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Clinical Trials/EUCTR2009-009868-31-NL
EUCTR2009-009868-31-NL
Active, not recruiting
Not Applicable

Quality of life, gross motor function, and actual everyday physical activity level in children with spastic Cerebral Palsy: (cost)effectiveness of combined treatment with multilevel botulinum-toxin injections and intensive functional physiotherapy.

ZonMW0 sitesMay 4, 2009
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ConditionsSpastic Cerebral Palsy, GMFCS levels I-III
DrugsBotox

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spastic Cerebral Palsy, GMFCS levels I-III
Sponsor
ZonMW
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 4, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ZonMW

Eligibility Criteria

Inclusion Criteria

  • •Children with spastic Cerebral Palsy aged 4\-12 years whose lower extremity is involved and who have been selected for treatment with multilevel botulinum toxin injections followed by intensive physiotherapy are eligible candidates.
  • •Spastic CP will be diagnosed according to the guidelines of the Dutch Institute for Healthcare Improvement. Only children classified as levels I\-III with the Gross Motor Function Classification System (GMFCS) will be included for the study because they are (household) ambulators.
  • •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’s´ motor selectivity should be sufficient (to be measured by valid selectivity test), and they are excluded in case of surgery \<12 months before the study and in case of BtA treatment \<6 months preceding the study. Children will also be excluded when severe contractures are present, when they are cognitively unable to understand instructions, or when there is co\-morbidity (e.g. visual disability, severe epilepsis) that affects their everyday functioning.

Outcomes

Primary Outcomes

Not specified

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