In a cohort of people after a minor stroke, we aim to investigate whether aforementioned balance tests are sensitive enough to detect subtle balance impairments. Secondly, we will investigate whether fall rates differ between people after a minor…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the balance capacity in people in the chronic phase after a minor
stroke, we will conduct a feet-in-place test, stepping test and step adjustment
test on the N-Mill-DFP (treadmill with perturbation and measurement options).
In the intervention study, the balance capacity of participants will be
assessed pre and post intervention. With regard to the cohort and intervention
study, the main study parameters are the Frequency Response Function (FRF;
feet-in-place test), the leg angle at stepping foot contact (stepping test) and
the foot placement error (step adjustment test). For the cohort study, also the
number of falls as registered during the one year follow-up will also be
included as main study parameter.
Secondary outcome
With regard to the cohort and intervention study:
The secondary study parameter for the feet-in-place test include a human
balance control model which is fit onto the experimentally derived FRF, to
estimate parameters with a physiological meaning, for instance ankle joint
passive stiffness, reflexive properties and neural time delay.
The secondary study parameters in the stepping test are the spatiotemporal step
variables (i.e. step onset, step length, step duration, step velocity).
Furthermore, for stepping in medial lateral direction, the percentage of side
steps will be included as study parameter.
For the step adjustment test, onset latencies of stepping adjustments and
average speed of adjustments will be calculated as secondary study parameters.
Other secondary study parameters are the scores on the clinical assessment
(i.e. Montreal Cognitive Assessment, Motricity Index, Fugl Meyer Lower
Extremity Assessment, 10 meter walking test, Activities-specific Balance
Confidence scale, Star Cancellation Test and balance test (Mini-BESTest or Berg
Balance Scale)) and body sway and reaction forces for unperturbed standing
(eyes open and closed). In addition, the daily activity level will be included
as secondary parameter.
Background summary
People after stroke are at a high risk of falls. Impaired balance and gait are
important risk factors for a fall in this population. This makes falls and fall
prevention of utmost importance for every person involved in stroke care.
Currently, balance assessment in clinical settings depends on performance-based
tests. These tests do not provide insight into the neurophysiological
mechanisms underlying impaired balance, have substantial ceiling effects and
are hence insensitive to detect more subtle impairments which still have
tremendous impact on functioning in more advanced activities as in daily
living. In recent years, several promising experimental tests have been
developed that focus on various aspects of our balance capacity. In two of
these tests mechanical perturbations during standing were applied to study
someone*s feet-in-place responses and stepping responses. In addition, for safe
ambulation it is also important to be able to flexibly adjust foot placements
in response to environmental demands. This ability can be tested with a step
adjustment test. Yet only preliminary evidence suggests that these tests can
reveal the underlying mechanisms involved in impaired balance. Stepping
responses and step adjustments have previously been used to distinguish people
after stroke from healthy controls. However, currently it is still unknown
whether the feet-in-place test, stepping test and step adjustment test are also
sufficiently sensitive to detect very subtle balance impairments after a minor
stroke. Furthermore, previous research has shown that these balance tests were
sensitive to evaluate training effects in people after stroke. Despite proven
sensitivity, the specificity of test outcomes to various types of training
provided is still unknown. More insight in these aspects is definitely needed
to determine whether the feet-in-place test, stepping test and/or step
adjustment test provide additional information (compared to clinical tests)
that is necessary for further improvement and individualization of stroke care.
Study objective
In a cohort of people after a minor stroke, we aim to investigate whether
aforementioned balance tests are sensitive enough to detect subtle balance
impairments. Secondly, we will investigate whether fall rates differ between
people after a minor stroke and healthy controls. Furthermore, in a group of
people with stroke with moderate impairments, we aim to investigate whether the
outcomes on the tests are specific for the type of dynamic balance training
provided.
Study design
This project will include two studies: 1) a cohort study and 2) an intervention
study designed as an open-label randomized-controlled study.
