Effects of Device-Facilitated Lingual Strengthening Therapy on Dysphagia Related Outcomes in Patients Post-Stroke: A Randomized Controlled Trial.

The study was underpowered for its planned comparisons. The power analysis targeted 12 participants per group, but only 19 participants had 8-week data and only 8 per group had 12-week data. Analyses were per protocol, so participants who dropped out or had missing outcome data were not included in each timepoint comparison. The sample was small and recruited mainly from an inpatient setting, and many participants were still within early stroke recovery. Average days from infarct to enrollment were 52.4 for treatment and 40 for control, so natural recovery may have contributed to improvement in both groups. The treatment group received device tongue exercise in addition to usual care, so the contribution of the tongue exercise alone cannot be separated from usual care. Barium bolus volumes and consistencies varied across participants and timepoints, so liquid and solid trials were pooled for analysis. Inclusion was broad: a single Penetration-Aspiration Scale score of 3 or higher, or a residue score of 2, was enough for entry, rather than a more specific swallowing impairment profile. Blinding of participants and treating clinicians is not described. Only the randomizing biostatistician and the barium-swallow video raters are described as blinded.

The supplied text lists research support from N.I.H., Extramural in the publication types. It does not include a conflicts-of-interest declaration.

Do not read the better oral intake at 8 weeks as proof that device tongue exercise works. The primary tongue-pressure outcome was null, the study was underpowered, and the exercise was given alongside usual care.