Effect of Repeated Botulinum Toxin Injection on Gait Pattern in Stroke Patients
TRITITOX
Effect of 3 Consecutives Botulinum Toxin Injection on Gait Pattern in Stroke Patients
1 other identifier
observational
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedStudy Start
First participant enrolled
December 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 25, 2018
January 1, 2018
1.8 years
March 1, 2016
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
kinematics gait parameters
peak knee flexion in swing phase(°)
3h
Secondary Outcomes (1)
spatiotemporal gait parameters
3h
Study Arms (1)
Chronic spastic stroke patients
Chronic spastic stroke patients treated regularly with botulinum toxin injection in lower limb muscles
Interventions
Motion analysis is used to assess the modifications of gait pattern in chronic spastic stroke patients regularly treated with botulinum toxin injection
Eligibility Criteria
STROKE PATIENTS
You may qualify if:
- \>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.
You may not qualify if:
- patient's refusal to participate to the study
- Inability to read the selected text
- Inability to cooperate
- No affiliation to social security
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Raymond Poincaré hospital
Garches, 92210, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas ROCHE, MD PhD
Raymond Poincare Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
March 1, 2016
First Posted
March 4, 2016
Study Start
December 12, 2017
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
January 25, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share