Intervention
During the intervention study, participants will be randomized in one of the
three interventions; two interventions consist of dynamic balance training on
the C-Mill/3NP (treadmill) and one intervention consist of no training
(Inactive Control intervention). Participants will receive dynamic balance
training during training sessions of 60 minutes, two times a week, during 5
weeks. Dynamic balance training will consist of walking on the C-Mill/3NP with
augmented visual context (Visual Perturbed intervention) or walking on the
C-Mill/3NP with mechanical perturbations (Mechanical Perturbed intervention).
The level of difficulty will be increased each session based on a fixed
individualized protocol.
Study burden and risks
Benefit: Participants in the cohort study will not directly benefit from
participation in the study. Participants in the intervention study will
possibly receive dynamic balance training. This is expected to translate into
improved balance. However, 20 out of 60 participants will not receive training.
Information gained from both studies will enhance our understanding of the
underlying mechanisms involved in balance in people after stroke and healthy
controls.
Burden: Participants in the cohort study will have a balance assessment of two
hours. During a one-year follow-up period, daily activities will be monitored
four times during a period of one week. In addition, participants will be asked
to fill in a fall calendar. Participants in the intervention study will have a
pre intervention balance assessment similar to the balance assessment of the
cohort study. After the pre intervention balance assessment, daily activity
levels will be monitored during one week. In the following 5 weeks, they will
receive a training session of one hour, twice a week (except for participants
receiving the Inactive Control intervention), resulting in 10 training hours.
After the intervention period, participants will perform a post intervention
balance assessment, which is similar to the balance assessment of the cohort
study. Daily activity levels will also be monitored during one week after the
post intervention balance assessment.
Risks: In recent studies, similar balance tests have been performed without
occurrence of adverse events. The main risk to consider is that participants
lose their balance during the balance assessment or training on a treadmill.
However, falling is prevented by a safety harness.
Reinier Postlaan 2
Nijmegen 6525 GC
NL
Reinier Postlaan 2
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in the cohort study as a participant that had a stroke, a participant must meet the following criteria:
- Having sustained a unilateral minor supratentorial stroke more than 6 months ago with hemiparesis involving the leg.
- Consequences of the stroke were not severe enough to get inpatient rehabilitation in a rehabilitation center.
- Having the capacity to stand and walk *independently* as defined by a Functional Ambulation Categories scores 4 or 5.
- 18 years or older.;In order to be eligible to participate in the cohort study as a healthy participant, a participant must meet the following criteria:
- Not having sustained a stroke.
- Having the capacity to stand and walk *independently* as defined by a Functional Ambulation Categories score 5.
- 18 years or older.;In order to be eligible to participate in the intervention study, a participant must meet the following criteria:
- Having sustained a unilateral supratentorial stroke more than 6 months ago with hemiparesis involving the leg.
- Consequences of the stroke were severe enough to get inpatient rehabilitation in a rehabilitation center.
- Having the capacity to stand and walk *independently* as defined by a Functional Ambulation Categories scores 4 or 5.
- 18 years or older.
Exclusion criteria
With regard to the cohort and intervention study, a potential participant who meets any of the following criteria will be excluded from participation:
- Any other neurological or musculoskeletal conditions affecting balance.
- Current orthopaedic problems; current hip or knee replacement, or limb amputation.
- Severe cognitive problems (Montreal Cognitive Assessment < 26).
- Persistent visuo-spatial neglect (Star-Cancellation Test <= 50) .
- Use of psychotropic drugs or other medication negatively affecting balance.
- Behavioural problems interfering with compliance to the study protocol.
- Unable to stand for 15 minutes without orthosis or walking aid.
- Pregnancy.
- Unable to give a personal consent.;With regard to the intervention study, a potential participant who meets any of the following criteria will also be excluded from participation:
- Conditions in which physical exercise is contra-indicated.
- Unable to walk for 10 minutes without walking aid.
- Receiving physiotherapy focusing on balance or gait which cannot be cancelled during participation in this study, except for participants receiving the Inactive Control intervention. (These participants do not have to cancel usual physiotherapy focusing on balance or gait during participation in this study).
- Having received dynamic balance training with visual and/or mechanical perturbations beforehand.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL53300.091.15 |
| OMON | NL-OMON27894 |