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

Stroke Clinical Trial

— VIBR-AVC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096367
• Other study ID #: VIBR-AVC
• Status: Completed
• Phase: N/A
• First received: March 12, 2014
• Last updated: June 8, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Other:
• Gait analysis

• Kinematic gait analysis in lower limb

• Analysis of static posture

• 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

Locations

Country	Name	City	State
France	CHU Rennes - Pontchaillou Hospital	Rennes	Brittany

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	École Normale Supérieure de Cachan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0	No
Secondary	Spatio-temporal gait parameters	Spatio-temporal gait parameters : speed, step time, time of double stance, time of swing, length and width of step	Day 0	No
Secondary	Kinematic gait parameters in lower limb	Kinematic gait parameters in lower limb (hip, knee, ankle) measured by optoelectronic system (Optitrack).	Day 0	No
Secondary	Static posture asymmetry	Analysis of static posture on force platform	Day 0	No
Secondary	Gait parameters on treadmill	Evaluation of gait parameters during 2 minutes on treadmill, measured by optoelectronic system (Optitrack).	Day 0	No