Primary Objective: 1) To compare gait adaptability findings as assessed on an instrumented treadmill with projected obstacles and stepping targets (C-Mill) in polio survivors with those of healthy controls. Secondary Objectives:2) To determine theā¦
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome for this study is gait adaptability. Measures of gait
adaptability that will be evaluated are:
1) Anticipatory and reactive obstacle avoidance performance (%), quantified as
the percentage of successfully avoided obstacles during obstacle crossing while
walking on the C-Mill.
2) Stepping accuracy of walking on regular or irregular patterns of stepping
targets (mm), quantified in terms of the variation in foot placement relative
to the stepping targets while walking on the C-Mill.
3) Gait stability during obstacle crossing and visually guided stepping,
quantified in terms of the medio-lateral and backward margins of stability
(MoS).
Secondary outcome
Secondary study outcomes include: step length, step width, and step frequency
during obstacle crossing and visually guide stepping; and balance skills (Timed
up and go test and Berg Balance Scale), balance confidence (Activities specific
Balance Confidence scale), fear of falling (Falls Efficacy Scale), and fall
rate (falls questionnaire).
Background summary
Accidental falls are a major problem for aging polio survivors, especially for
those suffering from post-polio syndrome. Because most falls in polio result
from a trip, a slip, or a misplaced step while walking, gait adaptability is
likely to be an important determinant of the risk of falls. Gait adaptability
is defined as the ability to adapt one*s gait to environmental circumstances,
such as obstacles, stepping targets and cluttered terrains. This
multidimensional nature of gait adaptability may be a key reason why it is so
difficult to measure in clinical practice. Most tests aimed at capturing
aspects of gait adaptability, quantify overall success and time taken, rather
than how the adaptations are achieved. Insight in how gait adaptations are
achieved is needed to help develop rehabilitation interventions that aim to
improve gait adaptability in polio survivors, which, in turn, may reduce the
risk of falling. In addition, insight into the course of gait adaptability is
important for the development of fall programs in these patients. In this
study, we aim to assess the feasibility of an instrumented treadmill with
projected visual obstacles and stepping targets (C-Mill) as a tool to provide
quantitative in-depth information on gait adaptability and its course over time
in polio survivors.
Study objective
Primary Objective:
1) To compare gait adaptability findings as assessed on an instrumented
treadmill with projected obstacles and stepping targets (C-Mill) in polio
survivors with those of healthy controls.
Secondary Objectives:
2) To determine the relation between gait adaptability findings with clinical
measures of balance in polio survivors.
3) To assess changes in gait adaptability over a follow up period of two years
in polio survivors.
4) To investigate the reproducibility of C-Mill gait adaptability assessment in
polio survivors.
Study design
Prospective cohort study with four measurements in two years. Measurements will
be performed at baseline (T1), and after 2 weeks (T2), 12 months (T3) and 24
months (T4). Measurements in healthy controls will only be performed at T1.
Study burden and risks
At study entry, patients will undergo a gait adaptability assessment, muscle
strength assessment, balance testing and fall rate assessment. This will take
approximately 2 hours in total. Healthy subjects will only undergo an
assessment of gait adaptability. At 12 and 24 months follow up, patients will
be reassessed for gait adaptability, muscle strength, balance skills, and fall
rate (2 hours per visit).
Risks for subjects undergoing the gait adaptability assessment are minimal.
While there are no direct benefits to the participants, the findings can be
used to more accurately obtain information on gait adaptability and the course
of gait adaptability in aging polio survivors. This can guide fall
interventions programmes aimed at reducing (accidental) falls in polio and
encourage further research into new evidence based treatment in this area.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patients:
-confirmed history of paralytic poliomyelitis;
-age between 18 and 80 years;
-at least walking indoors without walking aids;
-at least one fall reported in the past year., Control subjects:
-age between 18 and 80 years.
Exclusion criteria
Patients and control subjects:
-other pathologies/co-morbidities directly associated with increased fall risk
such as: vestibular pathology, peripheral neuropathy and Parkinson's Disease.
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 | NL57445.018.16 |