Stroke's Gait Pattern Modifications of Induced by Repeated BTI

Completed

• Conditions: Effect of Repeated Botulinum Toxin Injection on Gait Pattern in Stroke Patients

• Registration Number: NCT01973023
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-07
• Primary Completion: 2013-10
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
kinematics gait parameters	3h	peak knee flexion in swing phase(°)

Secondary Outcome Measures

Name	Time	Method
spatiotemporal gait parmeters	3h	gait velocity(m/s)

Trial Locations

Locations (1)

Hopital Raymond Poincare; 🇫🇷 Garches, France