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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | Effect of botulinum toxin A injections and specific intensive rehabilitation therapy in children with hemiparetic cerebral palsy on upper limb functions and skills |
| Scientific title | |
| Acronym | BoBiVa (Botuline toxine Bimanuele Vaardigheden) |
| Serial number at source | NL12005.096.06 |
| 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 |
Ethics approval received from the Medical Ethics Committee of the Meuse Hospital (Medisch Ethische Toetsingscommissie Atrium MC-Maaslandziekenhuis) on the 27th July 2006.
This trial is also registrated 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 |
| Countries of recruitment | The Netherlands |
| Disease/condition/study domain | Cerebral palsy |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2008 |
| Anticipated end date | 01/01/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 60 in total, 20 per participating centre |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding |
1. Rotterdam Foundation Child Rehabilitation Fund 'Adriaan Fund' (Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting) (The Netherlands)
2. Johanna Children's Fund (Johanna Kinderfonds) (The Netherlands) - http://www.johannakinderfonds.nl 3. Phelps Foundation for Spasticity (Phelps Stichting voor Spastici) (The Netherlands) - http://www.phelps-stichting.nl 4. Profile Fund of the University Hospital Maastricht (Profileringsfonds azM) (The Netherlands) 5. Foundation for Children's Illness (Stichting het gebrekkige Kind) (The Netherlands) 6. Ipsen Biopharm Ltd (UK) - provided Dysport® |
| Trial website | http://www.srl.nl/default.asp?id=396&parent=0&template=algemeen.htm&sitecat=5 |
| Publications | |
| Contact name | Mrs Lucianne Speth |
| Address |
Franciscusoord Child Rehabilitation
Onderstestraat 29 |
| City/town | Valkenburg |
| Zip/Postcode | 6301 KA |
| Country | Netherlands |
| Tel | +31 (0)455 282 615 |
| Fax | +31 (0)455 282 120 |
| LSpeth@T-Online.de | |
| Sponsor | Ipsen Biopharm Ltd (UK) |
| Address |
Ashroad
Wrexham Industrial Estate |
| City/town | Wrexham |
| Zip/Postcode | LL13 9UF |
| Country | United Kingdom |
| Date applied | 04/12/2007 |
| Last edited | 31/03/2008 |
| Date ISRCTN assigned | 31/03/2008 |
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