The aims of the study are 1) to upgrade an existing GA protocol based on inertial system(developed at the INAIL Prostheses Centre in collaboration with the University of Bologna) in terms offinding out which calibration procedures result suitable to…
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome product of the study is the refined protocol to achieve GA
from the IMMS for children with CP. The main measure is the difference in joint
kinematics, measured with the ambulatory system versus the reference
optoelectronic system, expressed in the Root Mean Square difference (RMSd) and
the coefficient of multiple correlation (CMC). The results will be published.
Secondary outcome
Secondary study parameters are
* the study of the reliability of the protocol developed.
* the study of the influence of a laboratory setting on the spontaneous walk of
the patient
Background summary
Cerebral Palsy (CP) is the problem of greatest interest among all child motor
disabilities.
Gait Analysis (GA) is nowadays considered as the most refined tool available
for the documentation
and the functional assessment of the gait, especially in CP children. The GA is
widely used to classify
different forms of CP and to evaluate the effectiveness of rehabilitation
treatments. Optoelectronic
measurements systems are currently the only systems used to obtain GA. However,
such specialized
equipment limits the clinical use of this exam only to dedicated laboratory.
Alternatively, an inertial and
magnetic measurement system (IMMS) can be used. Such systems are increasingly
relevant in
clinical practice but need to be validated on CP children.
Study objective
The aims of the study are 1) to upgrade an existing GA protocol based on
inertial system
(developed at the INAIL Prostheses Centre in collaboration with the University
of Bologna) in terms of
finding out which calibration procedures result suitable to the different kind
of patients with CP, and 2)
to evaluate the validity and the reliability of this protocol with respect to a
reference system and
protocol, in measuring joint kinematics during gait.
Study design
This is a pilot study. Walking trials and measurements will be performed partly
in the gait laboratory of the VU University Medical Center in Amsterdam, the
Netherlands, and partly into a edicated reserved area in the same location. 10
CP children will be measured in a first session using the IMMS and the
reference optoelectronic system to calibrate the systems on the subject*s body;
then they will be measured inside the laboratory to investigate the validity of
hardware and protocol; thirdly, the children will be measured in the reserved
area outside the laboratory to determine the influence on the gait patterns of
the laboratory setting itself; and finally the calibration procedures will be
executed once more inside the laboratory to determine the reliability of the
protocol.
Study burden and risks
Patients will be asked to walk a 10m walkway and a 50m walkway at self-selected
speed, wearing the IMMS sensors and marker clusters attached to the segments of
the lower extremities. The measurements are non-invasive. Markers and inertial
sensors have cables and may somehow increase the burden during the measurements
compared to normal walking. During walking, pain and fatigue could occur,
however, the risk of pain will be minimal. Patients can quit the measurements
if pain will occur. The practical relevance of this study is that validation of
the IMMS in a clinical situation may help to introduce such systems in clinical
practice in order to increase the use of the GA technique and to simplify and
improve its application in CP children.
Postbus 7057
1007 MB Amsterdam
Nederland
Postbus 7057
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Diagnose Cerebral Palsy (hemiplegic or diplegic)
Between 7 and 15 years of age
GMFCS classification I, II or III
Exclusion criteria
- inability to understand the task required
- inability to understand the Dutch, English or Italian language.
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 | NL27647.029.09 |