Ortheses are commonly used for the repair of damage to the musculoskeletal system. However, immobility, by itself, causes serious side effects that require long and costly rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the proprioceptive and tactile flow in order to maintain the activity of their host brain areas and thus reduce significantly the usual therapy duration. The clinical study Orthosens will evaluate the efficacy and safety of the Sensory Feedback Ortheses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
104
with active vibration
with placebo vibration
Clinique Axium
Aix-en-Provence, France
Institut de Chirurgie Orthopédique et Sportive
Marseille, France
Hôpital Sainte-Marguerite
Marseille, France
Period of time required to recover a normal knee range of motion
Period of time required to recover a normal knee range of motion with a passive mobilization
Time frame: The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)
Pain according to Visual Analogic Scale
Time frame: The day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)
Safety according to adverse event records
Time frame: At any time during subject participation (12 weeks)
Psychological state according to the Incredibly Short Profile of Mood States
Time frame: 3 times per week from week 1 to week 12
Knee functional state according to IKDC, KOOS and KOOS-PS scores
Time frame: The Day of inclusion, then 3 times per week during 12 weeks (except at weeks 8 and 12: 4 measurements)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.