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Stroke's Gait Pattern Modifications of Induced by Repeated BTI

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ClinicalTrials.gov Identifier: NCT01973023
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805

Brief Summary:

Chronic stroke patients exhibit gait pattern alterations which are mainly due to spasticity and treated with repetitive multifocal botulinum toxin injection(BTI). Several studies demonstrated that single BTI-session in a single muscle of paretic lower limb(LL) improved kinematic gait parameters(GP) but surprisingly none of them assessed the effects of repetitive multifocal BTI on patient's gait pattern and their duration.

The aim was to evaluate the impact of repetitive multifocal BTI-sessions on GP of chronic stroke patients. To that end, gait of patients has been compared using 3D-gait analysis after at least 2 consecutive BTI sessions.


Condition or disease Intervention/treatment
Effect of Repeated Botulinum Toxin Injection on Gait Pattern in Stroke Patients Other: Motion analysis

Detailed Description:
All the patients will be tretaed with BTI . these injections will be performed under electrical stimulation control (~5mA). The dose, the number of site of injection per muscle is at the discretion of the physician according to patients' needs and physicians' routine clinical practice. The dilution the most commonly used will depend on the type of BoNT-A (BOTOX®, XEOMIN® or DYSPORT®) and was 100 U for 2.5ml (BOTOX® and XEOMIN®) or 500 U for 2.5 ml (Dysport®).

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Study Type : Observational
Actual Enrollment : 25 participants
Time Perspective: Retrospective
Official Title: Improvement of Chronic Stroke Patients Gait Pattern Following Repetitive Multifocal Botulinum Toxin Injection Sessions in Paretic Lower Limb: an Observational Study.
Study Start Date : July 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Group/Cohort Intervention/treatment
Chronic spastic stroke patients
Chronic spastic stroke patients treated regularly with botulinum toxin injection in lower limb muscles
Other: Motion analysis
Motion analysis was used to assess the modifications of gait pattern in chronic spastic stroke patients regularly treated with botulinum toxin injection




Primary Outcome Measures :
  1. kinematics gait parameters [ Time Frame: 3h ]
    peak knee flexion in swing phase(°)


Secondary Outcome Measures :
  1. spatiotemporal gait parmeters [ Time Frame: 3h ]
    gait velocity(m/s)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
STROKE PATIENTS
Criteria

Inclusion Criteria:

->18 years

  • a single hemispheric cerebral vascular lesion more than 6 months previously
  • able to walk 10 meters without any assistance
  • having benefited of at least 2 consecutive BTI sessions, second 3D gait analysis performed at least 3 months after the last BTI.

Exclusion Criteria:

  • patient's refusal to participate to the study
  • Inability to read the selected text
  • Inability to cooperate
  • No affiliation to social security

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973023


Locations
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France
Hopital Raymond Poincare
Garches, France, 92380
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
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Principal Investigator: ROCHE Nicolas, MDPHD HOPITAL RAYMOND POINCARE-GARCHES

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Responsible Party: Nicolas ROCHE, MDPHD, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01973023     History of Changes
Other Study ID Numbers: 1687472
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: March 2014

Keywords provided by Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805:
botulinum toxin injection
stroke
3D motion analysis
gait pattern

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs