Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, Botulinum Toxin A, Participation
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.
Interventions
DRUGBotulinum toxin type A
Injections to hypertonic muscles
Sponsors
Kocaeli University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Child and Adolescent Scale of Participation (CASP) | 20 weeks | 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. |
| The Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) | 20 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goal Assessment Scale (GAS) | 20 weeks | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Classification System (GMFCS) | 20 weeks | 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. |
| Mean change from baseline Modified Ashworth Scale (MAS) | 20 weeks | Tone measurement Scoring 0= No increase muscle tone; 1= Slight increase ın 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. |
| Mean change from baseline angle of catch (XV3) Tardieu scale | 20 weeks | Spasticity measurement Degree of anle of catch is measured baseline and after treatment to define the change from baseline |
Countries
Turkey (Türkiye)
Outcome results
None listed