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

C

Centre d'Investigation Clinique et Technologique 805

Status

Unknown

Conditions

Botulinum Toxins Injection in Stroke Patients

Treatments

Other: Motion Analysis

Study type

Observational

Funder types

Other

Identifiers

NCT02699775
2015-A01671-48

Details and patient eligibility

About

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.

Full 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®)

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

30 participants in 1 patient group

Chronic spastic stroke patients
Description:
Chronic spastic stroke patients treated regularly with botulinum toxin injection in lower limb muscles
Treatment:
Other: Motion Analysis

Trial contacts and locations

1

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Central trial contact

Nicolas ROCHE, MD PhD

Data sourced from clinicaltrials.gov

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