Valuation of the Evolution of Passive Mobility in the Spastic Upper Limb After Injection of Abobotulinumtoxin(Dysport®)
NCT ID: NCT05151874
Last Updated: 2021-12-09
Study Results
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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UNKNOWN
12 participants
OBSERVATIONAL
2022-01-31
2022-12-31
Brief Summary
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Detailed Description
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The spasticity pattern that will be evaluated will be pattern number III based on the classification of Jost et al. Joint mobility will be measured with the Lynx instrument (DyCare)
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Range of movement
Change in passive joint mobility (ROM) of the carpus (flexion-extension) affected by spasticity pattern III during a 20-week follow-up.
Abobotulinum toxin A
To measure ROM evolution in patients with post-stroke spasticity in the upper limb with spasticity pattern III.
Interventions
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Abobotulinum toxin A
To measure ROM evolution in patients with post-stroke spasticity in the upper limb with spasticity pattern III.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hemiplegic patients with post-stroke upper limb spasticity affected by pattern III1 who have undergone at least 2 cycles of previous treatment with BoNT-A
* Patients with a MAS scale (Modified Ashworth Scale) between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
* Patients with Hackett ultrasound qualitative scale between 2 and 3 for the affected muscle group; shoulder, elbow, carpus and metacarpophalangeal.
Exclusion Criteria
* Prior lack of primary or secondary response to any BoNT-A for any specific condition or known sensitivity to BoNT-A or any excipient.
* Routine or prescribed treatment with any medication that directly or indirectly interferes with neuromuscular function in the last 3 months prior to study botulinum toxin treatment.
* Having undergone surgery on the muscles, ligaments, tendons, nerves or bones of the limb to be treated.
* Any medical condition or analytical finding that, in the opinion of the investigator, may compromise compliance with the objectives and / or procedures of the study protocol or exclude the administration of BoNT-A.
* Treatment with an investigational new drug in the 4 weeks or 5 half-lives prior to screening to enter the study.
* Pregnancy.
18 Years
99 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Facility Contacts
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Helena Bascuñana, Dr
Role: primary
Eliot Ramirez, Dr
Role: backup
Other Identifiers
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IIBSP-ROM-2020-135
Identifier Type: -
Identifier Source: org_study_id