The main question this research tries to answer is: How does this balance belt affect balance and gait during walking? Secondary research question: How do participants experience this belt in terms of usability?
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
evenwichtsproblemen door ouderdom (evenwichtsorgaan, spierzwakte, slechter zicht)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in quantitative gait and balance measures between the feedback
and no-feedback circuits.
Secondary outcome
Quantitative usability assessment with the UMUX-LITE, but especially the
qualitative feedback in response to this questionnaire (leading to
recommendations for improvement of the orthesis)
Background summary
A prevalent problem in elderly (and all XoSoft primary user groups) is an
impaired sense of balance. The XoSoft system itself will not be able to keep
the primary user in balance, but with external feedback, the user herself may
be able to correct the situation. A balance orthesis has been developed in the
form of a belt to provide intuitive, helpful feedback on mediolateral
(left-right) upper body tilt during walking, which may help improve posture and
motion and prevent falls.
Study objective
The main question this research tries to answer is: How does this balance belt
affect balance and gait during walking? Secondary research question: How do
participants experience this belt in terms of usability?
Study design
A cross-over study, where no-feedback and feedback phases will be alternated
(ABAB) in order to address learning effects and participant fatigue.
Intervention
Each participant executes a gait and balance task circuit repeatedly with and
without external feedback from the balance belt.
Study burden and risks
BURDEN: Participants visit the lab only once for a duration of 1h30, during
which they will be exposed to a series of gait and balance tasks. As
participants will be locals, there is only a minimal burden of travel time.
During the experiment, participants wear low-heeled shoes and a t-shirt or
something similar to provide a thin layer of fabric between the belt and the
skin.
At the start there will be one questionnaire for general patient information, a
semi-structured interview to assess fall history based on Freiberger & Vreede
(2011), and Short FES-I questionnaire to assess fear of falling. At the end
there is an UMUX-LITE questionnaire combined with an open dialog to assess the
usability of the balance belt.
During the experiment, the participant will wear various sensors for
measurement and the balance belt which contains one sensor (XSens MTW Awinda
IMU) to determine mediolateral upper-body tilt and a string of vibration motors
(Elitac Science Suit) to provide feedback.
RISK: Because feedback will be provided on balance during gait there is a
certain risk for loss of balance if this feedback is incorrect or if the
participant is startled by the feedback (risk reduced by a balance belt
training session as part of the protocol). For safety, a researcher will be
walking next to the participant. Safety grips attached to the participant's
waist allow the researcher to respond quickly if necessary. Participants can
verbally express their discomfort and wish to pause or discontinue at any time.
BENEFIT: The vibration feedback might lead to adjustment of upper body sway
during walking, which in turn could result in an improved dynamic balance. The
focus of this experiment, however, is to see whether there is an effect at all
and to evaluate the usability of the orthesis. Evaluating the effect and
usability of this balance orthesis is a necessary step in the development
process of this orthesis, in making it available for home use in the future,
and the burden and risks for the participants are small.
RELATEDNESS: Balance problems are a prevalent problem in elderly. The proposed
balance feedback might be helpful for elderly who are otherwise fit and able to
walk independently without the need for mobility aids.
Van Galenstraat 19
Enschede 7511JL
NL
Van Galenstraat 19
Enschede 7511JL
NL
Listed location countries
Age
Inclusion criteria
- Age: 60-90 years old
- Community-dwelling * living independently at home
- Able to walk independently without walking aids on even and uneven surfaces
- Able to stand independently for 10 minutes
- Self-perception of minor balance problems [14], such as a light fear of
falling
(actual balance problems further assessed through the Fear of Falling and Fall
history questionnaires)
- Able to sit and have their joints (arms, legs, ankles, hip) bent in natural
angles (for calibration of the IMU sensors)
- Able to wear the balance belt around the waist or the additional sensors on
arms, legs and torso.
- Able to read and understand patient information forms, understand questions
and able to execute commands
- Able and willing to participate in the study
- Signed Informed Consent
Exclusion criteria
- Neurological or orthopedic impairment that would limit their ability to stand
or walk, such as Parkinson's disease or polyneuropathy
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 | NL67633.044.18 |