The primary objective of this study is to determine whether 3D kinematics, kinetics and spatiotemporal parameters during walking on the V-Gait system are comparable to overground walking in children with cerebral palsy and in healthy children…
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are spatiotemporal variables, kinematics and kinetics
during gait.
Secondary outcome
The secondary study parameter is subjective experience of the subjects in the
different conditions.
Background summary
Gait analysis is a frequently used tool to precisely assess the gait-pattern
deviations in children with Cerebral Palsy (CP). Gait analysis is typically
performed in a gait laboratory in which a patient walks up and down a 5 to 10
meter walkway while muscle activity, kinetic and kinematic data are collected.
Although valuable data are collected during an overground gait analysis, there
are limitations. Only a few steps can be measured because patients need to
speed up and slow down, and patients only have a few chances to hit the force
plate. The new V-Gait system, based on treadmill, allows for continuous
measurement during walking which makes it possible to take many steps per
trial. The V-Gait system could thus potentially replace the gait lab while
decreasing patients load and greatly enhancing the number of possible
applications.
Study objective
The primary objective of this study is to determine whether 3D kinematics,
kinetics and spatiotemporal parameters during walking on the V-Gait system are
comparable to overground walking in children with cerebral palsy and in
healthy children between the age of 8-16 years.
Secondary objectives are to determine the necessity of the V-Gait components:
self-paced speed and virtual reality on gait parameters; and to determine
whether the effect of V-Gait walking is different in children with CP compared
to typically developing children.
Study design
This is a Cross-sectional experimental study. The measurements will be
performed in the gait laboratory of the VU Medical Centre in Amsterdam.
Study burden and risks
The study is carried out with minors. They will be asked to walk overground in
the gait laboratory and on a treadmill with a virtual reality screen around
them. The burden is minimal and the risks negligible because the overground
walking as performed in the gait laboratory is identical to standard clinical
tests as routinely performed. While walking on the V-Gait system, they are kept
in a safety harness to remove the minimal risk of falling or stumbling off the
treadmill. In a 2 hour session the subjects have to walk for a total of ~30
minutes, interrupted by resting pauses. Only children will be selected that are
capable of doing so, so that the measurements will not impose any burden more
than regular daily-life activities.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
All children with CP:
- must have a clinical diagnosis of CP,
- are aged between 8 and 16 years,
- are diplegic or hemiplegic,
- are able to walk independently without walking aids (GCMAS level I-II. gross motor function classification system, (Wood and Rosenbaum, 2000)),
- are able to walk (shod, with AFO if needed) for a total of at least 30 minutes in a 2h time span and 5 minutes on end,
- and can be both male or female;All typically developing children:
- are age matched and sex matched with the CP children.
Exclusion criteria
Children with CP will be excluded when:
- multilevel surgery has taken place less than 1 year prior participation,
- SDR or intrathecale baclophen (ITB) treatment has taken place less than 1 year prior to participation
- a BTX-A treatment has been given less than 16 weeks prior participation,
- the child*s movement pattern is mainly dyskinetic / ataxic,
- there are additional disorders (other than CP) that influence gait or
- parents or guardians and child do not understand the Dutch or English language well enough to take part in this project
Typically developing children will be excluded when:
- there are any (known) deviations that may influence gait or
- parents or guardians and child do not understand the Dutch or English language well enough to take part in this project.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL38838.029.11 |