Stroke's Gait Pattern Modifications of Induced by Repeated BTI

March 1, 2016 updated by: Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805

Improvement of Chronic Stroke Patients Gait Pattern Following Repetitive Multifocal Botulinum Toxin Injection Sessions in Paretic Lower Limb: an Observational Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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®).

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Garches, France, 92380
        • Hopital Raymond Poincare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

STROKE PATIENTS

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
kinematics gait parameters
Time Frame: 3h
peak knee flexion in swing phase(°)
3h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spatiotemporal gait parmeters
Time Frame: 3h
gait velocity(m/s)
3h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Investigators

  • Principal Investigator: ROCHE Nicolas, MDPHD, HOPITAL RAYMOND POINCARE-GARCHES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (ESTIMATE)

October 31, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1687472

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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