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

Not Applicable

Completed

• Conditions: Stroke; Hemiplegia
• Interventions: Other: Gait analysis; Other: Kinematic gait analysis in lower limb; Other: Analysis of static posture; Other: Gait on treadmill; Device: Muscle vibration stimulation

• Registration Number: NCT02096367
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Study Start: 2014-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemiplegia after vascular stroke	Analysis of static posture	* 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
Hemiplegia after vascular stroke	Gait analysis	* 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
Hemiplegia after vascular stroke	Kinematic gait analysis in lower limb	* 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
Hemiplegia after vascular stroke	Gait on treadmill	* 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
Hemiplegia after vascular stroke	Muscle vibration stimulation	* 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

Primary Outcome Measures

Name	Time	Method
Percentage of monopodal stance on the hemiplegic side	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 Outcome Measures

Name	Time	Method
Gait parameters on treadmill	Day 0	Evaluation of gait parameters during 2 minutes on treadmill, measured by optoelectronic system (Optitrack).
Static posture asymmetry	Day 0	Analysis of static posture on force platform
Spatio-temporal gait parameters	Day 0	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	Day 0	Kinematic gait parameters in lower limb (hip, knee, ankle) measured by optoelectronic system (Optitrack).

Trial Locations

Locations (1)

CHU Rennes - Pontchaillou Hospital; 🇫🇷 Rennes, Brittany, France