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NCT Number: NCT03788317

Improved Sitting Balance: Body Functions to Participation

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli University

Kocaeli, 41050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Injections to hypertonic muscles

Other names: Botox, Dysport

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 27, 2018
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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