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

NCT ID: NCT02699775

Last Updated: 2018-01-25

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

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-12

Study Completion Date

2019-12-31

Brief Summary

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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

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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®)

Conditions

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Botulinum Toxins Injection in Stroke Patients

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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

Interventions

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Motion Analysis

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

Intervention Type OTHER

Eligibility Criteria

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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

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Fondation Garches

OTHER

Sponsor Role collaborator

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

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Nicolas ROCHE

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolas ROCHE, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Raymond Poincare Hospital

Locations

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Raymond Poincaré hospital

Garches, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nicolas ROCHE, MD PhD

Role: CONTACT

0033147105409

Facility Contacts

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Nicolas ROCHE, Md, PhD

Role: primary

0033147105409

Other Identifiers

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2015-A01671-48

Identifier Type: -

Identifier Source: org_study_id

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