The aim of the present study is to investigate the reproducibility of upper extremity strength measurements in children with CP. The following strength measurement instruments will be studied: Hand Held Dynamometry (HHD), pinch- and grip strength…
ID
Source
Brief title
Condition
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures: the most important psychometric property to
investigate in terms of muscle strength evaluation is reproducibility.
Reproducibility in this study will be assessed by looking at the following
factors: Intraclass Correlation Coefficient (ICC), Limits Of Agreement (LOA),
Standard Error of Measurement (SEM) en de Smallest Detectable Difference (SDD).
Reference values for upper extremity muscle strength in children and
adolescents will be determined by using the Generalized Additive Models for
Location, Scale, and Shape (GAMLSS) method.
Secondary outcome
not applicable
Background summary
Rationale: Sixty percent of the children and adolescents with Cerebral Palsy
(CP) experiences problems with their arm and hand function in daily pursuits.
There is increasing evidence that strength in the affected arm in children with
a unilateral CP is a good predictor for the use of this arm in bimanual
performance. There is also evidence that upper extremity muscle strength in
children with CP, in the affected arm as well as in the non-affected arm, is
less compared to typically developing peers. To be able to evaluate upper
extremity muscle strength in children with CP properly, there is a need for
valid and reliable measurement instruments. A systematic review on psychometric
properties of upper extremity strength measurement instruments showed that
there only a few studies published on this topic and that the methodological
quality of these studies is low.
Study objective
The aim of the present study is to investigate the reproducibility of upper
extremity strength measurements in children with CP. The following strength
measurement instruments will be studied: Hand Held Dynamometry (HHD), pinch-
and grip strength measurements using the E-link system and functional strength
measurements. To study how upper extremity muscle force in children with CP is
related to the upper extremity muscle force of typically developing peers,
these measurements will also be administerd in normal age-matched children.
Study design
Study design: a non-randomised, cross sectional study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The risk of particpating in this study can be
considered very low. The movements these children have to make are not
different from the movement during activities of daily living. HHD and the
E-link system are often used in clinical practice. The functional strength
measurements are similar to activities of daily living , i.e. carrying a crate
(bimanual) and holding a jug (unimanual). The movements pose no harm or risk
to the patient. The burden of participating in this study is alo low. Children
have to invest maximal 3 hours. The burden of the typically developing peers
who are assessed to gather reference data is only 1 hour. The children with CP
can undergo the measurements at the same place where they go to school and
receive their regular therapy, so there is no need for travelling. The
measurements of the typically developing children will be organised in a
similar manner at their school or club.
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
Children with CP:
* child diagnosed with CP, unilateral or bilateral with a clear difference between the left and right side
* age between 7 and 18 years
* GMFCS level I-III
* MACS level I-III
* enough intellectual ability to understand easy tasks
* children and their parents/caregivers should comprehend and speak Dutch;Typically developing children:
* attending regular primary or secondary school
* age between 7 - 18 years
* children and their parents/caregivers should comprehend and speak Dutch
Exclusion criteria
Children withCP:
* surgical intervention < 6 months
* Botulinum Toxin A treatment in the upper extremity in the past 6 months
* Contractures in the upper extremity disturbing functional use;Typical developing children:
* Muscle disease
* Injuries, fractures or casting of the upper extremity in the past 6 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02146989 |
| CCMO | NL45430.068.13 |