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

Botulinum Toxins Injection in Stroke Patients Clinical Trial

— TRITITOX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02699775
• Other study ID #: 2015-A01671-48
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2016
• Last updated: January 23, 2018
• Start date: December 12, 2017
• Est. completion date: December 2019

Study information

• Verified date: January 2018
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: Nicolas ROCHE, MD PhD
• Phone: 0033147105409
• Email: roche.nicolas[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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®)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Botulinum Toxins Injection in Stroke Patients
• Stroke

Intervention

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

Locations

Country	Name	City	State
France	Raymond Poincaré hospital	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805	Fondation Garches

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kinematics gait parameters	peak knee flexion in swing phase(°)	3h
Secondary	spatiotemporal gait parameters	Gait velocity (m/s)	3h