Improved Sitting Balance: Body Functions to Participation
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|ClinicalTrials.gov Identifier: NCT03788317|
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment|
|Cerebral Palsy||Drug: Botulinum toxin type A|
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.
|Study Type :||Observational|
|Actual Enrollment :||29 participants|
|Official Title:||Integrated Botulinum Toxin for Improved Sitting Balance in Children With Cerebral Palsy: Body Functions to Activity and Participation|
|Actual Study Start Date :||December 28, 2018|
|Actual Primary Completion Date :||June 26, 2019|
|Actual Study Completion Date :||July 1, 2019|
- Drug: Botulinum toxin type A
Injections to hypertonic musclesOther Name: Botox, Dysport
- The Child and Adolescent Scale of Participation (CASP) [ Time Frame: 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) [ Time Frame: 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).
- Goal Assessment Scale (GAS) [ Time Frame: 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
- Gross Motor Function Classification System (GMFCS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 20 weeks ]Spasticity measurement Degree of anle of catch is measured baseline and after treatment to define the change from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788317
|Kocaeli, Turkey, 41050|
|Study Director:||Nigar Dursun||Kocaeli University|