from "dry" and "water" conditions will be statistically analyzed and compared to reference motor assessment scales (e.g., CHOP INTEND and HINE) and electromyography (CMAP-EMG) results, commonly used in diagnosis and monitoring. Blurred video recordings will assist in protocol monitoring and sensor data analysis.
Eligibility Criteria
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).
Contact & Investigator
Susana Quijano-Roy, MD, PhD
PRINCIPAL INVESTIGATOR
Paediatric neurological and intentive care unity, Raymond Poincaré Hospital - APHP
Frequently Asked Questions
Who can join the NCT06152302 clinical trial?
This trial is open to participants of all sexes, up to 12 Months, studying Infantile Spinal Muscular Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06152302 currently recruiting?
Yes, NCT06152302 is actively recruiting participants. Contact the research team at susana.quijano-roy@aphp.fr for enrollment information.
Where is the NCT06152302 trial being conducted?
This trial is being conducted at Garches, France.
Who is sponsoring the NCT06152302 clinical trial?
NCT06152302 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Susana Quijano-Roy, MD, PhD at Paediatric neurological and intentive care unity, Raymond Poincaré Hospital - APHP. The trial plans to enroll 15 participants.