Comparison of low dose versus high dose Botulinum toxin (Dysport) in the treatment of children with hemiplegic cerebral palsy.
ISRCTN | ISRCTN37525568 |
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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
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 |
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c.d.ward@nottingham.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Botulinum toxin (Dysport) |
Primary outcome measure | 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 |
Secondary outcome measures | Secondary outcome variable was maximum ankle angle measured during stance and swing phases. |
Overall study start date | 01/03/1997 |
Completion date | 31/07/2000 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |