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Clinical Trials/NCT01973023
NCT01973023
Completed
Not Applicable

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

Centre d'Investigation Clinique et Technologique 8051 site in 1 country25 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Effect of Repeated Botulinum Toxin Injection on Gait Pattern in Stroke Patients
Sponsor
Centre d'Investigation Clinique et Technologique 805
Enrollment
25
Locations
1
Primary Endpoint
kinematics gait parameters
Status
Completed
Last Updated
10 years ago

Overview

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.

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®).

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
January 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre d'Investigation Clinique et Technologique 805
Responsible Party
Principal Investigator
Principal Investigator

Nicolas ROCHE

MDPHD

Centre d'Investigation Clinique et Technologique 805

Eligibility 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

Outcomes

Primary Outcomes

kinematics gait parameters

Time Frame: 3h

peak knee flexion in swing phase(°)

Secondary Outcomes

  • spatiotemporal gait parmeters(3h)

Study Sites (1)

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