Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy

Knee Arthritis Clinical Trial

— PrevAtrophy  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641627
• Other study ID #: 2010_05
• Secondary ID: 2011-A0031-40
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 22, 2012
• Last updated: April 8, 2015
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients waiting for knee replacement

Exclusion Criteria:

• neurologic disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthritis
• Muscular Atrophy

Intervention

Procedure:
• proprioceptive stimulation
tendon vibrations and plantar stimulation with a therapeuthic orthosis, 4x30 min/day during 14 days

Locations

Country	Name	City	State
France	CHRU de Lille	Lille	Nord

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Volume of the Soleus muscle	Ultrasound measurement of the soleus muscle volume	1.5 years	No