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Model-Driven Paediatric European Digital Repository (MD-Paedigree)

Model-Driven Paediatric European Digital Repository (MD-Paedigree) - MD-Paedigree

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42159
Enrollment
30
Registered
2014-08-11
Start date
2015-01-22
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral palsy

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)