*Evaluate our current measurement procedure (*UX analysis report*), that objectively and accurately records the 3D movement of the UX, in healthy children to establish norm values, normal variation and reproducibility in children*Test whether the UX…
ID
Source
Brief title
Condition
- Other condition
- Movement disorders (incl parkinsonism)
Synonym
Health condition
Obstetric Brachial Plexus Lesion (OBPL)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
*3D kinematics and variation and specific parameters which can only be
determined after the study with the patients is completed. Then we can detect
where the 3D kinematics of the patients differ from the healthy population and
translate this into specific parameters.
Secondary outcome
not applicable
Background summary
The VUmc is one of the three centers of excellence in the Netherlands on
offering specialized multidisciplinary treatment for children with Obstetric
Brachial Plexus Lesion. In severe cases a plexus recontruction will be done a
few months after birth (primary surgery). When a child reaches the age of four
and the functional use of the affected arm is still limited, secondary surgery
will be considered, such as muscle and tendon transfers.
The decision to perform a certain surgical procedure is currently mainly based
on the clinical expertise and experience of the surgeon and physiatrists.
However, current clinical assessment methods are insufficient to predict and
evaluate optimal treatment. Joint ROM (Range of Motion) and qualitative
observation of activities, are not sufficient to describe actual (dys)function
and are unable to distinguish between primary (loss of muscle control and/or
power) and secondary (compensatory movements) consequences of the disease.
Therefore, to evaluate functional effects and make it accessible for further
research, there is a need for an objective, quantitative method, which includes
intersegmental coordination and the analysis of these motions in 3D. In a pilot
study we developed a measurement protocol for the kinematic evaluation of the
upper extremities (UX) of healthy adults. The aim of the current study is to
develop and apply this measurement protocol for kinematic evaluation of the UX
of healthy children and children with OBPL.
Study objective
*Evaluate our current measurement procedure (*UX analysis report*), that
objectively and accurately records the 3D movement of the UX, in healthy
children to establish norm values, normal variation and reproducibility in
children
*Test whether the UX analysis report adequately distinguishes UX movement in
pre-operative OBPL children compared to the norm values
*Test whether shifts from pre- to postoperative values can be distinguished by
the UX analysis report as moving towards norm values
Study design
Observational study to compare groups:
*Cross-sectional: OBPL children with indication for secondary surgery compared
to healthy children
*Longitudinal: OBPL patients before and after secondary surgery
Study burden and risks
The extensive kinematic data of the UX movements that will be collected, will
give a better quantitative understanding of movement deviations as opposed to
regular clinical examination. In the future, this additional data is expected
to lead to better diagnosis and treatment. The development of gait analysis has
been extremely useful in the treatment of lower extremity dysfunctions.
Likewise, analysis of UX functions by means of 3D kinematics has the potential
to become an important tool in clinical decision-making and therapeutic
evaluation of patients with UX disorders.
The additional risks of the current study for the subjects are negligible and
the burdens minimal. The measurements are non-invasive. Subjects will be
sitting on a stool with movement sensors attached to their upper bodies. Most
patients will be familiar with the movements because many of these are standard
in clinical examinations. The kinematic movement sensors and the straps that
will be used to attach them, will be a new situation for the children, as well
as the fact that they will be connected to the computer with a cable that is
necessary for data collection. From our gait analysis experience, it is known
that children comply with this measurement technique. Parents/guardians and
children will be informed about the measurement procedures and tools beforehand
so that they will be prepared for this, and that they will know about any
possible burdens.
We believe the benefits clearly outweigh the risks or burdens for the subjects.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients:
Clinical diagnosis of Obstetric Plexus Brachial Lesion
Age: between 4 and 12 years of age
male and female;Healthy controls:
age: 4-7 and 8-12 years
male and female
Exclusion criteria
Patients:
- Additional disorders (other than OPBL) that influence the child's movement pattern of the upper extremities
- Parents or guardians and child do not understand the Dutch or English language well enough to take part in this project;Healthy controls:
- Any (known) deviation that may influence movements of the upper extremities
- Parents or guardians and child do not understand the Dutch or English language well enough to take part in this project
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 |
---|---|
CCMO | NL12553.029.06 |