Journal of Rehabilitation Medicine 51-10 | Page 32

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J.-S.Park et al.
FOIS consists of a 7-point scale, with level 1 indicating com-
plete impairment of oral intake and level 7 implying complete
oral intake regardless of food consistency or type This scale
exhibits a reliability rating of Cronbach’s α = 0.86–0.91 (17). A
0-to-10 numerical rating self-report scale was used after every
training session to assess motivation, enjoyment/interest, physical
effort needed, and muscle fatigue of the exercise. On this scale,
0 indicated no motivation, not enjoyable, and pain/fatigue (13).
All assessments were completed before and after the inter-
vention by an experienced occupational therapist who was
blinded to the participants’ group allocation. The assessments
were performed immediately before the start of the intervention
(pre-training) and after the 4-week treatment (post-training).
Statistical analysis
Statistical analyses were performed using SPSS version 15.0
(IBM Corp., Armonk, NY, USA). Descriptive statistics are pre-
sented as means with standard deviations. The Shapiro–Wilk test
was used to check the normality of the outcome variables. To
evaluate the training effects, the paired t-test was used to com-
pare measures before and after the intervention in each group.
The independent t-test was used to compare post-intervention
values and changes in outcome measures between the 2 groups.
The significance level was set at p < 0.05.
RESULTS
General characteristics of the subjects
Table II. Participants’ characteristics
Characteristics Experimental
group
Control group
Age, year, mean (SD)
Sex, man/woman, n
Type of stroke, haemorrhage/infarction, n
Paretic side, right/left, n
Time since onset of stroke months, mean (SD) 60.95 (11.19)
13/7
12/8
11/9
3.60 (1.19)
59.45 (9.34)
10/10
14/6
13/7
3.85 (1.18)
SD: standard deviation.
also showed significant improvement in the oral and
pharyngeal phases of VDS, PAS and FOIS (p < 0.05,
all). After the intervention, there was no significant
difference in the oral and pharyngeal phases of VDS
(p = 0.443 and 0.335), PAS (p = 0.069) and FOIS
(p = 0.403) between the 2 groups (Table III). A com-
parison of the amount of change in the groups showed
no significant differences in the oral and pharyngeal
phases of VDS (p = 0.624 and 0.689), PAS (p = 0.403)
and FOIS (p = 0.191) (Table IV).
Drop-out rate and side-effects
There was no drop-out in the experimental group, in
terms of compliance with the gbCTAR exercise. In
contrast, in the control group, 4 patients dropped out
because of temporary pain, fatigue and discomfort in
the neck. However, the discomfort as temporary, and
no patient reported additional side-effects (Fig. 3).
A total of 46 subjects were enrolled in the study. Nine
participants dropped out prior to the follow-up for the
following reasons: discharge
(n = 3), hospital transfer (n = 2),
Enrollment
and neck pain, fatigue, and
discomfort (n = 4). Therefore,
the data for the final 37 subjects
were analysed. Fig. 3 shows
the Consolidated Standards of
Reporting Trials (CONSORT)
diagram for participant recruit-
ment. A summary of the clinical
and demographic features of
the subjects (n = 37) is shown in
Allocated to intervention (n=23)
Table II. The homogeneity test
• Game-based chin tuck against resistance
for each measurement item sho-
exercise
• Traditional dysphagia treatment
wed no significant differences in
baseline characteristics between
the groups (p > 0.05).
Assessed for eligibility (n=60)
Excluded (n=14)
Not meeting inclusion criteria (n=12)
Declined to participate (n=2)
Randomized (n=46)
Allocation
Allocated to intervention (n=23)
• Head lift exercise
• Traditional dysphagia treatment
Follow -Up
Lost to follow-up (n=4) Lost to follow-up (n=5)
Swallowing function • Transferred to other hospital before
completing this study (n=2) • Pain, fatigue and discomfort in the neck
The experimental group showed
statistically significant improve-
ment in the oral and pharyngeal
phases of VDS, PAS and FOIS
(p < 0.05, all). The control group • Discharge (n=2) • Discharge (n=1)
www.medicaljournals.se/jrm
(n=4)
Analysis
Analysed (n=19)
Fig. 3. Study flow diagram.
Analysed (n=18)