Improved Sitting Balance: Body Functions to Participation

NCT03788317 | Completed DMC

• 1 other identifier: KU GOKAEK 2018/358
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy, Botulinum Toxin A, Participation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Goal Assessment Scale (GAS)

  20 weeks

Other Outcomes (3)

• Gross Motor Function Classification System (GMFCS)

  20 weeks

• Mean change from baseline Modified Ashworth Scale (MAS)

  20 weeks

• Mean change from baseline angle of catch (XV3) Tardieu scale

  20 weeks

Interventions

Botulinum toxin type A DRUG

Injections to hypertonic muscles

Also known as: Botox, Dysport

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Severe cognitive or behavioural problems
• Severe dystonia

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41050, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 30039731 BACKGROUND

• 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.

  PMID: 29301539 BACKGROUND

• 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.

  PMID: 26812925 BACKGROUND

• 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.

  PMID: 27631386 BACKGROUND

• 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.

  PMID: 22014320 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Nigar Dursun

  Kocaeli University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 25, 2018
• First Posted: December 27, 2018
• Study Start: December 28, 2018
• Primary Completion: June 26, 2019
• Study Completion: July 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

TU (1)