Condition category
Nervous System Diseases
Date applied
26/10/2013
Date assigned
26/11/2013
Last edited
08/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 Children’s 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

Contact information

Type

Scientific

Primary contact

Dr Kate Himmelmann

ORCID ID

Contact details

Box 210 62
Göteborg
SE 41804
Sweden

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

Sponsor information

Organisation

Queen Silvia Children's Hospital (Sweden)

Sponsor details

c/o Dr Kate Himmelmann
Regional Rehabilitation Centre for Children and Adolescents
Box 210 62
Göteborg
SE 41804
Sweden

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes