The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study

NCT03680196 | Completed DMC

• 1 other identifier: B-1807-478-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In children with cerebral palsy, secondary problems lead to hip dislocation. the purpose of this study is to find out the effects of botulinum toxin A on hip joint dislocation in cerebral palsy patients.

Conditions

Cerebral Palsy

Keywords

hip dislocation; GMFCS level 3,4,5

Outcome Measures

Primary Outcomes (1)

• Change from hip adductor and spin muscles electromyography(EMG) test at a month

  Use EMG to check the activity of the hip adductor and spine muscles of participants. This figures will give investigators a look at the association with a hip dislocation.

  once at study, when patient enrolled and every once a month for one year

Secondary Outcomes (5)

• Whole spine AP and total Hip AP X-ray photograph

  once at study, when patient enrolled and and after six month for one year

• hip adductor muscles pressure meter test

  once at study, when patient enrolled and every once a month for one year

• Likert scale

  once at study, when patient enrolled and every once a month for one year

• Hip and knee joint Range of motion(ROM) test

  once at study, when patient enrolled and every once a month for one year

• CPCHILD sacle

  once at study, when patient enrolled and every once a month for one year

Study Arms (1)

cerebral palsy patients

EXPERIMENTAL

cerebral palsy patients who have GMFCS level3,4,5 and 2 years old and under 10 years old apply an A injection of medication Botulinum A injection

Drug: medication Botulinum A injection.

Interventions

medication Botulinum A injection. DRUG

In cerebral palsy patients, Botulinum toxin within the allowable dose of 16 U / kg per body weight will injected into both adductor longus, adductor magnus muscle at 3 U / kg, adductor brevis, and gracilis muscle at a dose of 1 U / kg.

cerebral palsy patients

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Severe cerebral palsy patients(GMFCS level 3,4,5)
• to 10 years old

You may not qualify if:

• Those who disagree with the study.
• other than cerebral palsy.

Sponsors & Collaborators

• Ju Seok Ryu: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy; Hip Dislocation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Jusuk Ryu

  Seoul National University Bundang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 21, 2018
• Study Start: December 6, 2018
• Primary Completion: September 1, 2020
• Study Completion: August 30, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

KR (1)