The aim of this study is to optimize the protocol for gait analysis for children with mitochondrial diseasesSecundary- feasibility- reliability- reliability after exercise- compare with healthy controls- reference values for children
ID
Source
Brief title
Condition
- Metabolic and nutritional disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Parameters of gait
Secondary outcome
3 minute walking distance
Background summary
Gait is an emerging end point for clinical studies, which will be used in a
phase 2 trial in adults at our centre. To prepare for future paediatric
studies, we aim to determine whether gait, measured by the GAITRite is also a
feasible and reliable end point for children.
Study objective
The aim of this study is to optimize the protocol for gait analysis for
children with mitochondrial diseases
Secundary
- feasibility
- reliability
- reliability after exercise
- compare with healthy controls
- reference values for children
Study design
OBservational study
Study burden and risks
The test is not burdensome and combined with an outpatient visit.
Precautions are taken when the child has a high likelihood of falls
Geert grooteplein noord 10
Nijmegen 6500 HB
NL
Geert grooteplein noord 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Patients:
- aged 1-18 years
- genetically confirmed mitochondrial disease
- able to walk 3x10 meters; five times;Healthy controls
Aged 1-18 years
able to walk
no neurological, orthopedic or neuromuscular disease influencing gait
Exclusion criteria
- Ernstige gedragsproblemen
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 | NL58062.091.16 |