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

NCT ID: NCT02096367

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Hemiplegia; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemiplegia after vascular stroke

• 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

Group Type: EXPERIMENTAL

Gait analysis

Intervention Type: OTHER

Kinematic gait analysis in lower limb

Intervention Type: OTHER

Analysis of static posture

Intervention Type: OTHER

Gait on treadmill

Intervention Type: OTHER

Treadmill during 2 minutes

Muscle vibration stimulation

Intervention Type: DEVICE

Vibration stimulation at a 70 Hz frequency of biceps brachii muscle (sham), posterior neck muscles and gluteus medius muscle on the hemiplegic side

Interventions

Gait analysis

Intervention Type: OTHER

Kinematic gait analysis in lower limb

Intervention Type: OTHER

Analysis of static posture

Intervention Type: OTHER

Gait on treadmill

Treadmill during 2 minutes

Intervention Type: OTHER

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

Intervention Type: DEVICE

Other Intervention Names

Gait analysis system : Gait Rite®; Optoelectronic system : Optitrack; Force platform Feetest® (Technoconcept, France); Device : VB 115 Vibrasens© (Technoconcept, France)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

École Normale Supérieure de Cachan

OTHER

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Bonan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes - Service de Médecine Physique et de Réadaptation

Locations

CHU Rennes - Pontchaillou Hospital

Rennes, Brittany Region, France

Countries

France

Other Identifiers

VIBR-AVC

Identifier Type: -

Identifier Source: org_study_id