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J.-S.Park et al.
in this exercise, the jaw is moved downwards against
resistance using an elastic body (see Fig. 1), while sit-
ting, in order to strengthen the same submental muscles
as those targeted in the HLE; hence, the expected effect
is similar to that of HLE. Sze et al. (11) demonstrated
that CTAR exercise is more efficient than HLE because
it the activates submental muscles similar to or higher
than the HLE. As a result, patients were able to perform
the exercise more easily than HLE, and the drop-out
rate, which was moderate, also decreased. Park et al.
(9) demonstrated that CTAR exercise is effective in
decreasing aspiration, residue in valleculae, pyriform
sinuses and increasing laryngeal elevation/epiglottic
closure. However, previous studies on CTAR exercise
have reported limitations of the exercise; for example,
the intensity of resistance cannot be controlled using
simple tools, such as elastic balls and elastic synthetic
resins. In resistance training, applying an appropriate
resistance intensity according to the patient’s condition
is very important. In addition, simple and repetitive
training methods have low motivation for rehabilitation
training because substantial physical effort is requi-
red for resistance training. Therefore, the resistance
strength can be adjusted, and a supplement to provide
motivation for resistance training is needed.
Studies using games software for rehabilitation
have been reported (12–14). The game is intuitive and
has the advantage of enhancing patient engagement
because it can be enjoyable and interesting (13). In
addition, it is possible to obtain immediate feedback,
and adjust the force (control of resistance) alone, and
the accuracy is improved by detecting performance
error. These advantages of game-based exercises can
be applied to the existing CTAR exercise. The aims
of this study were therefore to investigate the effect
of game-based CTAR (gbCTAR) exercise in patients
with dysphagia after stroke, and to compare the results
with those of HLE.
MATERIAL AND METHODS
Participants
Participants were recruited from the rehabilitation centre centre
(InJe University Hospital, Busan) in South Korea. Forty-six stroke
patients with dysphagia were eligible for the study, which was
conducted from October 2018 to March 2019. Inclusion criteria
were: diagnosed as having had a stroke within 6 months post-on-
set; pharyngeal dysphagia confirmed through a videofluoroscopic
swallowing study (VFSS); ability to follow study instructions;
ability to swallow voluntarily; only liquid aspiration or penetra-
tion observed on a VFSS; presence of a nasogastric tube; ability to
use at least one arm; absence of any cognitive deficits (a score of
> 22 points in the Mini-Mental Status Examination; MMSE); and
cortex damage only. Exclusion criteria were: secondary stroke;
presence of other neurological diseases; pain in the disc and
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cervical spine; cervical spine orthosis; presence of a gastrostomy
tube; and problems with the oesophageal phase of dysphagia (e.g.
achalasia or upper oesophageal sphincter opening dysfunction),
as confirmed by VFSS. The study protocol was approved by the
Institutional Review Board of Seoul Medical Center in South
Korea (SEOUL 2019-03-001), and all participants provided
written informed consent for study participation. The patient’s
permissions to publish this study were obtained including picture.
Sample size estimation
To perform a sample size calculation, the G-Power 3.1 software
(University of Dusseldorf, Dusseldorf, Germany) was used. The
power and alpha levels were set at 0.80 and 0.05, respectively.
In addition, the effect size was set at 0.85. According to a prior
analysis, each group required at least 18 subjects. Therefore,
this study assigned 23 participants to each group in preparation
for drop-out.
Instrumentation
LES 100 (LES 100, Cybermedic Inc., Iksan in South Korea)
consists of a tablet PC screen, a resilient resistance bar, and a
Bluetooth connector, and implements a game-based exercise in
which the chin is tucked down against a resilient resistance bar to
strengthen the suprahyoid muscles. The subject sits 30 cm away
from the 8-inch tablet PC on the table and tucks the chin down-
ward against the resistance bar to reach the target (set resistance
value) displayed on the screen. At this time, the external force
applied to the resistance bar is displayed on the screen through
the pressure system. The maximum force (1-RM) applied to the
resistance bar when the chin tuck is performed using a resistance
bar is measured to determine the resistance value of the motion
before exercise; the resistance value starts at 70% of 1-RM.
Intervention
Eligible participants were allocated to the experimental or
control group using blocked randomization after taking baseline
measures (block size = 4). Allocation was concealed using sealed
opaque envelopes.
The experimental group performed the gbCTAR exercise
using the LES 100 device. The participants in the experimental
group were instructed to sit on a chair and place both arms on
the desk. A 10-inch tablet PC was placed approximately 30 cm
away from the desk. Before the gbCTAR exercise, 1-RM was
measured to determine resistance training values. For the 1-RM
measurement, the resistance bar was placed directly beneath
the jaw, and the chin tuck was directed strongly against the
resistance. The gbCTAR exercise was performed at a threshold
value of 70% 1-RM. The exercise was divided into isometric
and isotonic exercises in combination with the game, based on
a previous study (8) (Fig. 1).
The control group performed HLE in the supine position,
based on the previous study (4). Conventional HLE was divided
into isometric and isotonic exercises (Fig. 2).
Table I shows the gbCTAR exercise and HLE protocol per-
formed by the 2 groups. Both groups received the same type of
exercise, and the time involved in the exercise was also the same.
The intervention was conducted 5 times a week for 4 weeks by
3 experienced occupational therapists. In addition, both groups
received traditional dysphagia treatment (TDT) from skilled oc-
cupational therapists (30 min a day). TDT included oral facial
massage, thermal-tactile stimulation and various compensatory
training (e.g. head tilting, rotation, chin tuck).