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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010413
Enrollment
60
Registered
2016-06-07
Start date
2010-04-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G81.1 I63.9

Interventions

Group 1: - Casting for 14 days - BoNT injection on day 14 (at time of 0) Group 2: - Simultaneous casting and injection of BoNT at the time of 0 Group 3: - BoNT injection at time of 0 - 14 days later (

Sponsors

Neurologisches Rehabilitationszentrum Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: - Age 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)

Design outcomes

Primary

MeasureTime frame
modified ashworth scale (MAS) modified tardieu scale

Secondary

MeasureTime frame
- Active and passive range of motion (ROM or PROM) - dorsiflexion force - grip strength - Wolf Motor Function Test (WMFT), optional ARAT

Countries

Germany

Contacts

Public ContactHartwig Woldag

Neurologisches Rehabilitationszentrum Leipzig

woldag@sachsenklinik.de(03425) 888-196

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026