Improved Sitting Balance: Body Functions to Participation

Cerebral Palsy Clinical Trial

Official title:

Integrated Botulinum Toxin for Improved Sitting Balance in Children With Cerebral Palsy: Body Functions to Activity and Participation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788317
• Other study ID #: KU GOKAEK 2018/358
• Status: Completed
• Start date: December 28, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2019
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 1, 2019
• Est. primary completion date: June 26, 2019
• 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

• 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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Drug:
• Botulinum toxin type A
Injections to hypertonic muscles

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gross Motor Function Classification System (GMFCS)	Motor Development The gross motor skills (e.g. sitting and walking) of children and young people with cerebral palsy can be categorised into 5 different levels from I to V using a tool called GMFCS.	20 weeks
Other	Mean change from baseline Modified Ashworth Scale (MAS)	Tone measurement Scoring 0= No increase muscle tone; 1= Slight increase in muscle tone, manifested by a catch and release or by minimal resislance at the end of the range of motion when the affected part (s) is moved in flexion or extension; 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 =More marked increase in muscle tone through most of the ROM, but affected part (s) easily moved; 3 =Considerable increase in muscle tone, passive movement difficult; 4 =Affected part (s) rigid in flexion or extension.	20 weeks
Other	Mean change from baseline angle of catch (XV3) Tardieu scale	Spasticity measurement Degree of anle of catch is measured baseline and after treatment to define the change from baseline	20 weeks
Primary	The Child and Adolescent Scale of Participation (CASP)	Participation measurement The CASP consists of 20 ordinal-scaled items and four subsections: 1) Home Participation 2) Community Participation 3) School Participation and 4) Home and Community Living Activities The 20 items are rated on a four-point scale: Age Expected (Full participation) to Unable.	20 weeks
Primary	The Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)	Health Related Quality of Life measurement The CPCHILD© Questionnaire measures the caregiver's perspective about the child's health status, comfort, wellbeing, functional abilities and ease of caregiving. It is a useful proxy measure of health related quality of life of children with severe disabilities.; Basic Scoring Procedure Scores for each domain and for the total survey are standardized and range from 0 (worse) to 100 (best).	20 weeks
Secondary	Goal Assessment Scale (GAS)	Functional goal attainment measurement GAS 5-Point Rating Scale Score Predicted Attainment; (-2)Less than expected outcome; (-1) Expected outcome after intervention; (0)Much less than expected outcome; (+1) Greater than expected outcome; (+2) Much greater than expected outcome	20 weeks