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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05207124
• Other study ID #: B-BR-108-088
• Status: Enrolling by invitation
• Start date: September 2, 2020
• Est. completion date: July 2025

Study information

• Verified date: January 2022
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: August 2023
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Cerebral Palsy
• Sarcopenia

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DXA (dual-energy x-ray absorptiometry)	dual-energy x-ray absorptiometry	change from baseline at 24 weeks after botulinum neurotoxin type A injection