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

• Conditions: Cerebral Palsy

• Registration Number: NCT05207124
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2020-09-02
• Study First Submitted: 2021-10-04
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-26
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30
• Primary Completion: 2023-08
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DXA (dual-energy x-ray absorptiometry)	change from baseline at 24 weeks after botulinum neurotoxin type A injection	dual-energy x-ray absorptiometry

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan