Stroke Clinical Trial
Official title:
Tactile Sensitivity of the Oral Tissues and Chewing Efficiency Are Impaired in Stroke Patients
Orofacial impairment following stroke frequently involves a reduced chewing performance and
dysphagia. This study investigated the sensitivity of oral tissues following stroke and its
potential impact on chewing efficiency.
The following two Null-hypotheses (H0) were tested:
i. Post-stroke patients do not show a reduced intra-oral sensitivity compared to a healthy
controls.
ii. Intra-oral sensitivity is not correlated to chewing efficiency.
Material and Methods:
Ethical approval was granted (Psy11-259, Psy 11-032) and written informed consent was
obtained from all participants and/or their legal guardian. Patients were screened and
recruited from the Division of Neurorehabilitation, Department of Clinical Neurosciences,
University Hospital and University of Geneva, Geneva, Switzerland by a senior consultant
neurologist (BL). Patients were included if they were hospitalized for stroke
rehabilitation, were able to undergo psychophysical testing and presented with a facial
impairment according to the House-Brackmann criteria ≥2 15. They were excluded if they
presented with acute pain in the oro-facial sphere (nominal question) or an additional
neuro-muscular disease.
For the experiments, an in-depth oral examination was performed and the number of functional
premolar units (OU) was noted. A premolar tooth with occluding antagonist counts as one OU
whereas a molar is considered two OU (including third molars). Participants were asked with
a simple dichotomic question if they perceived a dry mouth.
Food-hoarding Food-hoarding was assessed with an ordinal Likert scale. Participants were
asked if they currently "lost" foodstuff in the oral vestibule: Never (score 0), rarely
(score1), occasionally (score2), frequently (score 3), very frequently (score 4) or always
(score 5).
Maximum voluntary bite force Maximum voluntary Bite Force (MBF) was assessed by means of an
Occlusal Force-Meter GM 10® (Nagano Keiki, Higashimagome, Ohta-ku, Tokyo, Japan), which has
an 8.6 mm thick bite element. The gauge was placed in-between the first molars and the
participants were asked to bite three times as hard as possible for about three seconds. The
MBF was tested independently on the right and left side. For the analysis, the peak MBF of
each side was noted.
Maximum voluntary lip force For the lip force measurements an oral screen (Dentaurum " Ulmer
Modell " maxi, DENTAURUM GmbH&Co.KG, Ispringen, Germany) was connected to a Dynamometer
(ZP50-N, IMADA, Toyohashi, Japan). It was placed in the anterior oral vestibule and a
horizontal pulling force was applied whilst the participant tried to withstand the force as
long as possible. Per size, three peak recordings were averaged for analysis.
Tactile detection thresholds The tactile detection threshold (TDT) of mechanoreceptors was
evaluated using psychophysical testing methods. A touch sensation was elicited using von
Frey filaments (OptiHair, MARSTOCK nerv test, Schriesheim, Germany) 16. This test kit
consists of 11 monofilaments of varying stiffness, which are calibrated to apply defined
forces of 0.25 - 512 mN (±10%). The filaments were pushed vertically for about 1 second to
the different test sites on each side (ipsi- and contra-lesional in stroke-patients and
right- and left side in controls). The tests started with a supra-threshold stimulus, which
was consecutively lowered until the patient did not feel the filament anymore. Following the
filament with the lowest perceived pressure, the applied force was re-increased until the
patient recognized the touch again. This procedure was repeated twice in the same session to
find the threshold with the stair-case-method. The final threshold was calculated from the
mean of the three infra- and three supra-thresholds. If the patient felt even the lowest
stimulus available (0.25mN), the infra-threshold was set to 0.125mN.
Two-point discrimination To determine the patients' tactile spatial resolution, the static
two-point discrimination threshold (2PD) was investigated 17. The smallest distance between
two simultaneously presented punctiform stimuli was evaluated using a medical calliper
(Schieblehre Zürcher Modell, 125mm, Hammacher Instrumente, Germany). The separation between
the two tips ranged from 0 to 15 mm; the cut-off was set to 15 mm. A staircase method was
used with descending distances. The participant was asked to indicate whether he/ she sensed
one or two points and the corresponding distances were noted. The mean between those two
distances was considered as individual minimum 2PD.
The 2PD tests sites were the extraoral surface of the lip (approximately half way between
philtrum and oral commissure) and the dorsum of the tongue opposing the second premolar. For
TDT, the mucosa of the cheek opposing the second premolar and on the linea alba was used as
additional test site. Whereas these test sites were evaluated on both sides, the 2PD test
was additionally applied to the tip of the tongue without side discrimination. For one
particular analysis all TDT readings per participant were averaged (TDT.global).
Chewing efficiency Chewing efficiency was assessed with a previously developed and validated
colour-mixing ability test, or bolus-kneading test, using chewing gum 18. The specimens used
for this study were developed and produced for the 8020 Promotion Foundation (Japan)
specifically for assessing masticatory performance in a research setting (Lotte™,Tokyo) and
to be similar to the originally described method 19. The gum was composed of two
individually packed beads (pink and azure colour) with similar hardness Shore Scale OO, Ø
2.4 mm, 1.11 N, pink beads: mean depth of indentation 0.2±0.01mm, mean Durometer 93.7; azure
beads mean depth of indentation 0.1±0.02mm, mean Durometer 95.1). The two beads were
manually stuck together and had a dimension of 18.8x14.2x3.9 mm; they were placed on the
participant's tongue. The task was to chew the specimen for twenty cycles whilst being
monitored by the operator (ED). The gum bolus was then retrieved from the oral cavity,
placed into a plastic bag, pressed to a 1 mm thick wafer and both sides were scanned at
300dpi (Epson Perfection V750 Pro, Seiko Epson Corp., Japan).
The compound images of both sides were then subject to a colourimetric evaluation using the
custom-built software ViewGum© (dHAL Software, Greece, www.dhal.com).
The software transposes the images to the HSI colour space and then calculates the hue value
for each pixel in the pictures of the semi-automatically segmented gum wafers. If the
colours are not mixed, two well-separated peaks on the hue axis are present which will
gradually converge with increasing colour mixture. "Hue" is an angle in the HSI colour
space, thus the circular variance of hue is defined as 1 minus the length of the average
vector. ViewGum© displays the standard deviation between those colour peaks by taking the
square root: SD = sqrt (Variance of Hue) 20. For consistency, the term Variance of Hue (VOH)
will be used 18; it is considered as the measure of chewing performance in the context of
this test - with a lower VOH indicating a higher the colour mixture and therefore a better
chewing efficiency.
Statistical analysis Normality of all numerical variables was rejected with empirical
cumulative distribution function and QQ-plots. Therefore, results are reported as median
values ± standard deviation. The two groups (stroke, controls) were compared with exact
Wilcoxon-, Mann-Whitney-tests for numerical data and Fisher's exact tests for categorical
data.
Numerical and linear regression models were computed to analyse the impact of the
investigated parameters on VOH. The relationship between a variable and a numerical
end-point was measured with a Spearman correlation coefficient and a correlation test. In
the case of a binary variable the end-point was transformed into a categorical variable that
separates the values below and above the median. Odds Ratios OR and 95% Confidence Intervals
(95%CI) were calculated to analyse the resulting 2x2 contingency table. All statistical
tests were performed with R 3.2.2 (R Project for Statistical Computing, Vienna, Austria) by
a senior bio-statistician.
;
Observational Model: Case Control, Time Perspective: Cross-Sectional
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