Muscle mass change after BoNT-A injection in cerebral palsy

Changes of mass of muscle measured by DEXA after botulinum toxin injection in spastic hemiplegic cerebral palsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004591

Enrollment

Registered

2019-12-31

Start date

2017-05-30

Completion date

Unknown

Last updated

2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : They received the BoNT-A injections to the affected medial gastrocnemius (GCM) muscle with dose of 2-5 U /kg.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Spastic hemiplegic cerebral palsy 2. age between 2-18 years

Exclusion criteria

Exclusion criteria: 1. those who had an allergic reaction to BoNT-A; 2. those who, at screening, were participating in other clinical trials or were taking muscle relaxants, benzodiazepine, or anticholinergic drugs within four weeks of screening 3. those who had received a botulinum toxin injection within the previous six months 4. those who had been treated with intrathecal baclofen, selective dorsal rhizotomy, or other orthopedic surgery.

Design outcomes

Primary

Measure	Time frame
The ratio of lean body mass of injected leg to non-injected leg after botulinum toxin injection	—

Secondary

Measure	Time frame
The ratio of lean body mass of injected leg or non-injected leg to total body after botulinum toxin injection	—

Countries

Korea, Republic of

Contacts

Public ContactDae-hyun Jang

The Catholic University of Korea, Incheon St. Mary's Hospital

Outcome results