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

• Conditions: Botulinum Toxins Injection in Stroke Patients
• Interventions: Other: Motion Analysis

• Registration Number: NCT02699775
• 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 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®)

Study Timeline

• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-04
• Study Start: 2017-12-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Arm && Interventions

Group	Intervention	Description
Chronic spastic stroke patients	Motion Analysis	Chronic spastic stroke patients treated regularly with botulinum toxin injection in lower limb muscles

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Raymond Poincaré hospital; 🇫🇷 Garches, France