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Clinical Trials in France / NCT06152302
Recruiting Not applicable

Test of Aquatic Mobility of SMA Infants

NCT06152302 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2025-06-26
Last updated
2025-11-21

Condition(s) studied

Infantile Spinal Muscular Atrophy

Investigational drug(s) / intervention(s)

Mobility study in dry conditionsMobility study in water conditions

Mobility study in dry conditions: Record the movements of the baby's extremities using inertial sensors while the baby moves outside of the water.

Mobility study in water conditions: Record the movements of the baby's extremities using inertial sensors while the baby moves inside the water.

Study 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

Sex
ALL
Min age
—
Max age
12 Months
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Delta of 95th percentile of free acceleration norm (in m/s²) — through study completion, an average of 15 months
    Difference of free acceleration norm (in m/s²) for each measurement point respectively (elbows; wrists; knees; ankles), between "dry" and "water" condition.

Trial sites (1)

FacilityCityRegionStatus
Infantile neuromuscular unity - Department of paediatric neurological care and intentive care unity, Raymond Poincaré Hospital - APHP Garches France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06152302 on ClinicalTrials.gov ↗ ← All trials in France