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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344952
• Other study ID #: KU GOKAEK 2017/90
• Status: Completed
• Start date: November 20, 2017
• Est. completion date: November 9, 2018

Study information

• Verified date: November 2018
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: November 9, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Drug:
• Botulinum toxin type A
Repeated injections to hypertonic muscles

Other:
• Physical therapy
3 weeks intensive program 1 week -10 days after BoNT-A injections

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Functional Classification System (GMFCS)	Motor development	10 years
Secondary	Modified Ashworth Scale (MAS)	Assessment of tone	Before and 4-6 weeks after each injection
Secondary	Angle of catch (XV3) of Modified Tardieu Scale (MTS)	Assessment of spasticity	Before and 4-6 weeks after each injection
Secondary	Observational Gait Scale (OGS)	OGS is a measurement tool for analysis of gait consisting of seven gait parameters with a total score of 20.	Before and 4-6 weeks after each injection