Immediate Effect of Postural Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia (VIBR-AVC)

June 8, 2015 updated by: Rennes University Hospital

Immediate Effect of Cervical Posterior Muscles' and Gluteus Medius Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia

Balance disorders are very common after strokes and often last for long periods of time. Their origin is multifactorial and their impact on the daily lives of patients are particularly important, especially on gait.

The vibration technology for rehabilitation was already studied in static posture with force plats but their impact on gait have yet to be evaluated.

This present study aims at investigating the effects of vibrations applied by an approved medical device to the posterior neck muscles and the gluteus medius - major actors of proprioception and posture mechanisms - on gait disorders in patients with hemiplegia during the chronic phase after stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An inclusion medical exam will occur in order to explain the protocol to the patients, to receive their written informed consent and to check the inclusion and absence of non-inclusion criteria.

The study visit will happen in a 2 weeks' time span at most after the inclusion exam.

During the study visit, the patients will undergo:

  • A quantitative gait analysis with Gait Rite and Optitrack before any intervention;

  • Then, in a randomized order:

    • A vibration stimulation on a non-postural muscle (biceps brachii muscle) in order to get a control stimulation (or "sham") with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped,
    • A vibration stimulation of the posterior neck muscles on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. The precise stimulation location will be located by the pressures centre deviation on a medio-lateral axis on a strength platform (this area can vary for a few centimetres from patient to patient),
    • In order to assess the secondary outcome aiming at defining the best stimulation location, a vibration stimulation of the gluteus medius on the hemiplegic side, with a new gait analysis with Gait Rite and Optitrack during the stimulation, then 2 and 10 minutes after it stopped. In the same way than for the neck muscles, the scouting of the precise location will be assessed facing the greater trochanter by the pressures centre deviation on a medio-lateral axis on a strength platform.

The realisation of the entire protocol will last approximately 90 minutes.

At the end of the test, an optoelectronic recording by Optitrack will be realised on a treadmill in order to highlight potential differences between the gait on the ground and trained gait at comfortable speed for 2 minutes maximum.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Brittany
      • Rennes, Brittany, France, 35000
        • CHU Rennes - Pontchaillou Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Hemiplegic subjects after stroke:

  • Men or women aged over 18
  • Stroke due to ischemic or haemorrhagic cause
  • More than 6 months after stroke
  • First episode of stroke
  • Gait asymmetry before stimulation
  • Able to walk more than 100 meters with or without cane
  • Written informed consent

Exclusion Criteria:

  • Orthopaedic or rheumatologic disorders impeding the good realisation of the measurement
  • Adults under legal protective regimen or deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemiplegia after vascular stroke
  • Muscle vibration stimulation
  • Gait analysis with Gait Rite : quantitative and spatio-temporal gait parameters
  • Kinematic gait analysis in lower limb measured by optoelectronic system (Optitrack).
  • Analysis of static posture on force platform
  • Evaluation of the gait on treadmill during 2 minutes
Other: Gait analysis
Other Names:
  • Gait analysis system : Gait Rite®
Other: Kinematic gait analysis in lower limb
Other Names:
  • Optoelectronic system : Optitrack
Other: Analysis of static posture
Other Names:
  • Force platform Feetest® (Technoconcept, France)
Other: Gait on treadmill
Treadmill during 2 minutes
Device: Muscle vibration stimulation
Vibration stimulation at a 70 Hz frequency of biceps brachii muscle (sham), posterior neck muscles and gluteus medius muscle on the hemiplegic side
Other Names:
  • Device : VB 115 Vibrasens© (Technoconcept, France)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of monopodal stance on the hemiplegic side
Time Frame: Day 0
Improvement of the percentage of monopodal stance on the hemiplegic side during walking after stimulation by vibrations measured by quantitative gait analysis with Gait Rite
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatio-temporal gait parameters
Time Frame: Day 0
Spatio-temporal gait parameters : speed, step time, time of double stance, time of swing, length and width of step
Day 0
Kinematic gait parameters in lower limb
Time Frame: Day 0
Kinematic gait parameters in lower limb (hip, knee, ankle) measured by optoelectronic system (Optitrack).
Day 0
Static posture asymmetry
Time Frame: Day 0
Analysis of static posture on force platform
Day 0
Gait parameters on treadmill
Time Frame: Day 0
Evaluation of gait parameters during 2 minutes on treadmill, measured by optoelectronic system (Optitrack).
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

École Normale Supérieure de Cachan

Investigators

  • Principal Investigator: Isabelle Bonan, MD, PhD, CHU Rennes - Service de Médecine Physique et de Réadaptation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIBR-AVC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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