Cue2Walk, cost-effectiveness of automated freezing detection and provision of external cues in comparison to usual care in people with Parkinson*s disease

Freezing of gait (FoG) is one of the most common and disabling motor symptoms
of Parkinson*s disease (PD). It is characterized by the sudden, transient, and
involuntary inability to produce ongoing forward locomotion. It is a highly
debilitating symptom of PD, a risk factor for cognitive decline, leads to
impaired mobility, daily functioning, gait instability, to fall-related
injuries and associated medical costs and severely affects quality of life
(QoL). Approximately 50-75% of the total worldwide population of people with PD
incur FoG. In the Netherlands this amounts to about 37000 people.

Currently, rehabilitation therapy is the treatment of choice for people with
FoG as it responds only moderately to medication or other forms of treatment,
such as deep brain stimulation. A number of studies have shown that FoG is
significantly associated with poorer QoL in PD, which supports the need for
innovative rehabilitation strategies. External cueing is a proven strategy to
overcome FoG episodes and an essential part in the management of FoG, in
combination with other forms of compensation strategies. Typically, a standard
metronome is used that patients need to activate themselves after FoG occurs.
However, this is often too late to adequately address sudden FoG, the metronome
requires continuous handling by the user and thus has limited effectiveness. In
addition, lack of initiative and apathy are common symptoms in PD, compounding
the problem of self-administration of cueing methods.

A literature review of literature up to August 2020 found that training aimed
at reducing FoG episodes or ameliorating the underlying correlates of FoG was
moderately effective compared to usual care, while generic exercises were not.
Relevantly, no retention effects were seen after cessation of training. This
review thereby supports the implementation of targeted training and medical
devices as a treatment for FoG with the need for long-term engagement. The
Cue2Walk approach explicitly addresses the above mentioned problems and needs.

The Cue2Walk, a Medical Device Class I CE-certified leg-worn device, addresses
the debilitating effects of FoG episodes at home with *smart cueing* by
combining automatic detection of a freezing episode with manual or automatic
rhythmic cues (auditory or vibro-tactile) to improve QoL. It may significantly
reduce the need for frequent visits to the physical therapist. The organization
of care changes from supervised training trajectory to a coaching trajectory in
which the therapist monitors the rehabilitation process at longer intervals.
The patient independently uses the device to enhance mobility and therefore the
Cue2Walk promotes self-management in the own home environment, ultimately
leading to a more satisfying life with enhanced QoL.

Results from a pilot study among 16 users of the Cue2Walk are promising, with
reduced severity of FoG, increased self-reported general health status and no
experienced detrimental effects. Therefore we hypothesize that the use of the
Cue2Walk medical device in rehabilitation therapy for PD patients with FoG will
result in an improved QoL as compared to usual care, as well as reduced health
care costs and a reduction in Time in Freezing of Gait. Expected secondary
outcomes are amongst others: reduced fall events, improved Falls Efficacy,
improved Activities of Daily Living, better mobility, better mood and reduced
caregiver burden as compared to usual care.

The aim of this study is to determine whether the at-home use of Cue2Walk
medical device in people with PD who experience FoG, is (cost-)effective as
compared to usual care.

We will conduct an observer-blinded, multicenter randomized clinical trial with
2 parallel groups. The intervention group (Group 1) will receive a 24-week
intervention and the control group (Group 2) will be placed on a waiting list
for 24 weeks. After these 24 weeks, an 8-week naturalistic follow-up will be
implemented for participants in Group 1, while participants in Group 2 will
receive the same intervention as Group 1, but for 8 weeks.

The intervention is 24 weeks in duration. In the first week, the participants
in Group 1 will be instructed on general therapy goals as well as on use and
handling of the device, and how to adequately respond to the cueing signals
that the device generates. The Cue2Walk is worn during the waking hours and
only provides a cueing signal when needed, i.e., when freezing of gait has been
detected. The participant immediately starts using the device. Therefore, the
participants use the wearable device in their own living environment during the
entire 24-week period. Participants can contact Cue2Walk using mail or chat via
a secure portal on the project website for additional instruction or
clarification. Technical support can be given remotely via the secure Cue2Walk
Int. support portal. Usage of this e-health component will be encouraged and
monitored. All other medical care will continue as usual.

Participants allocated to Group 2 will be placed on a waiting list for 24
weeks, during which they will receive usual care.

After these 24 weeks, an 8-week naturalistic follow-up will be implemented for
participants in Group 1, while participants in Group 2 will receive the same
intervention as Group 1, but for 8 weeks.

Participants may benefit from this study as the Cue2Walk device is aimed at
reducing the severity of FoG, which is associated with increased QoL. Pilot
data among 16 users of the device showed that none of the users had experienced
any detrimental effects. Participants will continue receiving usual medical
care, so no risks are expected.
Screening will take place at Amsterdam UMC, location VUmc, at Radboudumc or at
the home of the participant. The Cue2Walk is worn during the waking hours and
only provides a cueing signal when needed, i.e., when freezing of gait has been
detected. The 24-week intervention will be performed in the own living
environment.
Participants will be asked to fill out various questionnaires at home at
various time points throughout the study.