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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. Identifier: NCT03788317
Recruitment Status : Completed
First Posted : December 27, 2018
Last Update Posted : August 21, 2019
Information provided by (Responsible Party):
Nigar Dursun, Kocaeli University

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.

Condition or disease Intervention/treatment
Cerebral Palsy Drug: Botulinum toxin type A

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.

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Botulinum toxin type A
    Injections to hypertonic muscles
    Other Name: Botox, Dysport

Primary Outcome Measures :
  1. 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.

  2. 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).

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03788317

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Kocaeli University
Kocaeli, Turkey, 41050
Sponsors and Collaborators
Kocaeli University
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Study Director: Nigar Dursun Kocaeli University


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Responsible Party: Nigar Dursun, Professor, Kocaeli University Identifier: NCT03788317     History of Changes
Other Study ID Numbers: KU GOKAEK 2018/358
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nigar Dursun, Kocaeli University:
Cerebral Palsy, Botulinum Toxin A, Participation
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents