The main objective of this study is to assess the effect of visual cues (provided by smart glasses) in the form of visual lines on the floor on walking performance and occurrence of FOG in comparison to walking without visual cues and walking with…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Walking tasks will be video-taped and rated for the presence of FOG by two
experienced raters.
Secondary outcome
In addition, participants will wear some accelerometers on their body (XSens),
using which we can calculate gait parameters such as step length.
Background summary
Freezing of gait (FOG) is a common and debilitating phenomenon in Parkinson*s
disease (PD). FOG is defined as a brief, episodic absence or marked reduction
of forward progression of the feet despite the intention to walk. External
cueing, i.e. providing external sensory stimuli during gait and gait-related
activities, is a good option to non-invasively provide alleviation of FOG.
Unfortunately, the positive impact of external cueing therapy in a laboratory
setting does not necessarily generalize to uncued living activities. Since
patients experience difficulties generalizing the skills taught in the clinic
or in a home training program to uncued situations, permanent cueing devices
may be essential to follow-up and maintain the progresses achieved. Recent
advances in mobile technology have made it possible to widely provide cueing
therapy through smart glasses. We have developed a cueing application (app) for
smart glasses platforms that can guide gait in PD-patients. In a pilot study in
which 10 PD-patients with FOG were included, our initial observations show that
the rhythmic visual and auditory cues applied via smart glasses decreased the
number and duration of FOG episodes compared to walking tasks without smart
glasses, when tested in a laboratory setting. Patients were enthusiastic about
the rhythmic visual cues provided by smart glasses, but also asked for visual
cues in the form of imaginary lines on the floor. We have further developed our
cueing application, and are now able to display visual lines on the floor. In
the coming study in our movement laboratory at the University of Twente, we
would like to evaluate the effect of visual cues in the form of visual lines on
the floor on the occurrence and duration of FOG in patients with Parkinson*s
disease.
Study objective
The main objective of this study is to assess the effect of visual cues
(provided by smart glasses) in the form of visual lines on the floor on walking
performance and occurrence of FOG in comparison to walking without visual cues
and walking with conservative rhythmic cues (such as metronome). To this
purpose, participants will come once to our movement laboratory at the
University of Twente. Patients will be asked to perform a series of walking
tasks, with and without cues (lines on the floor provided by smartglasses and
conservative rhythmic cues). Walking tasks will be video-taped and rated for
the presence of FOG. In addition, participants will wear some accelerometers on
their body (XSens), using which we can calculate gait parameters such as step
length.
Study design
This is an explorative study aiming to test the functional efficacy of visual
cueing by smart glasses on FOG in patients with Parkinson's disease.
Participants will come once to our movement laboratory at the University
Twente. Patients will be asked to perform a series of walking tasks, with and
without cues provided by smart glasses and with conservative rhythmic cues
Intervention
Visual cues will be provided via smart glasses.
Study burden and risks
Patients with FOG are subject to falls. We do not expect that walking with
smart glasses aggravates the risk of falls. During the walking tasks, one of
the researchers will walk with the patient, so the patient cannot fall. This
study is therefore not dangerous and poses no risk to the patients.
Achter de Carmel 28
Nijmegen 6511CT
NL
Achter de Carmel 28
Nijmegen 6511CT
NL
Listed location countries
Age
Inclusion criteria
• Men/women of age > 18 years with idiopathic Parkinson*s disease, as diagnosed by the UK Brain Bank Criteria (Hughes et al. , 1992).
• Written informed consent.
• Presence of FOG (defined as a score of 1 on question 1 "Have you experienced FOG in the past month" from the NFOGQ).
• Disabling/regular FOG (defined as a score of 3 "Very often, more than one time a day" on question 2 "How often do you experience FOG" from the NFOGQ).
• Patients need to use conservative cues in daily life.
Exclusion criteria
• Presence of stroke in history or a psychiatric disease.
• Severe visual impairments.
• Severe co-morbidity (such as orthopedic problems) limiting ambulation.
• Severe cognitive impairments (MMSE<24).
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 | NL54149.044.15 |
Other | we hebben onze studie aangemeld bij trialsregister.nl; een nummer hebben we nog niet ontvangen. |