Actively Recruiting
Test of Aquatic Mobility of SMA Infants
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-21
15
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Test of Aquatic Mobility of SMA Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants with muscle weakness (floppy babies) confirmed by SMA diagnosis via SMN1 gene mutation or deletion
- Receiving standard care for SMA
- Age less than 12 months and height under 90 cm at inclusion
- Enrolled in a social security health scheme
- Signed informed consent from both parents and investigator
You will not qualify if you...
- Presence of spinal cord lesions or cardiorespiratory system conditions
- Participation in the French Aid in Health for Foreign People (AME) program
AI-Screening
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Trial Site Locations
Total: 1 location
1
Infantile neuromuscular unity - Department of paediatric neurological care and intentive care unity, Raymond Poincaré Hospital - APHP
Garches, France, 92380
Actively Recruiting
Research Team
S
Susana Quijano-Roy, MD, PhD
CONTACT
N
Nour Maalouf, Psychomotor Therapist DE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
FACTORIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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