Comparison of low dose versus high dose Botulinum toxin (Dysport) in the treatment of children with hemiplegic cerebral palsy.

ISRCTN	ISRCTN37525568
DOI	https://doi.org/10.1186/ISRCTN37525568
Protocol serial number	RBF 96X23
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Trent (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Chris Ward
Scientific

Southern Derbyshire Acute Hospitals NHS Trust
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Phone	+44 (0)1332 340141 Ext 5680
Email	c.d.ward@nottingham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is 24 ng Dysport/Kg body weight more efficacious than 8 ng Dysport/Kg (using impairment measures)
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nervous system diseases: Cerebral palsy
Intervention	1. 24 ng Dysport/kg body weight 2. 8 ng Dysport/kg (using impairment measures)
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Botulinum toxin (Dysport)
Primary outcome measure(s)	1. Impairment measure using gait analysis 2. Gastrocnemius muscle length was calculated at each visit using the method described by Eames and used as primary outcome measure
Key secondary outcome measure(s)	Secondary outcome variable was maximum ankle angle measured during stance and swing phases.
Completion date	31/07/2000

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	60
Key inclusion criteria	Children with hemiplegic cerebral palsy
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/03/1997
Date of final enrolment	31/07/2000

Southern Derbyshire Acute Hospitals NHS Trust

Derby
DE22 3NE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/08/2002		Yes	No