Protocol optimization for the GAITRite in m.3243A>G carriers
ID
Source
Brief title
Condition
- Metabolic and nutritional disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The paramaters calculated by the GAITRite
Secondary outcome
Muscle power mm. quadriceps
3 min walking test
Berg Balance Scale
Balance (forceplatform)
Background summary
There is a quest for sensitive outcome measures for clinical trials in
m.3243A>G carriers, the most frequent mutation of mtDNA.
Gait abnormalities are frequently reported by patients carrying the m.3243A>G
mutation.
Tthe group from Newcastle reported abnormal gait in a small cohort of m.3243A>G
carriers using the GAITRite
Study objective
Protocol optimization for the GAITRite in m.3243A>G carriers
Study design
Observational study with non invasive measurements testing 3 different
protocols and their test-retest reliability and deviation from healthy controls
Study burden and risks
Limited burden
No risk
Large grouprelatedness since this study is a preparation for the phase 2 trial
in this population.
Geert grooteplein noord 10
Nijmegen 6500 HB
NL
Geert grooteplein noord 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Carrier of the m.3243A>G mutation
Older than 18 years;Healthy = no conditions leading to abnormal gait (orthopedic, neurological or neuromuscular disorders)
Exclusion criteria
Orthopedic problems interfering with gait
Not able to walk for 3 minutes
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 | NL56121.091.15 |