Pilot Study of an Innovative Physiotherapy in Patients With Infantile Spinal Muscular Atrophy (SMA) (NCT02061189) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study of an Innovative Physiotherapy in Patients With Infantile Spinal Muscular Atrophy (SMA)
France19 participantsStarted 2014-03
Plain-language summary
This clinical trial aims to test a new physio-therapeutic approach tailored to type 2 and 3 Spinal Muscular Atrophy patients, based on physical training in swimming-pool. This specific exercise should promote motor skills of trained patients, as we have observed in different mouse models. Patient's motor skills will be assessed using different scales including MFM and Hammersmith.
This clinical trial attempts to develop a new non-invasive motor scale with sophisticated instruments.
This scale will be useful in future clinical trials on SMA, given the lack of sensitivity of currently available scales.
In addition, the study attempts to validate a questionnaire on post-exercise physical well-being.
Who can participate
Age range5 Years – 10 Years
SexALL
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Inclusion criteria
✓. Patient with type II SMA who can sustain a sitting position without orthopedic corset or type III SMA, with genetic confirmation of the disease.
✓. Age from 5 to 10 years old.
✓. Patient able to understand and execute training instructions, and perform predetermined movements.
✓. Patient able to achieve physical exercises in a swimming pool.
✓. MFM score \> 35.
✓. Patient having any contraindication to physical rehabilitation in a swimming pool.
✓. Consent signed by the holders of parental responsibility for children participating in the study.
✓. Patient with social security insurance.
Exclusion criteria
✕. Pneumonia: the inclusion is to be delayed for at least 3 months after recovery of infection.
✕
What they're measuring
1
Motor function measurement (MFM)
Timeframe: 18 months (control group) to 36 months maximum (swimming pool group)
✕. Patient undergoing a major surgery during the study: spinal fusion.
✕. Patient under the care of a guardian.
✕. Inability to cooperate.
✕. Medication potentially interfering with the SMA (i.e., riluzole, salbutamol, phenylbutyrate, sodium valproate) started less than 6 months before inclusion.