Improvement on GMFCS Level of Patients With Cerebral Palsy Treated by Repeated Botulinum Toxin-A

NCT03344952 | Completed

• 1 other identifier: KU GOKAEK 2017/90
• Study Type: observational
• Target: 503
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this retrospective, monocenter, observational study is to evaluate the changes in GMFCS levels of children with cerebral palsy (CP) who received repeated Botulinum Toxin-A (BoNT-A) injections in the lower limb(s) with an integrated treatment approach in Kocaeli University Department of PMR and Izmit Rehabilitation Center.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Gross Motor Functional Classification System (GMFCS)

  Motor development

  10 years

Secondary Outcomes (3)

• Modified Ashworth Scale (MAS)

  Before and 4-6 weeks after each injection

• Angle of catch (XV3) of Modified Tardieu Scale (MTS)

  Before and 4-6 weeks after each injection

• Observational Gait Scale (OGS)

  Before and 4-6 weeks after each injection

Interventions

Botulinum toxin type A DRUG

Repeated injections to hypertonic muscles

Also known as: Botox, Dysport

Physical therapy OTHER

3 weeks intensive program 1 week -10 days after BoNT-A injections

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children diagnosis of cerebral palsy with respect to Rosenbaum criteria having received at least 2 repeated BoNT-A injections to lower limb(s) as well as an integrated treatment approach (an intensive therapy protocol consisted of a half day or entire day program in Kocaeli University Department of PMR and Izmit Rehabilitation Center) within the last 10 years

You may qualify if:

• All children with a diagnosis of cerebral palsy with respect to Rosenbaum criteria
• Children who received at least 2 repeated BoNT-A injections to lower limb(s) as well as an integrated treatment approach (an intensive therapy protocol consisted of a half day or entire day program in Kocaeli University Department of PMR and Izmit Rehabilitation Center) within the last 10 years

You may not qualify if:

• Children who did not receive repeated injections
• Children who did not receive an intensive therapy protocol

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Therapeutics; Rehabilitation

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: November 20, 2017
• Primary Completion: October 10, 2018
• Study Completion: November 9, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)