NCT03788317

Improved Sitting Balance: Body Functions to Participation

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Kocaeli University · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A	Injections to hypertonic muscles

Timeline

• Start date: 2018-12-28
• Primary completion: 2019-06-26
• Completion: 2019-07-01
• First posted: 2018-12-27
• Last updated: 2019-08-21

Locations

1 site across 1 country: Turkey (Türkiye)