Plain English Summary
Background and study aims
Children with unilateral spastic cerebral palsy often have impaired hand function. This study aims to find out if Botulinum toxin injections, training of hand function and use of a night splint gives a better improvement than training of hand function and use of a night splint alone.
Who can participate?
Children with unilateral spastic cerebral palsy living in western Sweden.
What does the study involve?
Children will be randomly allocated to one of two groups. One group will be treated with Botulinum toxin injections in the upper limb twice in one year, will use a night splint and will receive two 8-week intensive periods of occupational therapy in one year. The other group will receive occupational therapy. Investigations will take place before the start of the study and at 3, 6, 9 and 12 months after the start of the study.
What are the possible benefits and risks of participating?
A benefit would be the close follow-up and focus on hand function. Possible risks would be adverse effects from Botulinum toxin in those allocated to receive injections.
Where is the study run from?
The study is run from The Regional Rehabilitation Centre for Children and Adolescents at the Queen Silvia Childrens Hospital, Sweden.
When is the study starting and how long is it expected to run for?
The study started in October 2004 and ran until August 2011.
Who is funding the study?
The study is funded by several research foundations and The Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland and Göteborg & Södra Bohuslän, Sweden.
Who is the main contact?
Git Lidman, Occupational therapist, Queen Silvia Children's Hospital
git.lidman@vgregion.se
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
151:109/01 (Medical Products Agency Sweden)
Study information
Scientific title
Effects of Botulinum injections and occupational therapy on arm and hand function in children with unilateral spastic cerebral palsy compared to occupational therapy alone
Acronym
Study hypothesis
Botulinum toxin and occupational therapy increase hand function more than occupational therapy alone.
Ethics approval
Medical Faculty University of Gothenburg,11 January 2001, ref: Ö 177-00
Study design
Randomized 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
Unilateral spastic cerebral palsy
Intervention
Upper limb Botulinum toxin injections twice in one year
Night splint
Occupational therapy: two 8-week intensive periods in one year
Twenty children (median age of 3 years 1 month) were randomly assigned to one of two groups of ten children each.
1. BoNT-A+OT group: Botulinum toxin injections in the upper limb twice in one year plus night splint plus two 8-week intensive periods of occupational therapy in one year
2. OT group: occupational therapy alone
All assessments performed by two occupational therapists who were aware of the child's intervention but were blinded to the previous measurements. A third occupational therapist scored the Assisting Hand Assessment (AHA) test, blinded to group allocation and order of assessments. Both groups had two 8-week blocks of therapy. This involved the implementation of a home program and a weekly session with an occupational therapist, intended to help the parents maintain and adjust the therapy. A static circular night splint was individually made.
Education and guidelines to the parents for the home program including: bimanual therapy (1h/day), splint (8h/night), manual stretching of the injected muscles and implementation of the goals in daily life (once/day), and a log book for documentation of treatment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Range of motion (ROM) (active and passive) in the joints of the upper limb at baseline, 3, 6, 9 and 12 months
2. Assisting Hand Assessment (AHA) (capacity of hand activity) at baseline, 3, 6, 9 and 12 months
3. Canadian Occupation Performance Measure (COPM) (performance of hand activity) at baseline, 3, 6, 9 and 12 months
4. Covering all domains of ICF (International Classification of Functioning, Disability and Health) regarding the affected upper limb in children with unilateral spastic cerebral palsy
In the group randomized to Botulinum toxin injections at baseline and 6 months, the assessments were also made at 1 and 7 months, to capture the maximum effect of the injections.
Secondary outcome measures
Range of movement (ROM), Assisting Hand Assessment (AHA), and Canadian Occupational Performance Measure (COPM) are performed, as well as documentation of hand surgery and Botulinum toxin treatment at 24, 26 48 and 60 months.
Overall trial start date
25/10/2004
Overall trial end date
20/08/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Unilateral spastic cerebral palsy with spasticity in the upper limb, typically in the pronator, thumb muscles and elbow flexors
2. Age 18 months to 10 years
3. Living in Västra Götaland
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Intellectual disability interfering with the intervention program
2. Upper limb dystonia
3. Previous upper limb surgery or Botulinum toxin injections
Recruitment start date
25/10/2004
Recruitment end date
20/08/2011
Locations
Countries of recruitment
Sweden
Trial participating centre
Box 210 62
Göteborg
SE 41804
Sweden
Funders
Funder type
Government
Funder name
The Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland and Göteborg & Södra Bohuslän (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Norrbacka-Eugenia and Folke Bernadotte Foundations (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Sunnerdahl and Petter Silfverskiöld Foundations (Sweden)
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