Effect of botulinum toxin treatment in children with cerebral palsy

ISRCTN	ISRCTN35169306
DOI	https://doi.org/10.1186/ISRCTN35169306
Secondary identifying numbers	Stichting Bio-Kinderrevalidatie (PGO 01-0134); NTR41

Submission date: 04/08/2005
Registration date: 04/08/2005
Last edited: 11/06/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof J.G. Becher
Scientific

P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 0763
Email	reva@vumc.nl

Study information

Study design	Multicentre, randomised active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	The effect of multi-level botulinum toxin treatment and intensive rehabilitation on walking ability in children with cerebral palsy
Study acronym	The BOLIEN project
Study objectives	Multi-level botulinum toxin-A (BTX-A) treatment of the lower extremities in combination with comprehensive rehabilitation leads to an improvement in mobility of children with cerebral palsy.
Ethics approval(s)	Ethics approval received from the local ethics committee.
Health condition(s) or problem(s) studied	Cerebral parese (cerebral palsy)
Intervention	Group A: multi-level BTX injections 6 weeks after the first assessment Group B: multi-level BTX injections 30 weeks after the first assessment Intervention: Multi-level treatment with botulinum toxin A (BTX). Possible target muscles for a multi-level treatment are the psoas, medial/lateral hamstrings, hip-adductors, rectus femoris, triceps surae, and tibialis anterior/posterior unilateral or bilateral. Starting one week after the multi-level BTX-injections, the patients will be treated by a physiotherapist according to a standardised treatment protocol for 12 weeks. Randomisation: The patients will be randomised into two groups in a multiple baseline design. Follow-up measurements will be performed at 6, 12, 24 and 48 weeks.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Botulinum toxin
Primary outcome measure	1. Gross Motor Function Measure (GMFM) 2. Energy cost of walking
Secondary outcome measures	1. Spasticity of the treated muscles 2. Passive range of motion of lower extremity joints 3. Edinburgh Visual Gait score (GAIT) 4. Paediatric Evaluation Disability Inventory (PEDI), domain mobility 5. Problem score
Overall study start date	01/02/2001
Completion date	01/08/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	47
Key inclusion criteria	1. Diagnosis of cerebral palsy (CP), hemiplegia or diplegia 2. Ability to walk with or without a walking aid, with or without an ankle-foot orthosis 2. Gait characterised by persistent flexion of the hip and knee in mid-stance when walking 3. Aged between 4 and 12 years
Key exclusion criteria	1. BTX treatment in lower extremities 16 weeks before inclusion 2. Orthopaedic surgery 24 weeks before inclusion 3. Contra-indication for BTX-A 4. Contra-indication for general anaesthesia 5. Severe fixed contractures 6. Orthopaedic deformities, which have a bad influence on walking: 6.1. (Sub)luxation of the hip with a migration index greater than 50 degrees 6.2. Hip endorotation contracture greater than 15 degrees 6.3. Flexion contracture of knee greater than 15 degrees 7. Presence of ataxia of dyskinesia 8. Other problems which have a negative influence on walking
Date of first enrolment	01/02/2001
Date of final enrolment	01/08/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

P.O. Box 7057

Amsterdam
1007 MB
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
University/education

Faculty of Earth and Life Sciences
Institute of Health Sciences
De Boelelaan 1085
Amsterdam
1081 HV
Netherlands

Website	http://www.vumc.nl/english/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Charity

Princess Beatrix Funds (Prinses Beatrix Fonds) (The Netherlands)

No information available

Johanna Kinderfonds (The Netherlands)

No information available

Foundation for Paediatric Rehabilitation (Stichting Bio-Kinderrevalidatie) (The Netherlands)

No information available

Results and Publications

Intention to publish date
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