Architectural changes of muscles after botulinum toxin injection in children with hemiplegic cerebral palsy

Architectural changes of muscles after botulinum toxin injection and intensive stretching exercise in children with hemiplegic cerebral palsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004018

Enrollment

Registered

2019-05-31

Start date

2017-05-30

Completion date

Unknown

Last updated

2019-06-17

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) 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
medial gastrocnemius muscle thickness in toxin-injected compared with unaffected side (affected side medial gastrocnemius thickness/unaffected side*100)	—

Secondary

Measure	Time frame
medial gastrocnemius fascicle length and fascicle angle in toxin-injected compared with unaffected side (affected side medial gastrocnemius fascicle length and fascicle angle /unaffected side*100)	—

Countries

Korea, Republic of

Contacts

Public ContactYou Gyoung Yi

Seoul National University Hospital

lyk861124@gmail.com+82-2-2225-4339

Outcome results