Aim: 1) To continue studying (the determinants of) the decline in functioning in the domains neurological deficits, physical functioning, mental health, social functioning and general health in the first 9 years after the diagnosis, and 2) to study…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In addition to the core set of functional outcome measures and HR-QoL measures
of the FuPro-study (needed to answer research question 1) instrumental measures
and clinical performance tests of gait, energy consumption, muscle strength,
muscle coordination, spasticity, somatosensory signs, visual symptoms, and
postural stability will be performed.
Secondary outcome
not applicable
Background summary
In the course of multiple sclerosis a substantial part of the patients will
experience a decline in several domains of functioning. In the first 5.5 years,
we observed a steady decline in mobility, which is related to impairments of
the pyramidal, cerebellar and sensory tract, and energy levels.
Study objective
Aim: 1) To continue studying (the determinants of) the decline in functioning
in the domains neurological deficits, physical functioning, mental health,
social functioning and general health in the first 9 years after the diagnosis,
and 2) to study the relationships between neurological and physical
impairments, gait characteristics, and walking ability.
Research Questions:
1. What is the longitudinal course of functioning in the domains neurological
deficits, physical functioning, mental health, social functioning and general
health in MS patients during the first 9 years after definite diagnosis?
2. Which gait characteristics and muscle coordination patterns are present 9
years after definite diagnosis of MS?
3. How do neurological and physical impairments (pyramidal, cerebellar and
sensory tract, and energy levels) relate to these gait characteristics and
muscle coordination patterns?
4. How do these gait characteristics and coordination patterns relate to the
walking ability?
5. Which compensatory or adaptive strategies do (subgroups of) patients with MS
use to reduce gait limitations and improve walking ability?
Study design
1) Longitudinal study: extending the follow-up of an inception cohort of 156
patients with MS (FuPro-study, follow-up until 5.5 years after diagnosis) with
a measurement nine years after diagnosis. 2) Cross-sectional study: in-depth
analyses of neurological and physical impairments, analysis of gait
characteristics, and their relationships with walking ability.
Study burden and risks
Total burden of the measurements will be 6 hours (3 parts of 2 hours).
Risks will be minimal
Postbus 7057
1007 MB Amsterdam
NL
Postbus 7057
1007 MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Participants of the FuPRO-MS I study. Patients with recent MS were recruited in 1998-2000. This study concerns the 9-year follow-up measures of the inception cohort.
Exclusion criteria
not applicable
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 | NL20264.029.07 |