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
Secondary identifying numbers RBF 96X23
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
22/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesIs 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) studiedNervous system diseases: Cerebral palsy
Intervention1. 24 ng Dysport/kg body weight
2. 8 ng Dysport/kg (using impairment measures)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Botulinum toxin (Dysport)
Primary outcome measure1. 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
Secondary outcome measuresSecondary outcome variable was maximum ankle angle measured during stance and swing phases.
Overall study start date01/03/1997
Completion date31/07/2000

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants60
Key inclusion criteriaChildren with hemiplegic cerebral palsy
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/03/1997
Date of final enrolment31/07/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Trent (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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