We aim to establish an essential step towards evidence-based and individually tailored gait rehabilitation in patients with HSP using the following objectives: 1. This study aims to identify the effect of ten 1-hour sessions C-mill training on gait…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gait adaptability, as measured with the obstacle subtask of the Emory
Functional Ambulation Profile (EFAP).
Secondary outcome
The secondary study parameters are the number of falls and the scores on the 10
meter walk test, 6min walk test and ladder gait test.
In addition we will investigate whether individual improvement in gait
adaptability as measured with the Mini-BEST test is statistically related to
individual balance capacity, more than to lower extremity muscle strength or
muscle tone. Furthermore, we will measure physical activity in daily life by
wearable sensors.
Background summary
Hereditary spastic paraplegia (HSP) is a relatively common, slowly progressive
movement disorder that seriously impacts on gait capacity. Patients with HSP
experience incremental muscle stiffness, muscle weakness and balance problems
and, as a consequence, increasing difficulties to adjust their gait pattern to
changing environmental demands, for instance when avoiding obstacles or
negotiating steps. This is a major problem as such *gait adaptability* is
critical for independent and safe mobility in daily life. Impaired gait
adaptability will also result in falls and fall-related injuries and reduce
quality of life. Therefore, there is an urgent need for evidence-based
rehabilitation interventions to improve gait adaptability in patients with HSP.
Currently, it is unknown whether task-specific training is effective to improve
gait adaptability in patients with HSP.
Study objective
We aim to establish an essential step towards evidence-based and individually
tailored gait rehabilitation in patients with HSP using the following
objectives:
1. This study aims to identify the effect of ten 1-hour sessions C-mill
training on gait adaptability in patients with pure HSP.
2. This study aims to identify the key determinants of C-mill training efficacy
in patients with pure HSP
Study design
A block-randomized intervention study.
Intervention
The intervention group will receive a 5-week C-mill, whereas the control group
will first enter a 5-week waiting period of usual care, after which they
receive the same 5-week C-mill training. Before and after the intervention,
physical activity during daily life will be recorded by activity monitors. Both
groups will be followed up for 15 weeks before and after the training has been
completed.
Study burden and risks
The risk associated with participation will be negligible, according to the
risk classification of the NFU. Burden associated with the measurements will be
limited, as the number of measurements, three or four, will be relatively low.
Since the participants will receive training on gait adaptability, participants
may even benefit from the study. The C-Mill training is provided by a
physiotherapist with C-Mill certification. This can be a physical therapist in
the current environment of the participant.
Reinier Postlaan 2
Nijmegen 6525 GC
NL
Reinier Postlaan 2
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of pure HSP based on molecular diagnosis (e.g. SPG-4 mutations) or
based on inheritance.
- Age between 18 and 70 years old.
- Being able to independently walk barefoot on a level ground for 50 meters
without a walking aid (use of orthopaedic devices or made-to-measure footwear
is allowed).
Exclusion criteria
-Other neurological or serious orthopaedic or psychiatric co-morbidity as well
as previous surgical interventions of the lower extremities.
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 | NL70295.091.19 |