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Clinical Trials/NCT02096367
NCT02096367
Completed
Not Applicable

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

Rennes University Hospital1 site in 1 country21 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
Rennes University Hospital
Enrollment
21
Locations
1
Primary Endpoint
Percentage of monopodal stance on the hemiplegic side
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Gait parameters on treadmill(Day 0)
  • Static posture asymmetry(Day 0)
  • Spatio-temporal gait parameters(Day 0)
  • Kinematic gait parameters in lower limb(Day 0)

Study Sites (1)

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