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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02096367
Acronym
VIBR-AVC
Enrollment
21
Registered
2014-03-26
Start date
2014-04-30
Completion date
2015-04-30
Last updated
2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia, Stroke

Keywords

vibrations, stroke, posture, gait, readaptation

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.

Interventions

OTHERGait analysis
OTHERKinematic gait analysis in lower limb
OTHERAnalysis of static posture
OTHERGait on treadmill

Treadmill during 2 minutes

DEVICEMuscle 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

Sponsors

École Normale Supérieure de Cachan
CollaboratorOTHER
Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of monopodal stance on the hemiplegic sideDay 0Improvement 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

MeasureTime frameDescription
Spatio-temporal gait parametersDay 0Spatio-temporal gait parameters : speed, step time, time of double stance, time of swing, length and width of step
Kinematic gait parameters in lower limbDay 0Kinematic gait parameters in lower limb (hip, knee, ankle) measured by optoelectronic system (Optitrack).
Static posture asymmetryDay 0Analysis of static posture on force platform
Gait parameters on treadmillDay 0Evaluation of gait parameters during 2 minutes on treadmill, measured by optoelectronic system (Optitrack).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026