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Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy (PrevAtrophy)

Primary Purpose

Knee Arthritis

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
proprioceptive stimulation
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthritis focused on measuring knee arthritis, muscle atrophy, proprioceptive stimulation, vibrations

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients waiting for knee replacement

Exclusion Criteria:

  • neurologic disease

Sites / Locations

  • CHRU de Lille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vibration

Arm Description

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

Outcomes

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)
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
Ultrasound measurement of the soleus muscle volume

Full Information

First Posted
May 22, 2012
Last Updated
April 8, 2015
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT01641627
Brief Title
Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis
Keywords
knee arthritis, muscle atrophy, proprioceptive stimulation, vibrations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vibration
Arm Type
Experimental
Arm Description
proprioceptive stimulation of the lower limb using vibration and plantar pressure boots
Intervention Type
Procedure
Intervention Name(s)
proprioceptive stimulation
Other Intervention Name(s)
therapeutic boots, vibration boots
Intervention Description
tendon vibrations and plantar stimulation with a therapeuthic orthosis, 4x30 min/day during 14 days
Primary Outcome Measure Information:
Title
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)
Description
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
Time Frame
1.5 year
Secondary Outcome Measure Information:
Title
Volume of the Soleus muscle
Description
Ultrasound measurement of the soleus muscle volume
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients waiting for knee replacement Exclusion Criteria: neurologic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
vincent TIFFREAU, MD-PhD
Organizational Affiliation
Univerity Hospital Lille 2
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Lille
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

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Preventive Effect of Proprioceptive Stimulation on Muscle Atrophy

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