Clinical trial NCT03788317: Improved Sitting Balance: Body Functions to Participation
Official title: Integrated Botulinum Toxin for Improved Sitting Balance in Children With Cerebral Palsy: Body Functions to Activity and Participation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy, Botulinum Toxin A, Participation
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 29
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children diagnosis of cerebral palsy with respect to Rosenbaum criteria having received BoNT-A injections to lower limb(s) as well as an integrated treatment approach

Brief summary: The aim of this study is to evaluate the changes in activity and participation domains of International Classification of Functioning, Disability and Health (ICF) in children with cerebral palsy (CP) who received integrated Botulinum Toxin-A (BoNT-A) injections into the lower limb(s) with a treatment goal of improved sitting balance.

Detailed description: Postural problems play a substantial role in activities of daily living in children with CP having Gross Motor Function Classification System (GMFCS) levels IV or V. Improvement in sitting balance may positively effect the performance and caregiving of vital tasks of daily life in these children and may furtherly improve the quality of life of both the child and family. BoNT-A is an important treatment in children with CP because it is safe in young children and allows combined treatment. In the current literature its efficacy on body functions and structures by hypertonia management is well known. However there is inconclusive evidence for improvement in activity and participation domains of ICF with BoNT-A. CP is a very heterogenous population and in most of the studies the inclusion criteria do not adress level of underlying motor control and the primary efficacy assessment methods were usually chosen to cover hypertonia. Besides generally the efficacy endpoints were so soon to detect changes in activity or participation domains of ICF. Lack of association of rehabilitation programs is another important concern for the current clinical studies.

In this present study a well defined subpopulation of CP children having GMFCS levels of IV or V who each received integrated BoNT-A treatment with a primary goal of improved sitting balance will be recruited to identify the probable changes in activity and participation domains of ICF as well as changes in quality of life of the family and the child.

Eligibility criteria: Inclusion Criteria:

* All children with a diagnosis of cerebral palsy with respect to Rosenbaum criteria
* Gross Motor Functional Classification Scale level of IV-V
* Being scheduled for BoNT-A treatment to lower extremity
* Primary goal of treatment selected as improved sitting balance

Exclusion Criteria:

* Severe cognitive or behavioural problems
* Severe dystonia

Primary outcomes:
measure: The Child and Adolescent Scale of Participation (CASP)
timeFrame: 20 weeks
measure: The Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)
timeFrame: 20 weeks
Secondary outcomes:
measure: Goal Assessment Scale (GAS)
timeFrame: 20 weeks
Other outcomes:
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: 20 weeks
measure: Mean change from baseline Modified Ashworth Scale (MAS)
timeFrame: 20 weeks
measure: Mean change from baseline angle of catch (XV3) Tardieu scale
timeFrame: 20 weeks
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Nigar Dursun
role: STUDY_DIRECTOR
References:
citation: Nguyen L, Di Rezze B, Mesterman R, Rosenbaum P, Gorter JW. Effects of Botulinum Toxin Treatment in Nonambulatory Children and Adolescents With Cerebral Palsy: Understanding Parents' Perspectives. J Child Neurol. 2018 Oct;33(11):724-733. doi: 10.1177/0883073818786567. Epub 2018 Jul 24.
citation: Nguyen L, Mesterman R, Gorter JW. Development of an inventory of goals using the International Classification of Functioning, Disability and Health in a population of non-ambulatory children and adolescents with cerebral palsy treated with botulinum toxin A. BMC Pediatr. 2018 Jan 4;18(1):1. doi: 10.1186/s12887-017-0974-x.
citation: Delgado MR, Tilton A, Russman B, Benavides O, Bonikowski M, Carranza J, Dabrowski E, Dursun N, Gormley M, Jozwiak M, Matthews D, Maciag-Tymecka I, Unlu E, Pham E, Tse A, Picaut P. AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral Palsy: A Randomized Controlled Trial. Pediatrics. 2016 Feb;137(2):e20152830. doi: 10.1542/peds.2015-2830. Epub 2016 Jan 26.
citation: Dursun N, Gokbel T, Akarsu M, Dursun E. Randomized Controlled Trial on Effectiveness of Intermittent Serial Casting on Spastic Equinus Foot in Children with Cerebral Palsy After Botulinum Toxin-A Treatment. Am J Phys Med Rehabil. 2017 Apr;96(4):221-225. doi: 10.1097/PHM.0000000000000627.
citation: Reid SM, Carlin JB, Reddihough DS. Using the Gross Motor Function Classification System to describe patterns of motor severity in cerebral palsy. Dev Med Child Neurol. 2011 Nov;53(11):1007-12. doi: 10.1111/j.1469-8749.2011.04044.x.