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Sarcopenia and Osteopenia in Individuals With Cerebral Palsy and Influences After Botulinum Neurotoxin Type A Injection

N

National Cheng-Kung University

Status

Invitation-only

Conditions

Cerebral Palsy

Study type

Observational

Funder types

Other

Identifiers

NCT05207124
B-BR-108-088

Details and patient eligibility

About

Botulinum neurotoxin type A (BoNT-A) intervention to control the hypertonia of muscles is one of the evidence-based managements for children with spastic cerebral palsy. However, BoNT-A injection in animal models to induce weakness had revealed some detrimental effects on muscular and skeletal systems. There are some objectives of this research. The first aim is to establish the baseline data of deficiencies in bone condition and muscle mass for individuals with cerebral palsy. To confirm the influences of intramuscular administration of Botox on muscular and bony health in this population is the other aim.

Full description

Individuals with cerebral palsy is vulnerable to osteopenia and sarcopenia. Botulinum neurotoxin type A (BoNT-A) intervention to control the hypertonia of muscles is one of the evidence-based managements for children with spastic cerebral palsy. However, BoNT-A injection in animal models to induce weakness had revealed some detrimental effects on muscular and skeletal systems. There are some objectives of this research. The first aim is to establish the baseline data of deficiencies in bone condition and muscle mass for individuals with cerebral palsy. To confirm the influences of intramuscular administration of Botox on muscular and bony health in this population is the other aim.

Enrollment

60 estimated patients

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. diagnosis of spastic CP (cerebral palsy)
  2. moderate to severe spasticity over the limbs, Modified Ashworth Scale score≧2

Exclusion criteria

  1. fixed contractures of the limbs
  2. previous musculoskeletal surgery on the limbs
  3. contraindications to botulinum toxin intervention

Trial design

60 participants in 1 patient group

Botulinum toxin injection group
Description:
onabotulinumtoxinA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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