Stroke's Gait Pattern Modifications of Induced by Repeated BTI

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

Official title:

Improvement of Chronic Stroke Patients Gait Pattern Following Repetitive Multifocal Botulinum Toxin Injection Sessions in Paretic Lower Limb: an Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973023
• Other study ID #: 1687472
• Status: Completed
• Phase: N/A
• First received: October 9, 2013
• Last updated: March 1, 2016
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• 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 has been compared using 3D-gait analysis after at least 2 consecutive BTI sessions.

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Intervention

Other:
• Motion analysis
Motion analysis was 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	Hopital Raymond Poincare	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

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	No
Secondary	spatiotemporal gait parmeters	gait velocity(m/s)	3h	No