Effects of Botulinum injections on the development of arm and hand function in children with unilateral spastic cerebral palsy
| ISRCTN | ISRCTN84681422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84681422 |
| Secondary identifying numbers | 151:109/01 (Medical Products Agency Sweden) |
- Submission date
- 26/10/2013
- Registration date
- 26/11/2013
- Last edited
- 08/01/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
Box 210 62
Göteborg
SE 41804
Sweden
Study information
| Study design | Randomized 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 | Effects of Botulinum injections and occupational therapy on arm and hand function in children with unilateral spastic cerebral palsy compared to occupational therapy alone |
| Study objectives | Botulinum toxin and occupational therapy increase hand function more than occupational therapy alone. |
| Ethics approval(s) | Medical Faculty University of Gothenburg,11 January 2001, ref: Ö 177-00 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 25/10/2004 |
| Completion date | 20/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 18 Months |
| Upper age limit | 10 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key exclusion criteria | 1. Intellectual disability interfering with the intervention program 2. Upper limb dystonia 3. Previous upper limb surgery or Botulinum toxin injections |
| Date of first enrolment | 25/10/2004 |
| Date of final enrolment | 20/08/2011 |
Locations
Countries of recruitment
- Sweden
Study participating centre
SE 41804
Sweden
Sponsor information
Hospital/treatment centre
c/o Dr Kate Himmelmann
Regional Rehabilitation Centre for Children and Adolescents
Box 210 62
Göteborg
SE 41804
Sweden
"ROR" |
https://ror.org/00yqpgp96 |
|---|
Funders
Funder type
Government
No information available
No information available
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 |
