Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof J.G. Becher
ORCID ID
Contact details
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 0763
reva@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Stichting Bio-Kinderrevalidatie (PGO 01-0134); NTR41
Study information
Scientific title
The effect of multi-level botulinum toxin treatment and intensive rehabilitation on walking ability in children with cerebral palsy
Acronym
The BOLIEN project
Study hypothesis
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
Ethics approval received from the local ethics committee.
Study design
Multicentre, randomised active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Botulinum toxin
Primary outcome measures
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 trial start date
01/02/2001
Overall trial end date
01/08/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
47
Participant 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
Recruitment start date
01/02/2001
Recruitment end date
01/08/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Faculty of Earth and Life Sciences
Institute of Health Sciences
De Boelelaan 1085
Amsterdam
1081 HV
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Princess Beatrix Funds (Prinses Beatrix Fonds) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Johanna Kinderfonds (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation for Paediatric Rehabilitation (Stichting Bio-Kinderrevalidatie) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary