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Effects of Botulinum Toxin Injection on Sensation and Postural Control in Children With Hemiplegic Cerebral Palsy

NCT04940143 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-07-02

No results posted yet for this study

Summary

In this study, the investigators aimed to investigate the effects of botulinum neurotoxin type A (BoNT-A) injection applied to the ankle plantar flexor muscles on lower extremity sensation and quantitative balance parameters in children with spastic hemiplegic cerebral palsy who are ambulatory without an assistive device in daily life.

Conditions

  • Cerebral Palsy
  • Hemiplegic Cerebral Palsy

Interventions

DRUG

Botulinum toxin type-A (Onabotulinum toxin type-A)

Botulinum toxin-A (Onabotulinum toxin type-A/Botox®) injection will be administered from three different points, two on the medial head of the gastrocnemius muscle and one point on the lateral head with total 3-6 units/kg dose, under the guidance of electrical stimulation for the detection of the target neuromuscular junction.

OTHER

Physical Therapy

After the botulinum toxin-A injection, the patients will be included in the comprehensive physiotherapy program thrice a week for a total of 12 weeks. The physiotherapy program will be consisted of the ankle range of motion and stretching, strengthening of the antagonist muscles, proprioception exercises, functional walking training and static and dynamic balance training.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Evrim Karadag Saygi, Prof · Marmara University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-07-31
Completion
2021-09-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04940143 on ClinicalTrials.gov