Actively Recruiting
Upper-limb Active Function and Botulinum Toxin a
Led by University Hospital, Toulouse · Updated on 2024-10-23
80
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study in an observational, prospective and longitudinal study. The aim of the study is to evaluate the effect of botulinum toxin type A (BTX) injections into the elbow flexors on the reduction of spastic co-contractions (spastic co-contraction index, SCCI) during an active elbow extension in chronic post-stroke patients.TBA injections are performed as part of routine care
CONDITIONS
Official Title
Upper-limb Active Function and Botulinum Toxin a
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cortical and/or subcortical ischemic or haemorrhagic stroke for at least 6 months
- Indication for botulinum toxin A injection in elbow flexor muscles based on clinical criteria aiming to improve elbow extension function or appearance
- Currently prescribed abobotulinum toxin A (DYSPORT����)
- Ability to actively extend the elbow more than 20 degrees
- Active elbow extension limited by more than 15 degrees or a 50% decrease in active elbow extension rate
- Never treated with botulinum toxin or only one prior injection targeting elbow flexors more than 4 months ago
- Age over 18 years
- Signed informed consent
- Affiliated with social security coverage
You will not qualify if you...
- Passive limitation of elbow extension greater than 30 degrees
- Pain during active elbow flexion or extension movements
- Cognitive disorder limiting understanding of basic instructions
- Progressive or unstable neurological disease
- Uncontrolled epilepsy
- Anticoagulant treatment at curative dose or bleeding disorders contraindicating intramuscular injections
- Claustrophobia or metallic implants preventing MRI
- General contraindications to botulinum toxin such as hypersensitivity, swallowing disorders, chronic respiratory issues, history of myasthenia or Lambert-Eaton syndrome, neuromuscular disease, recent surgery with curarization, or current treatment with certain drugs
- Skin infection or inflammation at injection site
- Legal incapacity
- Pregnant or breastfeeding women
- Women desiring pregnancy within 18 months
- Non-menopausal women not using highly effective contraception methods
- For control group: history of orthopedic or neurological disorders, intensive upper limb sports competition experience, or legal incapacity
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Toulouse
Toulouse, France, 31059
Actively Recruiting
Research Team
D
David Gasq, MD
CONTACT
A
Audrey Tomasik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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