Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia (NCT03938363) | Clinical Trial Compass
CompletedNot Applicable
Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia
France40 participantsStarted 2019-10-23
Plain-language summary
Efficient gait requires effective postural control, both static and dynamic. Hence, postural disorders may affect gait. Yet, very little is known about the specific effects of focal postural disorders such as cervical dystonia (CD) and blepharospasm (BS) on patients' mobility.
The present research therefore aims at analyzing gait characteristics in patients presenting with these conditions in order to document possible gait alterations.
In addition, the investigators will explore the effect of botulinum toxin treatment, which the most frequently used therapeutic option, on the patients' gait characteristics. Indeed, while the treatment improves both dystonia and pain, and therefore quality of life, its influence on gait is presently unknown. the investigators aim at filling this knowledge gap
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* speaking French, in the ability to understand clinical tests and explorations,
* in ability to move to the CHU Grenoble Alpes
* Diagnosis of cervical dystonia or isolated Blepharospasm,
* Absence of neurological or psychiatric disorders,
* Affiliation to a health insurance,
* Signed consent fo the subject.
Exclusion Criteria:
* Pregnant women (positive pregnancy test), parturient or breastfeeding
* Cervical dystonia or Blepharospasm of secondary origin
* subjects having benefited from deep brain stimulation,
* History of other pathologies that may lead to walking disorders, inability to walk without technical assistance, inability to walk for more than 10 minutes,
* Subjects receiving botulinum toxin treatment for another cause.
Prohibited treatments and procedures:
* Antecedent of pathologies that may cause walking disorders
* Simultaneous participation in another Interventional study
* Subject in time of exclusion from another study
* Subject under guardianship or having curators (major protected)
* Subject under administrative or judicial supervision
* Subject not able to be contacted in case of emergency
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.