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

September 29, 2022 updated by: National Cheng-Kung University Hospital

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

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 Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 138
        • Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cerebral palsy is vulnerable for osteopenia and sarcopenia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Botulinum toxin injection group
onabotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DXA (dual-energy x-ray absorptiometry)
Time Frame: change from baseline at 24 weeks after botulinum neurotoxin type A injection
dual-energy x-ray absorptiometry
change from baseline at 24 weeks after botulinum neurotoxin type A injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-BR-108-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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