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Clinical Trials/NCT02699775
NCT02699775
Unknown
Not Applicable

Effect of 3 Consecutives Botulinum Toxin Injection on Gait Pattern in Stroke Patients

Centre d'Investigation Clinique et Technologique 8051 site in 1 country30 target enrollmentDecember 12, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Botulinum Toxins Injection in Stroke Patients
Sponsor
Centre d'Investigation Clinique et Technologique 805
Enrollment
30
Locations
1
Primary Endpoint
kinematics gait parameters
Last Updated
8 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 will be compared using 3D-gait analysis after 3 consecutives BTI sessions.

Detailed Description

All the patients will be treated 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 be 100 U for 2.5ml (XEOMIN®)

Registry
clinicaltrials.gov
Start Date
December 12, 2017
End Date
December 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

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

Nicolas ROCHE

MD PhD

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 parameters(3h)

Study Sites (1)

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