Effect of botulinum toxin A injections and specific intensive rehabilitation therapy in children with hemiparetic cerebral palsy on upper limb functions and skills
| ISRCTN | ISRCTN69541857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69541857 |
| Secondary identifying numbers | NL12005.096.06 |
- Submission date
- 04/12/2007
- Registration date
- 31/03/2008
- Last edited
- 20/08/2015
- 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
Not provided at time of registration
Contact information
Mrs Lucianne Speth
Scientific
Scientific
Franciscusoord Child Rehabilitation
Onderstestraat 29
Valkenburg
6301 KA
Netherlands
| Phone | +31 (0)455 282 615 |
|---|---|
| LSpeth@T-Online.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study 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(s) | 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) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Botulinum toxin A (Dysport®) |
| Primary outcome measure | 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 study start date | 01/01/2008 |
| Overall study end date | 01/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2.5 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 60 in total, 20 per participating centre |
| 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 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
Study participating centre
Franciscusoord Child Rehabilitation
Valkenburg
6301 KA
Netherlands
6301 KA
Netherlands
Sponsor information
Ipsen Biopharm Ltd (UK)
Industry
Industry
Ashroad
Wrexham Industrial Estate
Wrexham
LL13 9UF
United Kingdom
"ROR" |
https://ror.org/00gmnqd91 |
|---|
Funders
Funder type
Research organisation
Rotterdam Foundation Child Rehabilitation Fund 'Adriaan Fund' (Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting) (The Netherlands)
No information available
Johanna Children's Fund (Johanna Kinderfonds) (The Netherlands) - http://www.johannakinderfonds.nl
No information available
Phelps Foundation for Spasticity (Phelps Stichting voor Spastici) (The Netherlands) - http://www.phelps-stichting.nl
No information available
Profile Fund of the University Hospital Maastricht (Profileringsfonds azM) (The Netherlands)
No information available
Foundation for Children's Illness (Stichting het gebrekkige Kind) (The Netherlands)
No information available
Ipsen Biopharm Ltd (UK) - provided Dysport®
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/08/2015 | Yes | No |
