Stroke's Gait Pattern Modifications of Induced by Repeated BTI
Improvement of Chronic Stroke Patients Gait Pattern Following Repetitive Multifocal Botulinum Toxin Injection Sessions in Paretic Lower Limb: an Observational Study.
1 other identifier
observational
25
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 has been compared using 3D-gait analysis after at least 2 consecutive 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 Jul 2013
Shorter than P25 for all trials
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
Study Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 9, 2013
CompletedFirst Posted
Study publicly available on registry
October 31, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMarch 2, 2016
March 1, 2014
3 months
October 9, 2013
March 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
kinematics gait parameters
peak knee flexion in swing phase(°)
3h
Secondary Outcomes (1)
spatiotemporal gait parmeters
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 was 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)
Hopital Raymond Poincare
Garches, Garches, 92380, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ROCHE Nicolas, MDPHD
HOPITAL RAYMOND POINCARE-GARCHES
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MDPHD
Study Record Dates
First Submitted
October 9, 2013
First Posted
October 31, 2013
Study Start
July 1, 2013
Primary Completion
October 1, 2013
Study Completion
January 1, 2014
Last Updated
March 2, 2016
Record last verified: 2014-03