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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02699775

Acronym

TRITITOX

Enrollment

Registered

2016-03-04

Start date

2017-12-12

Completion date

2019-12-31

Last updated

2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Botulinum Toxins Injection in Stroke Patients

Keywords

Botulinum toxin injections, Stroke, 3D motion analysis, Gait pattern

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®)

Interventions

OTHERMotion Analysis

Motion analysis is used to assess the modifications of gait pattern in chronic spastic stroke patients regularly treated with botulinum toxin injection

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
spatiotemporal gait parameters	3h	Gait velocity (m/s)

Countries

France

Contacts

Primary ContactNicolas ROCHE, MD PhD

roche.nicolas@aphp.fr0033147105409

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026