Research Article

Effects of Pharyngeal Electrical Stimulation on Swallow Timings, Clearance and Safety in Post-Stroke Dysphagia: Analysis from the Swallowing Treatment Using Electrical Pharyngeal Stimulation (STEPS) Trial

Table 1

Baseline characteristics for participants in STEPS: excluded vs. included (); included (, PES vs. sham). Data are number (%), median [interquartile range], or mean (standard deviation). Comparison by Chi-Square (Exact) Test/Fisher’s Exact Test (binary/ordinal variables) or Welch’s -Test (continuous variables).

AllExcludedIncludedPESSham

Patients1264581814338
Age, 12673.4 (11.4)73.3 (11.8)73.4 (11.2)0.988172.8 (10.0)74.1 (12.5)
Sex, female (%)12649 (38.9)15 (33.3)34 (42.0)0.458121 (48.8)13 (34.2)
Ethnicity, white (%)126108 (85.7)43 (95.6)65 (80.2)0.0318139 (90.7)36 (94.7)
Modified Rankin Scale (/6)1264.1 (1.0)4.0 (1.1)4.1 (1.0)0.47813.9 (1.0)4.4 (0.9)
Barthel Index (/100)12628.9 (29.8)31.4 (30.8)27.4 (29.4)0.488133.8 (32.7)20.1 (23.4)
Stroke3 (6.7)12 (14.8)0.25814337
Previous (%)12615 (11.9)9 (20.9)3 (7.9)
Type, ischaemic (%)11096 (87.3)32 (86.5)64 (87.7)1.007333 (86.8)31 (88.6)
Side of CT lesion (%)1230.25804337
 Left55 (44.7)20 (46.5)35 (43.8)19 (44.2)16 (43.2)
 Right50 (40.7)14 (32.6)36 (45.0)18 (41.9)18 (48.6)
 No lesion18 (14.6)9 (20.9)9 (11.3)6 (14.0)3 (8.1)
Syndrome (%)1260.3181
 TACS35 (27.8)13 (28.9)22 (27.2)11 (25.6)11 (28.9)
 PACS49 (38.9)14 (31.1)35 (43.2)21 (48.8)14 (36.8)
 Lacunar41 (32.5)17 (37.8)24 (29.6)11 (25.6)13 (34.2)
 POCS1 (0.8)1 (2.2)0 (0)0 (0)0 (0)
Severity, NIHSS (/42)12610.1 (6.5)9.5 (7.3)10.4 (6.0)0.488110.1 (6.1)10.8 (5.9)
Dysphasia, NIHSS (%)12644 (34.9)13 (28.9)31 (38.3)0.338117 (39.5)14 (36.8)
Onset to randomisation (days) mean (SD)12616.2 (9.9)15.2 (8.3)16.8 (10.7)0.338115.4 (10.3)18.4 (11.1)
Median [IQR]14 [11]15.0 [12]14.0 [16]15.5 [15]13.0 [13]
DSRS (/12)1267.4 (3.7)7.8 (3.7)7.1 (3.7)0.35817.4 (4.0)6.8 (3.2)
TOR-BSST, failed (%)126122 (96.8)45 (100)77 (95.1)0.308141 (95.3)36 (94.7)
Feeding route (%)1260.14814338
 Oral, normal diet7 (5.6)5 (11.1)2 (2.5)2 (4.7)0 (0)
 Oral, soft diet36 (28.6)9 (20.0)27 (33.3)13 (30.2)14 (36.8)
 Nasogastric70 (55.6)27 (60.0)43 (53.1)25 (58.1)18 (47.4)
 PEG2 (1.6)0 (0)2 (2.5)2 (4.7)0 (0)
 Other11 (8.7)4 (8.9)7 (8.6)1 (2.3)6 (15.8)
Weight (kg)12673.0 (16.1)74.1 (16.5)72.4 (15.9)0.588171.5 (14.8)73.4 (17.2)
Body mass index (kg/m2)12225.6 (4.9)25.7 (4.9)25.5 (4.9)0.887725.8 (4.3)25.3 (5.5)
Mid-arm circumference (cm)12528.5 (3.6)28.2 (3.4)28.6 (3.7)0.618028.3 (3.4)28.9 (4.0)
Albumin (g/L)1203.6 (0.6)3.6 (0.6)3.7 (0.5)0.44773.7 (0.6)3.6 (0.5)
Chest infection (%)1265 (4.0)3 (6.7)2 (2.5)0.35811 (2.3)1 (2.6)

CT: computed tomography; DSRS: dysphagia severity rating scale; ICH: intracerebral haemorrhage; NIHSS: National Institutes of Health Stroke Scale; PEG: percutaneous endoscopic gastrostomy; TACS: total anterior circulation syndrome; PACS: partial anterior circulating syndrome; POCS: posterior communicating syndrome; TOR-BSST: Toronto Bedside Swallowing Screening Test. PES group associated with lower mRS () and higher Barthel Index ().