Comparison of the therapeutic benefit to combination therapy of botulinum neurotoxin and cast as well as single dose of botulinum neurotoxin on the wrist spasticity in different time intervals
- Conditions
- G81.1I63.9Spastic hemiplegiaCerebral infarction, unspecified
- Registration Number
- DRKS00010413
- Lead Sponsor
- eurologisches Rehabilitationszentrum Leipzig
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Aged 18 years - stoke with spasticity of the upper limb -MAS 2 - 3 - noticeable catch (according to Tardieu Scale) -pROM wrist affected: = 0 ° in extension
- Age <18 years - MAS = 1+ or> 3 - wrist is not up to the 0 position (PROM) mobilized - no meaningful catch (Tardieu Scale) - fixed contracture of the fingers and / or wrist - Serious additional diseases - severe communication disorder - myasthenia gravis, Lambert-Eaton syndrome, ALS or other serious neuromuscular diseases - severe dysphagia - current administration of aminoglycosides - proven hypersensitivity to Clostridium botulinum toxin A or any of the excipients of the preparation Dysport® - Planned operations within the next 12 weeks ago - pregnancy, lactation period - anticoagulant therapy (Warfarin, Falithrom) - infections in the injection area and skin damage in the area of ??castings - Significant edematous swelling of the arm and hand - Peri-articular heterotrophic ossification in the investigation area - Unstable fractures in the study area - gout and diseases of rheumatic at the involved joints (upper limb)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method modified ashworth scale (MAS) modified tardieu scale
- Secondary Outcome Measures
Name Time Method - Active and passive range of motion (ROM or PROM)<br>- dorsiflexion force<br>- grip strength<br>- Wolf Motor Function Test (WMFT), optional ARAT