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

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ClinicalTrials.gov Identifier: NCT03344952
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Nigar Dursun, Kocaeli University

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.

Condition or disease Intervention/treatment
Cerebral Palsy Drug: Botulinum toxin type A Other: Physical therapy

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long Term Improvement on GMFCS Level of Patients With Cerebral Palsy Treated by an Integrated Approach of Repeated Botulinum Toxin-A Injections
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Botulinum toxin type A
    Repeated injections to hypertonic muscles
    Other Name: Botox, Dysport
  • Other: Physical therapy
    3 weeks intensive program 1 week -10 days after BoNT-A injections


Primary Outcome Measures :
  1. Gross Motor Functional Classification System (GMFCS) [ Time Frame: 10 years ]
    Motor development


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344952


Locations
Turkey
Kocaeli University Recruiting
Kocaeli, Turkey, 41050
Contact: Nigar Dursun, MD    905334322568    nigard@hotmail.com   
Contact: Melike Akarsu, BA    905326624633    sirinmelik@yahoo.com   
Sponsors and Collaborators
Kocaeli University

Responsible Party: Nigar Dursun, Professor, MD, Kocaeli University
ClinicalTrials.gov Identifier: NCT03344952     History of Changes
Other Study ID Numbers: KU GOKAEK 2017/90
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents