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Completed

NCT Number: NCT03344952

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

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli University

Kocaeli, 41050, Turkey (Türkiye)

About this study

It is generally agreed that children with CP reach their gross motor potential by the age of 3.5-5 and a child or young person over the age of 5 years will not improve their GMFCS level. BoNT-A is an important treatment in children with CP because it is safe in young children and allows combined treatment. The reduction in muscle tone by this selective treatment provides an opportunity to allow and optimize the effects of other treatments including orthoses, casting, conventional therapies and activity based functional trainings. For this reason, BoNT-A injections are always combined with other therapies in Kocaeli University Department of PMR and Izmit Rehabilitation Center. Adjunctive treatments in this department consists of serial casting, orthotics, physical therapy, occupational therapy, cognitive rehabilitation, special educational programs, non invasive brain stimulation with transcranial direct current, neurofeedback, biofeedback, electrical stimulation and other physical therapy modalities, activity based models including functional ambulatory training, constraint induced therapy, bilateral therapy, hippotherapy, music therapy by singing or playing percussive instruments or moving and dancing to music, and robotic rehabilitation. Individualized intensive combined treatment plan was applied by an appropriate neurorehab team to each patient within the department as a half day or full day program usually for 3 weeks starting 1 week or 10 days after BONT-A injections. In thıs retrospective, monocenter, observational study a software database program will be developed and all the present data about the demographic and clinic properties of the patients, all information about BoNT-A injections including safety and applied adjunctive treatments will be entered and reviewed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Repeated injections to hypertonic muscles

Other names: Botox, Dysport

Physical Therapy

Other

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

Primary outcomes

  1. Gross Motor Functional Classification System (GMFCS)

    Time frame: 10 years

    Motor development

Secondary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: Before and 4-6 weeks after each injection

    Assessment of tone

  2. Angle of catch (XV3) of Modified Tardieu Scale (MTS)

    Time frame: Before and 4-6 weeks after each injection

    Assessment of spasticity

  3. Observational Gait Scale (OGS)

    Time frame: Before and 4-6 weeks after each injection

    OGS is a measurement tool for analysis of gait consisting of seven gait parameters with a total score of 20.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

Long Term Improvement on GMFCS Level of Patients With Cerebral Palsy Treated by an Integrated Approach of Repeated Botulinum Toxin-A Injections

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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