Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy

NCT01641627 | Completed Phase 1 DMC

• 2 other identifiers: 2010_052011-A0031-40
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthritis

Keywords

knee arthritis; muscle atrophy; proprioceptive stimulation; vibrations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Volume of the Soleus muscle

  1.5 years

Study Arms (1)

vibration

EXPERIMENTAL

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

Procedure: proprioceptive stimulation

Interventions

proprioceptive stimulation PROCEDURE

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

Also known as: therapeutic boots, vibration boots

vibration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients waiting for knee replacement

You may not qualify if:

• neurologic disease

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHRU de Lille

Lille, Nord, 59037, France

Location

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• vincent TIFFREAU, MD-PhD

  Univerity Hospital Lille 2

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: July 17, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

FR (1)