Effects of Botulinum injections on the development of arm and hand function in children with unilateral spastic cerebral palsy

Effects of Botulinum injections and occupational therapy on arm and hand function in children with unilateral spastic cerebral palsy compared to occupational therapy alone

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84681422

Enrollment

Registered

2013-11-26

Start date

2004-10-25

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral spastic cerebral palsy Nervous System Diseases Spastic diplegic cerebral palsy

Interventions

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 assi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Intellectual disability interfering with the intervention program 2. Upper limb dystonia 3. Previous upper limb surgery or Botulinum toxin injections

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026