Knee Arthritis Clinical Trial
Official title:
Phase 2 Randomized Clinical Trial, Efficy of a Proprioceptive Stimulation Device in Term of Prevention of Muscle Atrophy of the Calf After Total Knee Replacement
Confinement to bed, which occurs in many pathological situations, induces a muscle atrophy
and a loss of muscle strength. Muscle atrophy is associated to impaired performance in motor
tasks, such as posture and locomotion, and is therefore a major cause of loss of autonomy.
It requires a stay in follow-up and rehabilitation service, and thus lengthens the duration
of hospitalisation.
Data underline the importance of afferent input integrity in the maintenance of muscle
characteristics and postural control, and suggest that countermeasure programs based on the
stimulation of proprioceptive inputs could be efficient to prevent muscle atrophy and falls.
In particular, fundamental studies performed in rodents by the investigators laboratory have
demonstrated that the adverse structural and functional adaptations which occur during
muscle deconditioning can be counteracted through adequate physiological stimuli such as
activation of proprioceptors. Based on this scientific expertise, the investigators aim is
thus to prevent muscle atrophy and its functional consequences on posture and locomotion,
following a surgical intervention in humans .
The investigators will develop a device allowing stimulation of foot and ankle
proprioceptors. In order to facilitate the evaluation of its efficiency, the device will be
tested on a selected population confined to bed during a post-operative period (knee
replacement). It efficiency will be evaluated by means of three parameters: muscle force of
ankle plantar flexor, muscle volume of lower limb muscles, functional outcome (gait and
balance analysis).
The technique developed in the present project could bring benefits to patients confined to
bed, or in elderly. Preventing or retarding development of muscle atrophy will beneficiate
to health and quality of life of these patients. In addition, this device might allow to
consider therapeutic strategies for prevention of atrophy in neuromuscular pathologies.
The aim of the study is to study the efficacy of a proprioceptive stimulation device on
prevention of calf muscle atrophy after a total knee replacement.
The investigators developped a safe vibration and pressure stimulation device for le lower
limb. The investigators want to carry out a RCT in order to demonstrate the efficacy of the
stimulation device, compared to a not stimulated controle group.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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