Novel diagnostics in dysfunctional breathing using a wearable breathing trainer

Rationale: RIP bands are capable of accurately measuring breathing patterns in
patients and is therefore capable of measuring dysfunctional breathing patterns
in patients.
Objective: To study (the treatment of) dysfunctional breathing patterns using a
wearable breathing trainer.
Study design: Prospective cross-over study
Study population: 25 children aged 8-17 with paediatrician diagnosed
dysfunctional breathing
Intervention (if applicable): All children are treated by their physical
therapist while the wearable breathing trainer measures their breathing pattern
in the first visit. In the other study visit children are given feedback on
their breathing through vibrations given by the wearable breathing trainer
based upon their breathing pattern. Due to the cross over design of the study,
half of the children participate in the second visit first.
Main study parameters/endpoints: The primary goal of this study is to determine
the effects of breathing exercises given by the pediatric physiotherapist
objectively using RIP
These signal alterations allow for the following parameters to be measured:
• RIP amplitude
• RIP frequency
• RIP peak variation

Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: There are no risks associated with this study.
Participation entails two sessions at the physical therapist, all measurements
are conducted within regular care visits to the physical therapist and
therefore take no extra time to complete.

Primary study objective:
To impartially identify the focus of breathing (thoracic or abdominal) using
respiratory inductance plethysmography for children aged 8 to 18 with
dysfunctional breathing

Secondary objectives:
• To investigate the effects of vibrotactile feedback on breathing during
breathing exercises at the physical therapist
• To compare the effects of vibrotactile feedback to verbal and tactile
instructions given by the physical therapist
• To determine the performance of RIP measurements during breathing exercises
• To determine the experience of included patients (children) to use technology
to support breathing exercises

The wearable breathing trainer is a vest equipped with RIP bands capable of
measuring the focus of breathing in patients in individual breaths.
Additionally, it is equipped with actuators which can be used to steer the
focus of breathing towards the abdomen.

This study will be performed during regularly planned visits to the physical
therapist and will have a cross-over design. Subjects will be selected from the
Asthma Exercise and Research Centre of the Eastern Netherlands (AIRCON) at the
paediatrics department of MST. All subjects will be referred as usual, to the
physical therapist for their dysfunctional breathing pattern. Upon diagnosis
they will be informed about this study and if they are interested, they will be
provided with the PIFs for the appropriate age groups.

At the first visit, a treatment plan is set up in consultation with the
physical therapist. At this first visit, subjects and their parents are also
asked to bring the informed consent forms when making the appointment if they
wish to participate. If they forget but do wish to participate, they are
allowed to bring the informed consent forms to the second visit. No
measurements will be conducted prior to obtaining informed consent.

During the second and third visit, subjects will wear the wearable breathing
trainer. Half of the subjects will first perform the exercises with the
physical therapist as usual, whilst the wearable breathing trainer only
measures the breathing pattern (group A). At the next visit, subjects will
perform the exercises with the physical therapist whilst not receiving feedback
from their therapist, but from the vibrating motors in the wearable breathing
trainer. The other half will perform the exercises with the wearable breathing
trainer the other way around (group B). Participants will be divided into group
A or B by the investigator alternately. It is not possible to blind the
physiotherapist and patient after enrollment into the study.

A cross-over design makes it possible to compare the intervention with the
control condition within each participant. The alternating assignment of the
starting condition allows for the evaluation of starting physical therapy with
or without the intervention.

After the third visit an evaluation moment will be planned by the investigator
with the subject to evaluate the use of technology (RIP bands and actuators)
for applying haptic feedback. A semi-structured interview will take place with
topics based on the technology acceptance model (TAM) and Unified Theory of
Acceptance and Use of Technology (UTAUT).

We aim to include one subject every week after starting inclusion. At AIRCON we
examine over 700 patients each year, of which roughly 25% are diagnosed with
dysfunctional breathing. Earlier research has shown a large willingness to
participate in research that does not take any additional time and is performed
alongside regular care.

There are no risks associated with participation in this study. Furthermore,
participation entails measurements performed alongside regular care and
therefore do not provide an additional burden.