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

NCT02096367 | Completed

• 1 other identifier: VIBR-AVC
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Stroke

Keywords

vibrations; stroke; posture; gait; readaptation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Spatio-temporal gait parameters

  Day 0

• Kinematic gait parameters in lower limb

  Day 0

• Static posture asymmetry

  Day 0

• Gait parameters on treadmill

  Day 0

Study Arms (1)

Hemiplegia after vascular stroke

EXPERIMENTAL

* 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

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

Interventions

Gait analysis OTHER

Also known as: Gait analysis system : Gait Rite®

Hemiplegia after vascular stroke

Kinematic gait analysis in lower limb OTHER

Also known as: Optoelectronic system : Optitrack

Hemiplegia after vascular stroke

Analysis of static posture OTHER

Also known as: Force platform Feetest® (Technoconcept, France)

Hemiplegia after vascular stroke

Gait on treadmill OTHER

Treadmill during 2 minutes

Hemiplegia after vascular stroke

Muscle vibration stimulation DEVICE

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

Also known as: Device : VB 115 Vibrasens© (Technoconcept, France)

Hemiplegia after vascular stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Orthopaedic or rheumatologic disorders impeding the good realisation of the measurement
• Adults under legal protective regimen or deprived of liberty

Sponsors & Collaborators

• Rennes University Hospital: lead
• École Normale Supérieure de Cachan: collaborator

Study Sites (1)

CHU Rennes - Pontchaillou Hospital

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

Hemiplegia; Stroke

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Isabelle Bonan, MD, PhD

  CHU Rennes - Service de Médecine Physique et de Réadaptation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 26, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 9, 2015

Record last verified: 2015-06

Locations

FR (1)