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

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN69541857
• Date of registration: 31/03/2008
• Prospective Registration: No
• Primary sponsor: Ipsen Biopharm Ltd (UK)
• 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: Effect of botulinum toxin A injections and specific intensive rehabilitation therapy in children with hemiparetic cerebral palsy on upper limb functions and skills
• Date of first enrolment: 01/01/2008
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN69541857
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Netherlands

Contacts

• Name: Lucianne Speth

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cerebral palsy
Nervous System Diseases
Cerebral palsy

Intervention(s)

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(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(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

Secondary ID(s)

NL12005.096.06

Source(s) of Monetary Support

Rotterdam Foundation Child Rehabilitation Fund 'Adriaan Fund' (Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting) (The Netherlands), Johanna Children's Fund (Johanna Kinderfonds) (The Netherlands) - http://www.johannakinderfonds.nl, Phelps Foundation for Spasticity (Phelps Stichting voor Spastici) (The Netherlands) - http://www.phelps-stichting.nl, Profile Fund of the University Hospital Maastricht (Profileringsfonds azM) (The Netherlands), Foundation for Children's Illness (Stichting het gebrekkige Kind) (The Netherlands), Ipsen Biopharm Ltd (UK) - provided Dysport®