Improved Sitting Balance: Body Functions to Participation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Drug: Botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum toxin type A|Injections to hypertonic muscles|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Botulinum Toxin A, Participation