Aquatic mobility test for infants with SMA
Analysis of Mobility in the Bath for Infants Affected With Spinal Muscular Atrophy
NA · Assistance Publique - Hôpitaux de Paris · NCT06152302
This project will test whether a standardized bath test with wearable inertial sensors can reveal hidden motor abilities in infants with type 1 spinal muscular atrophy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Garches) |
| Trial ID | NCT06152302 on ClinicalTrials.gov |
What this trial studies
This multicenter French project will compare infant mobility in standardized dry and in-water conditions using a 'bath test' protocol combined with wearable inertial sensors to detect subtle movements. Infants with genetically confirmed SMA type 1 will be recorded during routine follow-up visits at three pediatric neurology centers coordinated by Raymond Poincaré Hospital. The protocol aims to standardize recording conditions, quantify water-assisted movements, and track changes over time or after therapies. Parental consent is required and common exclusions include spinal cord lesions and significant cardiorespiratory disease.
Who should consider this trial
Good fit: Infants with genetically confirmed SMA type 1 (onset before 6 months), under 12 years and shorter than 90 cm, receiving standard care, and whose parents provide informed consent are ideal candidates.
Not a fit: Infants with spinal cord lesions, significant cardiorespiratory disease, those covered by the AME program, or children who already demonstrate sufficient mobility on land may not gain additional information from this test.
Why it matters
Potential benefit: If successful, this could reveal previously undetected motor activity and provide a standardized way to track progression or treatment response in severely hypotonic SMA infants.
How similar studies have performed: Pediatric neurologists have used parent-provided bath videos anecdotally and there is emerging interest, but a standardized sensor-based aquatic mobility test is largely novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Garches
- Infantile neuromuscular unity - Department of paediatric neurological care and intentive care unity, Raymond Poincaré Hospital - APHP — Garches, France (RECRUITING)
Study contacts
- Principal investigator: Susana Quijano-Roy, MD, PhD — Paediatric neurological and intentive care unity, Raymond Poincaré Hospital - APHP
- Study coordinator: Susana Quijano-Roy, MD, PhD
- Email: susana.quijano-roy@aphp.fr
- Phone: + 33 1 47 10 78 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infantile Spinal Muscular Atrophy, SMA, infantile, bath test, water mobility test, inertial sensors, floppy infant, Garches