PrevAtrophy: Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT01641627

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthritis	Procedure: proprioceptive stimulation	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vibration proprioceptive stimulation of the lower limb using vibration and plantar pressure boots	Procedure: proprioceptive stimulation tendon vibrations and plantar stimulation with a therapeuthic orthosis, 4x30 min/day during 14 days Other Names: therapeutic boots, vibration boots

Arm

Intervention/Treatment

Experimental: vibration

proprioceptive stimulation of the lower limb using vibration and plantar pressure boots

Procedure: proprioceptive stimulation

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

Other Names:

therapeutic boots, vibration boots

Outcome Measures

Primary Outcome Measures

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) [1.5 year]
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

Secondary Outcome Measures

Volume of the Soleus muscle [1.5 years]
Ultrasound measurement of the soleus muscle volume

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients waiting for knee replacement

Exclusion Criteria:

neurologic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Lille	Lille	Nord	France	59037

Sponsors and Collaborators

University Hospital, Lille

Investigators

Principal Investigator: vincent TIFFREAU, MD-PhD, Univerity Hospital Lille 2

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Lille

ClinicalTrials.gov Identifier:

NCT01641627

Other Study ID Numbers:

2010_05
2011-A0031-40

First Posted:

Jul 17, 2012

Last Update Posted:

Apr 9, 2015

Last Verified:

Apr 1, 2015

Keywords provided by University Hospital, Lille

knee arthritis

muscle atrophy

proprioceptive stimulation

vibrations

Additional relevant MeSH terms:

Arthritis

Muscular Atrophy

Atrophy

Study Results

No Results Posted as of Apr 9, 2015