The main goal of the VUmc part of the study is to acquire sets of data related to Neurological and Neuromuscular Diseases; in order to build a paediatric digital repository and to develop biophysical modelling and probabilistic modelling.
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For both standard care group and extended measurement group: Standardized
history; 3D Clinical gait analysis (kinematic data; kinetic data; EMG); Walking
oxygen consumption data; and Standard physical exam. For the extended
measurement group only: isometric muscle strength; lower body MRI of bones and
lean tissue. For TD children: 3D clinical gait analysis; for some TD children
also other measurements of the extended protocol.
Secondary outcome
not applicable
Background summary
The EU-funded FP7 project MD-Paedigree aims to create a large-scale European
database for four paediatric disease areas. This database will consist of
clinical data and biophysical modelling outcomes. Biophysical modelling aims to
unravel the pathophysiology of the various diseases. The large database will
allow statistical modelling on large numbers of patients, to allow similarity
searches and individualized treatment prediction.
Study objective
The main goal of the VUmc part of the study is to acquire sets of data related
to Neurological and Neuromuscular Diseases; in order to build a paediatric
digital repository and to develop biophysical modelling and probabilistic
modelling.
Study design
Translational study
Study burden and risks
The measurement will take approximately 5 hours of which 2.5 hours are due to
the extra measurements for the extended group. All measurements will be
performed within one day if possible. If necessary for logistic reasons or if
preferred by the patient and parents/guardians the measurements can be split
into two separate sessions, one at the dept. of rehabilitation medicine and one
at the dept. of radiology, with a maximum of one week in between the two
sessions. The measurements will be combined with standard clinical care
measurements, if possible. The actual MRI measurement will take approximately 3
times 7 minutes scan time.Lying still for this amount of time might be
burdensome for some children.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
- Aged between 6 and 15 years (8-15 for the extended measurements for CP children)
- Parent/guardian consent
- Sufficient cognitive skills: able to follow simple instructions;For patient group only:
- Children with a diagnosis of Cerebral Palsy following the definition of Rosenbaum: *Cerebral Palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non progressive disturbances that occurred in the developing foetal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour, by epilepsy, and by secondary musculoskeletal problems*
- GMFCS level I-II. (gross motor function classification system)
- Spastic cerebral palsy
Exclusion criteria
- Patient history of functional surgery on bones and/or muscles of the legs; selective dorsal rhizotomy (not during follow up for the standard usual care group)
- Lower limbs BoNT A injection in the last 6 months (not during follow up for the standard usual care group)
- Patient history of hip, backbone and/or lower limb fracture;
- Relevant visual deficit;
- Behavioural problems of an extent that they can impede normal subject cooperation
- Significant comorbidities
- Claustrophobia.
- A pacemaker or other non-removable metal-containing devices or objects
- Not able to lie still for 3 times 7 minutes
- Not willing to hear about *incidental findings*, potential unforeseen, clinically relevant abnormalities found in the MRI images.
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 | NL48494.029.14 |