Stroke's Gait Pattern Modifications of Induced by Repeated BTI

NCT ID: NCT01973023

Last Updated: 2016-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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®).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chronic spastic stroke patients

Chronic spastic stroke patients treated regularly with botulinum toxin injection in lower limb muscles

Motion analysis

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Motion analysis

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nicolas ROCHE

MDPHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ROCHE Nicolas, MDPHD

Role: PRINCIPAL_INVESTIGATOR

HOPITAL RAYMOND POINCARE-GARCHES

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hopital Raymond Poincare

Garches, Garches, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1687472

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gait Recovery After Stroke
NCT06806748 NOT_YET_RECRUITING
Robotic Exoskeleton Assisted Gait Post Stroke
NCT04309305 ENROLLING_BY_INVITATION PHASE1