RANDOMISED CONTROLLED FEASIBILITY TRIAL OF SWALLOW STRENGTH AND SKILL TRAINING WITH SURFACE ELECTROMYOGRAPHIC BIOFEEDBACK IN ACUTE STROKE PATIENTS WITH DYSPHAGIA (ID 417)
Abstract
Background And Aims
Swallow strength and skill training with biofeedback may improve dysphagia in chronic stroke. We investigated whether it was feasible in acute stroke.
Methods
We conducted a prospective randomised controlled parallel group feasibility trial at one UK centre. Participants were randomised 1:1 to biofeedback (up to ten swallow strength and skill training sessions with biofeedback and usual care) or control (usual care). Primary outcomes were feasibility and acceptability. Secondary measures included safety, clinical outcomes, swallow function and physiology.
Results
Twenty-seven participants (13 Biofeedback, 15 Control) were recruited 22 (10) days post stroke, age 73 (SD 11), female 70%, functional oral intake scale (FOIS) 3 [IQR 1]); NIHSS was higher in the biofeedback group (13.1 vs 8.7). 85% of participants completed >80% of sessions; failed sessions related to participant availability and fatigue. Sessions lasted average 36 (7) minutes. 92% found the intervention comfortable with satisfactory administration time, frequency and time post stroke. 42% found it appropriately challenging. There were no treatment related serious adverse events. At 2-weeks biofeedback was associated with non-significantly higher FOIS, 5 [3] vs 4 [2], odds ratio 0.29 (95% CIs 0.1-1.2, p =0.07, ordinal logistic regression) and lower Dysphagia Severity Rating Scale 3.2 (3) vs 4.3 (2), mean difference -0.16 (95% CIs -3.29-1.51, p=0.45, multiple linear regression) both adjusted for baseline FOIS and NIHSS.
Conclusions
Swallow strength and skill training with surface electromyography biofeedback is safe, feasible and acceptable in acute stroke. Larger trials investigating treatment fidelity, dose and efficacy are warranted.
Trial Registration Number
NCT03499574.
