The efficacy of the Botulinum toxin-A on the manual abilities in children with congenital spastic hemiplegia. Interest of the measure of the bimanual task performance.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015620-29-BE

Enrollment

Registered

2010-02-09

Start date

2010-03-08

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

The main objective of this study is to investigate the effect of Botulinum toxin A to improve the Upper Limb dysfunction in Hemiplegic Cerebral Palsy Children and in particular, its impact on Upper limb activity performance and how this might be translate in bimanual activities. MedDRA version: 12.0 Level: LLT Classification code 10019475 Term: Hemiplegic infantile cerebral palsy

Interventions

Trade Name: BOTOX Product Name: BOTOX Product Code: 9060X Pharmaceutical Form: Injection* CAS Number: 93384-43-1 Other descriptive name: BOTULINUM TOXIN TYPE A Concentration unit: IU international u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The participants to this study are aged between 4 and 12 years and have a diagnosis of congenital hemiplegia affecting upper-limb activities but not significative fixed contractures. They have a Manual Ability Classification system( MACS) level between 1 and 4 and a normal education or an IQ > 70. They must have an adapted physiotherapy program before and minimum 9 months after the treatment. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The children who had injection within 6 months previous the inclusion in the lower limb and 9 months in the upper limb will be excluded. Children who participated at a constraint-induced therapy (CIMT) program the year before the study will be automatically excluded.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to investigate the effect of Botulinum toxin A to improve the Upper limb dysfunction in Hemiplegic CP Children and in particular, its impact on Upper Limb activity performance and how this might be translate in bimanual activities. ;Secondary Objective: The second objective is to demonstrate the utility of the Assisting Hand Assessment (AHA) test in the assessment of the effect of Botulinum toxin A on bi-manual activities;Primary end point(s): The main result that is measured at the end of a study is the outcome at 9 months after injection for each group : - at thelevel of deficiency, the investigator will assess the spasticity by the modified Ashworth scale, the grip force by Jamar dynamometer, the joint range of motion by goniometer, the box and block test to measure the manual dexterity. - at the level of activities limitations, we evaluate the children ability to perform daily activities with their upper limbs by using the PEDI and the abilhand-kids questionnaire. - at the level of participation, we give the questionnaire developed by Fougeyrollas : the Assessment of Life Habits ou MHAVIE- Children	—

Measure

Time frame

Main Objective: The main objective of this study is to investigate the effect of Botulinum toxin A to improve the Upper limb dysfunction in Hemiplegic CP Children and in particular, its impact on Upper Limb activity performance and how this might be translate in bimanual activities. ;Secondary Objective: The second objective is to demonstrate the utility of the Assisting Hand Assessment (AHA) test in the assessment of the effect of Botulinum toxin A on bi-manual activities;Primary end point(s): The main result that is measured at the end of a study is the outcome at 9 months after injection for each group : - at thelevel of deficiency, the investigator will assess the spasticity by the modified Ashworth scale, the grip force by Jamar dynamometer, the joint range of motion by goniometer, the box and block test to measure the manual dexterity. - at the level of activities limitations, we evaluate the children ability to perform daily activities with their upper limbs by using the PEDI and the abilhand-kids questionnaire. - at the level of participation, we give the questionnaire developed by Fougeyrollas : the Assessment of Life Habits ou MHAVIE- Children

—

Countries

Belgium

Outcome results

None listed

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