CCFES in early-phase stroke rehabilitation
Patients in the CCFES group were treated with contralaterally
controlled functional electrical stimulation (two 20-min sessions
every day) combined with routine rehabilitation. Each session
consisted of 48 15-s sets, separated by 10 s of rest. Patients were
prompted by sound cues from the stimulator to actively extend
both wrists, then the paretic wrist was stimulated to complete
WD, assisted by the bioelectrical signal transmitted from the
non-paretic side, held still for 15 s when full WD was achieved,
then relaxed for 10 s.
Outcome assessment
A therapist was responsible for follow-up of the appearance of
WD and recorded the time intervals from the onset of stroke to
the appearance of WD (in days) and from the onset of treatment
to the appearance of WD (in days). All patients were followed up
for 1 month after inpatient treatment. The appearance of WD (a
minimal range of motion of 5°) indicated the first time of volitio-
nal WD, which was checked and reported by the therapists every
morning, afternoon and evening during the inpatient treatment
period. When the patients were discharged from the hospital,
the appearance of WD was reported by patients during everyday
training and activities (checked every morning, afternoon and
evening) and confirmed by the corresponding therapists via
phone, and videos recorded by family members.
The functional assessments were performed both at baseline
(before 2 weeks of training) and at endpoint (after 2 weeks
of training), including active ROM for WD measured with a
goniometer (range 0–45°), strength of the extensor carpi mea-
sured with Manual Muscle Testing (range 0–5), upper extremity
impairment measured with Fugl-Meyer assessment (FMA)
(range 0–66, presented as absolute scores: 0, cannot perform;
1, perform partially; and 2, perform fully, with higher score
indicating better upper extremity function) (9, 12, 13); hand
function measured with Jebsen Hand Function Test (JHFT)
(ranged 0–7 and presented as number of missions completed:
with more completed items indicating better function) (14),
and ADL measured with Modified Barthel Index (mBI) (range
0–100 and presented as absolute score: 0 and 100, with higher
scores indicating greater independence) (15). In addition, the
ICF Generic Set was used to evaluate patients’ general health
(range 0–10 and presented with absolute scores: 0 and 10, with
lower scores indicating better general health) (16).
Statistical analysis
Demographic data for the patients, including age, sex, stroke
classification and course of disease, in both groups were com-
pared using Student’s t-test and χ 2 test. Data on active ROM for
WD, strength of extensor carpi and JHFT were not normally
distributed; therefore non-parametric methods (Wilcoxon-rank
sum test) were applied to test for inter-group differences. Stu-
dent’s t-test was applied for testing the normally distributed data
including time intervals (from the onset of stroke to the appear-
ance of WD and from the onset of treatment to the appearance
of WD), FMA for upper extremity, mBI and ICF Generic Set.
All statistical analyses were performed using SPSS 20.0 (IBM
Corp, USA). p < 0.05 was considered statistically significant.
The study was powered based on data from Knutson et al. (9)
to detect differences in upper extremity FMA mean scores of
46.2 (standard deviation (SD) 2.1) in the CCFES group vs 41.1
(SD 2.2) in the NMES group at a significance level of 0.05 (10).
A minimum of 4 participants per group was required in order to
detect differences between groups with a power of 90%. In order
105
to power the current study, the sample size was increased to 20
in each group, with a total of 40 participants.
RESULTS
Demographic data
Based on the inclusion and exclusion criteria, 50
patients with early-stage stroke were eligible to join
the study, and were randomly assigned to the CCFES
group (n = 25) and the NMES group (n = 25). Nine
out of the total of 50 dropped out due to secondary
cerebral haemorrhage (1 in the CCFES group and 2
in the NMES group), compressive lumbar vertebrae
bone fracture after falling off a bed (1 in the CCFES
group), secondary cerebral infarction (1 in the CCFES
group and 2 in the NMES group), serious pulmonary
infection (1 in the CCFES group and 1 in the NMES
group). At the endpoint, 41 patients completed the
study (21 in the CCFES group and 20 in the NMES
group) (Fig. 2). No statistical difference was detected
between experimental groups in terms of the demo-
graphic data (Table I).
Inter-group comparisons at the endpoint
At the endpoint, 19 patients in the CCFES group and 12
in the NMES group had re-gained active WD. The mean
time interval from onset of stroke to appearance of WD
was 18.33 days (SD 7.01) for patients in the CCFES
group, which was approximately 23 days earlier than
for NMES group (Table II). In addition, a statistical dif-
ference was detected between groups in terms of mean
time interval from onset of treatment to appearance
of WD (10.48 (SD 5.46) days in the CCFES group vs
31.90 (SD 22.44) days in the NMES group, p < 0.001).
Statistical differences were observed in terms of the
FMA score of upper extremity (mean 29.6 (SD 26.34)
in the CCFES group vs 22.65 (SD 5.67) in the NMES
group, p = 0.001), strength of the extensor carpi (mean
2.29 (SD 0.78) in the CCFES group vs 1.20 (SD 1.06)
Table I. Demographic data of study sample
CCFES group NMES group
(n = 21)
(n = 20)
p-value
Age, mean (SD)
Sex, n (%)
Male
Female
Classification, n (%)
Ischaemic
Haemorrhagic
Time post-stroke (days), mean (SD)
63.38 (12.14) 61.35 (12.13) 0.595
0.294
15 (71.43)
17 (85.00)
–
6 (28.57)
3 (15.00)
–
0.948
18 (85.71)
17 (85.00)
–
3 (14.29)
3 (15.00)
–
7.86 (2.25)
8.50 (2.20)
0.242
CCFES: contralaterally controlled functional electrical stimulation; NMES:
neuromuscular electrical stimulation; SD: standard deviation. p < 0.05 indicates
statistically significant. Course of disease: time interval from onset of stroke
to onset of treatment.
J Rehabil Med 51, 2019