Condition category
Nervous System Diseases
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
11/06/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.vumc.nl/revalidatie/onderzoek

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

http://www.vumc.nl/english/

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

Publication citations

Additional files

Editorial Notes