Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Integrated Management of Pronation Deformity in CP with BoNT-A
NCT03472261Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2018
- Primary completion
- Mar 2020
- Countries
- 1
- Sponsor
- Kocaeli University
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- cerebral palsy (CP)
01
Overview
Phase 3, randomised, single-blind trial of botulinum toxin type A in cerebral palsy (CP) (2 arms), sponsored by Kocaeli University. Primary endpoint: Modified Ashworth Scale at 12 weeks. Started Mar 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Experimental Group
Dysport + Twister + Home Exercise
Conventional Therapy Group
Dysport + Home Exercise
03
Who it enrols
Children with cerebral palsy, MAS score of pronator muscles at least 2, GMFCS level I-IV, scheduled for BoNT injections. Excludes severe cognitive/behavioral problems, severe dystonia, or prior orthopedic surgery.
04
Endpoints
Primary
Modified Ashworth Scale
Secondary
Passive Range of Supination
Tardieu Scale (Angle of Catch XV3)
Active Range of Supination
Beyond the preview
Go deeper on NCT03472261.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03472261.