Condition category
Nervous System Diseases
Date applied
04/12/2007
Date assigned
31/03/2008
Last edited
20/08/2015
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.srl.nl/default.asp?id=396&parent=0&template=algemeen.htm&sitecat=5

Contact information

Type

Scientific

Primary contact

Mrs Lucianne Speth

ORCID ID

Contact details

Franciscusoord Child Rehabilitation
Onderstestraat 29
Valkenburg
6301 KA
Netherlands
+31 (0)455 282 615
LSpeth@T-Online.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL12005.096.06

Study information

Scientific title

Effect of botulinum toxin A injections and specific intensive rehabilitation therapy in children with hemiparetic cerebral palsy on upper limb functions and skills

Acronym

BoBiVa (Botuline toxine Bimanuele Vaardigheden)

Study hypothesis

Research question:
What is the effect of botulinum toxin A (btA) injections (B), an intensive physical and occupational therapy program aimed at improving arm function and skills (C), or a combination of both (A), on arm function, bimanual skills and use of the affected arm, in children with hemiparetic cerebral palsy, relative to the course in such children who receive usual care (D)?

Ethics approval

1. Medical Ethics Committee of the Meuse Hospital (Medisch Ethische Toetsingscommissie Atrium MC-Maaslandziekenhuis), 27/07/2006
2. This trial is also registered at the Centrale Commissie Mensgebonden Onderzoek (CCMO) Central Committee for Research Involving Human Subjects (https://toetsingonline.ccmo.nl) (ref: NL12005.096.06)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cerebral palsy

Intervention

This study will take place in three hospitals in the Netherlands: University Hospital Maastricht (Franciscusoord Valkenburg), Maartenskliniek Nijmegen Hospital and Free University Medical Centre (Vrije Universiteit Medisch Centrum [VUMC]) Amsterdam.

Interventions:
Group A: BtA injections (Dysport®) prior to therapy programme and intensive physical and occupational therapy programme
Group B: BtA injections only
Group C: Intensive physical and occupational therapy programme
Group D: Usual care

BtA injections:
The most spastic muscles hampering function will be injected. Dysport® dilution: 25 U/0.1 ml, dose 6 - 9 U/kg body weight muscles above elbow, 3 - 6 U/kg body weight muscles in forearm, limited to no more than 150 units (0.6 ml) at any one injection site. In the intrinsic thumb muscles the maximum dose will be 25 U per muscle. A maximum Dysport® dose of 1,000 U per child in total per session will be used.

Intensive physical and occupational therapy programme:
Participants will receive one hour of ocupational therapy and 30 minutes of physical therapy, twice a week for 12 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Botulinum toxin A (Dysport®)

Primary outcome measures

1. Assisted Hand Assessment (AHA): original test kit for children 2.5 - 6 years and board game for children 7 - 12 years (T2, T4, T6)
2. A measure of manual ability for children with upper limb impairments (ABILHAND)-Kids questionnaire (T1 - T6)
3. Canadian Occupational Performance Measure (COPM): establishing treatment goals; Goal Attainment Scaling (GAS) of the most important bimanual treatment goal (T1, T4, T6)
4. Video recording of two fine motor tasks (children 7 - 12 years: buttering and cutting bread, screw construction task; children 2.5 - 6 years: building with 'poppons', threading beads) and one gross motor task (children 2.5 - 6 years: building blocks; children 7 - 12 years: stacking cylinders). These videos will be scored with newly developed and reliability tested Video Observation (VO) criteria (T2, T6).

T1 and T2: Baseline
T3: 6 weeks after btA and start of the therapy program
T4: 12 weeks, end of therapy program
T5: 18 weeks
T6: 24 weeks

Secondary outcome measures

1. Wrist and elbow tone and Tardieu Scale or Spasticity Test (SPAT): supine and sitting (T1 - T6)
2. Active and passive range of motion (ROM) of wrist (with fisted hand and with extended fingers), and of elbow and thumb (T1 - T6)
3. Grip strength: E-link (biometrics®) and functional grip strength (T1 - T6)

T1 and T2: Baseline
T3: 6 weeks after btA and start of the therapy program
T4: 12 weeks, end of therapy program
T5: 18 weeks
T6: 24 weeks

Overall trial start date

01/01/2008

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 2.5 - 12 years, either sex
2. Cerebral palsy
3. Hagberg diagnosis: spastic hemiparesis or extreme asymmetric diplegia
4. Hand function impairment Zancolli grade I with evident problems in thumb extension and supination, Zancolli grade IIA and IIB
5. Mentally able to comprehend and perform tasks
6. Children and their parents should be able to cope with the intensive rehabilitation therapy programme and the measurement sessions
7. Children and the parents/caregivers should comprehend and speak Dutch
8. Children and their parents indicate the necessity for improvement of the children's abilities

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60 in total, 20 per participating centre

Participant exclusion criteria

1. Severe structural contractures of the muscles at the extremity to be treated:
1.1. Passive elbow extension maximum 160 degrees or less
1.2. Supination maximum 30 degrees or less from neutral position
1.3. Wrist dorsal flexion maximum 20 degrees or less in children aged 2.5 - 6 years, or 45 degrees or less in age group 7 - 12 years
2. Severe impairment of hand function: no active hand function is expected after treatment (Zancolli III)
3. Hand surgery or phenolisation or btA injections in the arm less than nine months ago
4. Contraindication for botulinum toxin (muscular diseases such as myasthenia gravis, tetanus vaccination less than three months before the injection, use of aminoglycoside antibiotics or spectinomycine and known hypersensitivity for human albumin)
5. Contraindication for anaesthesia
6. Children who cannot bear touching the affected arm and hand

Recruitment start date

01/01/2008

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Franciscusoord Child Rehabilitation
Valkenburg
6301 KA
Netherlands

Sponsor information

Organisation

Ipsen Biopharm Ltd (UK)

Sponsor details

Ashroad
Wrexham Industrial Estate
Wrexham
LL13 9UF
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Research organisation

Funder name

Rotterdam Foundation Child Rehabilitation Fund 'Adriaan Fund' (Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Johanna Children's Fund (Johanna Kinderfonds) (The Netherlands) - http://www.johannakinderfonds.nl

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Phelps Foundation for Spasticity (Phelps Stichting voor Spastici) (The Netherlands) - http://www.phelps-stichting.nl

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Profile Fund of the University Hospital Maastricht (Profileringsfonds azM) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation for Children's Illness (Stichting het gebrekkige Kind) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ipsen Biopharm Ltd (UK) - provided Dysport®

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26286662

Publication citations

Additional files

Editorial Notes