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Improved Sitting Balance: Body Functions to Participation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788317
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Nigar Dursun, Kocaeli University

Tracking Information
First Submitted Date December 25, 2018
First Posted Date December 27, 2018
Last Update Posted Date August 21, 2019
Actual Study Start Date December 28, 2018
Actual Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 2, 2019)
  • 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).
Original Primary Outcome Measures
 (submitted: December 25, 2018)
  • The Child and Adolescent Scale of Participation (CASP) [ Time Frame: 20 weeks ]
    Participation measurement
  • The Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) [ Time Frame: 20 weeks ]
    Health Related Quality of Life measurement
Change History Complete list of historical versions of study NCT03788317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 2, 2019)
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
Original Secondary Outcome Measures
 (submitted: December 25, 2018)
Goal Assessment Scale (GAS) [ Time Frame: 20 weeks ]
Functional goal attainment measurement
Current Other Pre-specified Outcome Measures
 (submitted: April 2, 2019)
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: December 25, 2018)
  • Gross Motor Function Classification System (GMFCS) [ Time Frame: 20 weeks ]
    Motor Development
  • Mean change from baseline Modified Ashworth Scale (MAS) [ Time Frame: 20 weeks ]
    Tone measurement
  • Mean change from baseline angle of catch (XV3) Tardieu scale [ Time Frame: 20 weeks ]
    Spasticity measurement
 
Descriptive Information
Brief Title Improved Sitting Balance: Body Functions to Participation
Official Title Integrated Botulinum Toxin for Improved Sitting Balance in Children With Cerebral Palsy: Body Functions to Activity and 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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Cerebral Palsy
Intervention Drug: Botulinum toxin type A
Injections to hypertonic muscles
Other Name: Botox, Dysport
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 20, 2019)
29
Original Estimated Enrollment
 (submitted: December 25, 2018)
30
Actual Study Completion Date July 1, 2019
Actual Primary Completion Date June 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03788317
Other Study ID Numbers KU GOKAEK 2018/358
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Nigar Dursun, Kocaeli University
Study Sponsor Kocaeli University
Collaborators Not Provided
Investigators
Study Director: Nigar Dursun Kocaeli University
PRS Account Kocaeli University
Verification Date August 2019