This proof-of-principle evaluation aims to investigate whether a home-based balance training using an exergame (HEROES), following a single session of perturbation-based training improves reactive step quality in people with chronic stroke.
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the quality of the reactive stepping response following
perturbations from standstill. The quality will be expressed as the angle of
the stepping leg relative to the vertical at foot contact.
Secondary outcome
- Multiple stepping threshold in the forward and backward direction.
- Spatiotemporal step characteristic (step onset, step duration, step length
and step velocity) and anticipatory step characteristics (forward lean and
weight-bearing assymetry) at the multiple stepping threshold in the forward and
backward direction, as these parameters have the potential to explain the
presence or absence of differences in the primary outcome.
- Clinical outcome measures (Fugl-Meyer Motor Assessment lower extremity
subscale, Trunk Impairment Scale, Mini-BESTest, Functional Ambulation Category,
10-meter Walk Test, Dynamic Gait Index). This standardized core set of post
stroke balance and mobility assessments will be performed according to the
consensus-based recommendations from the Stroke Recovery and Rehabilitation
Roundtable.
Background summary
In people with stroke, reactive stepping responses to recover from a loss of
balance are often impaired, which increases their risk of falling. Adequate
reactive stepping is critical for preventing falls following external balance
perturbations. Perturbation-based training (PBT) has a great potential to
improve reactive stepping performance. However, PBT requires expensive
equipment and supervision, which limits its clinical uptake. Also, it is not
yet possible to perform this type of training in a safe way at home. A
promising solution to fill this gap is training based on action observation and
motor simulation (AOMS) of reactive stepping. Therefore, we developed the
HEROES exergaming intervention based on the principle of AOMS. This approach
sets our intervention clearly apart from any currently available home-based
exergames, which aims at healthy persons and lacks the required
personalization. The ultimate goal is fall reduction in people with stroke
(PwS), but with this evaluation we first aim to proof the principle of the
HEROES (Home-based exergaming for enhancing resistance to falls after Stroke)
intervention in PwS.
Study objective
This proof-of-principle evaluation aims to investigate whether a home-based
balance training using an exergame (HEROES), following a single session of
perturbation-based training improves reactive step quality in people with
chronic stroke.
Study design
Three-arm proof-of-principle evaluation with a randomized design.
Intervention
Participants will randomly be assigned to;
• experimental group A - single training session with real perturbations,
immediately followed by 5 weeks of home-based HEROES exergame training
• experimental group B - single session with real perturbations, followed by 5
weeks of home-based HEROES exergame training after a waiting period of 5-6 weeks
• a control group - no perturbation-based training session and home-based
training with a commercially available game (which is not expected to improve
reactive stepping)
Study burden and risks
BENEFITS
• Experimental groups: Participants in the experimental groups will receive a
single perturbation-based training session followed by home-based training with
virtual balance perturbations with the HEROES exergame. The single PBT session
is expected to improve resilience to postural disturbances and thus possibly
reduce risk of falls. Furthermore, the home-based exergaming period is expected
to result in improved reactive balance control.
• Control group:The control participants will be provided with a commercially
available step game for voluntary instead of reactive step training. Voluntary
step training is expected to not improve reactive stepping performance, but
control participants may benefit from improvements in a variety of physical and
cognitive functions associated with falls, as other studies evaluating
technology-based stepping interventions delivered at home demonstrated.
BURDEN
• Experimental groups: The participants will complete four lab visits (intake
session and pre-intervention, mid-term and post-intervention balance
assessments) over the course of about 12 week, each lasting about 2-3 hours.
The second lab visit contains an additional hour of PBT. In between lab visit 2
and 3 (experimental group A) or lab visit 3 and 4 (experimental group B), the
participants will perform home-based reactive step training 3 times per week
for 30 minutes for 5 weeks in total.
• Control: Similarly to the experimental group, the control participants will
complete four 2-3 hour lab visits (intake session and pre-intervention,
mid-term and post-intervention balance assessments) over the course of about
12 weeks, with no additional hour of PBT. In between lab visit 2 and 3, they
will perform home-based voluntary step training 3 times per week for 30 minutes
for the duration of 5 weeks.
RISKS
• Balance assessments and the additional PBT session: The risks associated with
the balance assessments and the additional PBT session are deemed negligible.
Firstly, these sessions are performed on a CE-certified instrumented treadmill
(GRAIL). Similar use of this treadmill is standard healthcare practice at the
clinical centers involved. Secondly, actual falls and fall-related injuries are
prevented by the safety harness that participants will wear at all time on the
instrumented treadmill. This safety harness which will catch participants when
they lose their balance.
• Home-based training: The risks of falls and fall-related injuries associated
with the home-based step training are deemed negligible as well. Rehabilitation
physicians and physical therapists have concluded at expert panel meetings that
the stepping movements evoked by the game are no more dangerous than normal
steps in everyday life. Furthermore, previous research has shown that step
training at home in elderly and in balance impaired clinical populations
occurred with no adverse events such as falls. Moreover, the risks of the
home-based training were thoroughly discussed with a technical and medical
expert panel and with patients, and these risks were further minimalized
accordingly.
Reinier Postlaan 4
Nijmegen 6525GC Nijmegen
NL
Reinier Postlaan 4
Nijmegen 6525GC Nijmegen
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Age between 18 and 75 years old.
- Have sustained a unilateral stroke in the cerebrum more than 6 months ago.
- Have completed inpatient rehabilitation within the past two years.
- Experiencing mild to moderate impairments in balance and walking.
- Physically able to stand and walk independently (Functional Ambulation
Categories score >=4).
- Living in the community.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Conditions in which physical activity is contra-indicated.
- Conditions in which reactive step training on the GRAIL is contra-indicated.
- Any other neurological or musculoskeletal conditions affecting balance or
gait abilities.
- Impaired vision that is not corrected by glasses or lenses.
- Severe cognitive problems based on the Montreal Cognitive Assessment.
- Persistent visuo-spatial neglect based on the Star-Cancellation Test.
- Use of psychotropic drugs or other medication negatively affecting balance.
- Behavioural problems interfering with compliance to the study protocol.
- Unable to use the intervention system independently.
- Unable to give a personal informed consent.
Design
Recruitment
Medical products/devices used
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 | NL85745.091.23 |