Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Knee Arthritis

Intervention / Treatment
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* Procedure: proprioceptive stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients waiting for knee replacement Exclusion Criteria: neurologic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vibration<br>proprioceptive stimulation of the lower limb using vibration and plantar pressure boots | Procedure: proprioceptive stimulation<br>* tendon vibrations and plantar stimulation with a therapeuthic orthosis, 4x30 min/day during 14 days<br>* Other names: therapeutic boots, vibration boots;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Isokinetic Maximal Voluntary strenght of the plantar floxors of the ankle. The outcome measure is assessed using an isokinetic strength assesment device (CON-TREX , CVM-AG, Switzerland) | The patients will perform series of maximal contraction of the plantar flexors against the lever arm of the isokinetic device at 3 different angular speeds : 180°/s 90°/s, 120°/sec | 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of the Soleus muscle | Ultrasound measurement of the soleus muscle volume | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee arthritis, muscle atrophy, proprioceptive stimulation, vibrations