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.

• Register: EUCTR
• Last refreshed on: 27 January 2025
• Main ID: EUCTR2009-015620-29-BE
• Date of registration: 09/02/2010
• Prospective Registration: Yes
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 08/03/2010
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015620-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 unit(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscular use

Primary Outcome(s)

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

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.

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

Secondary ID(s)

2009/1314

Ethics review

Status: Approved
Approval date: 26/01/2010
Contact: