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

Primary Purpose

Hemiplegia, Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Gait analysis
Kinematic gait analysis in lower limb
Analysis of static posture
Gait on treadmill
Muscle vibration stimulation
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring vibrations, stroke, posture, gait, readaptation

Eligibility Criteria

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

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

Sites / Locations

  • CHU Rennes - Pontchaillou Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hemiplegia after vascular stroke

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of monopodal stance on the hemiplegic side
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

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2014
Last Updated
June 8, 2015
Sponsor
Rennes University Hospital
Collaborators
École Normale Supérieure de Cachan
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1. Study Identification

Unique Protocol Identification Number
NCT02096367
Brief Title
Immediate Effect of Postural Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia
Acronym
VIBR-AVC
Official Title
Immediate Effect of Cervical Posterior Muscles' and Gluteus Medius Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
École Normale Supérieure de Cachan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Stroke
Keywords
vibrations, stroke, posture, gait, readaptation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemiplegia after vascular stroke
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Gait analysis
Other Intervention Name(s)
Gait analysis system : Gait Rite®
Intervention Type
Other
Intervention Name(s)
Kinematic gait analysis in lower limb
Other Intervention Name(s)
Optoelectronic system : Optitrack
Intervention Type
Other
Intervention Name(s)
Analysis of static posture
Other Intervention Name(s)
Force platform Feetest® (Technoconcept, France)
Intervention Type
Other
Intervention Name(s)
Gait on treadmill
Intervention Description
Treadmill during 2 minutes
Intervention Type
Device
Intervention Name(s)
Muscle vibration stimulation
Other Intervention Name(s)
Device : VB 115 Vibrasens© (Technoconcept, France)
Intervention Description
Vibration stimulation at a 70 Hz frequency of biceps brachii muscle (sham), posterior neck muscles and gluteus medius muscle on the hemiplegic side
Primary Outcome Measure Information:
Title
Percentage of monopodal stance on the hemiplegic side
Description
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
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Spatio-temporal gait parameters
Description
Spatio-temporal gait parameters : speed, step time, time of double stance, time of swing, length and width of step
Time Frame
Day 0
Title
Kinematic gait parameters in lower limb
Description
Kinematic gait parameters in lower limb (hip, knee, ankle) measured by optoelectronic system (Optitrack).
Time Frame
Day 0
Title
Static posture asymmetry
Description
Analysis of static posture on force platform
Time Frame
Day 0
Title
Gait parameters on treadmill
Description
Evaluation of gait parameters during 2 minutes on treadmill, measured by optoelectronic system (Optitrack).
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Bonan, MD, PhD
Organizational Affiliation
CHU Rennes - Service de Médecine Physique et de Réadaptation
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes - Pontchaillou Hospital
City
Rennes
State/Province
Brittany
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

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Immediate Effect of Postural Muscle's Vibrations on Gait in Chronic Vascular Hemiplegia

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