BALANSEAT
RCT study on seated balance training with the Balanseat device in older people

The fall incidence in the elderly increases with increasing age and can lead to
harmful consequences and even premature death. Reduced motor control while
walking, such as reduced trunk and pelvic rotation is a common gait impairment
among the elderly and is considered a risk-factor for falls. Exercise regimens
that target pelvis and trunk rotation are effective in reducing falls among
seniors. However, adherence to exercise therapy is often insufficient, because
elderly people often find the exercises too difficult, they feel insecure or
the usefulness of doing exercises is not recognized. Moreover, elderly people
with mobility problems may find it difficult to visit a therapist and also
depend on when the therapist is available. Exercise in a relaxed, seated
position such as with Balanseat may enhance adherence, especially among
individuals with balance disorders. In settings with limited resources, the use
of such technology may also provide a cost-effective approach for training.
The Balanseat (Mopair Technologies, Ltd., Givat Nili, Israel) is a
thoraco-pelvic assisted exercise device (CE certified) in which the participant
is seated comfortably and safely. The advantage of the Balanseat is that
previous experiences indicated that participants found exercising with the
Balanseat pleasant, secure and of no burden. The Balanseat scientific
background on improving balance and gait is based on two concepts; The
mechanical concept reflects exertion of a passive movement in a specific plane
that may increase the ability of relevant joints to pass through a
predetermined range of motion. Additionally, the motor control concept assumes
that the device increases the sensory feedback from the mechano-sensory
afferents to improve the dynamic control of the movement.
The earlier study on the Balanseat did not study therapy adherence and used a
pre-post-test design without a control group in a small sample size. Hence, we
propose this controlled intervention study to evaluate the true effects of the
Balanseat on therapy adherence, gait and balance compared to usual daily
activity in an elderly population in the Netherlands.

The main objective of the proposed study is to evaluate if the Balanseat (used
as intended) is feasible when only minor involvement from a therapist is
required, contributes to therapy adherence and improves gait and balance
compared to usual daily activity.
The second objectives are;
- evaluate the effect of the Balanseat intervention on mobility as assessed in
daily life by using mobility features derived from data collected with the
GoSafe device activity tracker (Philips Lifeline, Framingham MA, USA) that
reflect (general mobility, quality and quantity of walking and of chair rises)
to obtain insights in the daily life mobility of the study population.

Randomized controlled study

one group receives 15 minutes of exercise with the Balanseat (used as
intended), twice a week, over 6 weeks (total of 12 sessions) and are given
regular advice on healthy lifestyle (eg. staying active and eating healthy),
the control group are given regular advice on healthy lifestyle. Both groups
will be wearing the GoSafe and will receive information on the purpose and
wearing instructions.

No burden en no risks.
Sessions with the Balanseat take 15 minutes, twice a week, for 6 weeks within
the participants own living facility, no extra traveling is required and will
be supervised by a physiotherapist. The movements exerted by the Balanseat are
very small and of no risk for the participants. Balanseat is CE certified and
will be used as intended. Earlier experience gained from Balanseat, based on a
case-series test in elderly in an assisted living facility in Israel, showed
that the exercise with the Balanseat was of no burden at all. The Go-Safe
activity tracker is worn as a small necklace and is also of no burden or
discomfort. The physical activity tests (TUG, 10MWT, SPPB, FRT) are part of
regular measurements by physiotherapists, are validated for elderly people and
of no risk. All physical test take approximately 30 minutes and take place at
baseline, after 3 and 6 weeks within the participants own living facility, so
no extra traveling is required.
According to the national guidelines on prevention of fall incidents (richtlijn
preventie van valincidenten bij ouderen, Nederlandse Vereniging voor Klinische
Geriatrie 2017) all mobile institutionalized elderly are at risk of mobility
problems. This makes this population suitable for doing this research. All
participants benefit from participating because they gain insight of their
physical status and are given advise and information about gaining/remaining a
healthy lifestyle and are motived to be active.