Improved Sitting Balance: Body Functions to Participation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-28

Study Completion Date

2019-07-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Botulinum toxin type A

Injections to hypertonic muscles

Intervention Type DRUG

Other Intervention Names

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Botox, Dysport

Eligibility Criteria

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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