Domiciliary Gaze Stability and Oculomotor Exercises Improves Balance After Stroke. Better Balance, a Randomized Controlled Trial

Abstract Title: Domiciliary gaze stability and oculomotor exercises improves balance after stroke. BetterBalance, a randomized controlled trial Authors: Anabela Correia1,2, Carla Pimenta1,2, Marta Alves3, Daniel Virella3 1. Physiotherapy Department, Hospital Curry Cabral, Centro Hospitalar Universitário Lisboa Central, Portugal. 2. Department of Rehabilitation Science and Technology, Escola Superior de Tecnologia da Saúde de Lisboa, Instituto Politécnico de Lisboa, 3. Epidemiology and Statistics Office of the Research Unit, Centro Hospitalar Universitário Lisboa Central, Portugal. Background: Visual stabilization and the vestibulo-ocular reflex as mechanisms of gaze stability are needed to coordinate the movements of the head, trunk and pelvis during walking. Balance impairment after stroke is strongly associated with more severely impaired motor function, a decrease in recovery potential and an increase of the number of falls. Purpose: To verify the efficacy of a domiciliary training program for balance impairment after stroke in senior patients. Methods: Patients older than 60 years, discharged after stroke to the physiotherapy department, were recruited to a randomized controlled trial for improving orthostatic balance (ClinicalTrials.gov: NCT02280980). Eligible patients had stroke 3-15 months earlier, positive Romberg test and autonomous walk for ³3m. Participants were allocated (block randomization by age, balance and functionality) into the current rehabilitation program (observational group - OG) or into a supplemental intervention focused on a domiciliary program of oculomotor and gaze stability exercises (intervention group - IG) for three weeks. Primary outcome was the incidence of falls; the variation of the estimated risk for falls by Berg Balance Scale (BBS) and Timed Up and Go Test (TUG) were surrogate outcomes: minimum difference of 4 seconds in TUG and 4 points in BBS. Data were analyzed by per protocol. Relative Risk (RR) for the outcome was estimated with 95% confidence interval (95%CI). Multivariable logistic regression was applied to model for the decrease of the risk for falls. Results: From the 217 referred patients, 71 were recruited and completed the protocol 61 patients (OG 32; IG 29), aged 60-87 years old (median OG 73; IG 74), similarly distributed by gender, type of stroke and reported falls before recruitment (OG 21/32; IG 15/29). No falls were registered in the IG and 4 patients fell in the OG. The surrogate outcome occurred in 11/32 OG patients and in 26/29 IG patients (RR 2.61; 95%CI 1.59 - 4.28; p<0.001); all the IG females reached the surrogate outcome. The increase of BBS was larger (p<0.001) in the IG (median difference 7 vs. 2); a weak evidence of difference on TUG was observed (median difference OG=-0.72 sec. and IG=-1.28 sec.; p=0.059). The model for decrease of the estimated risk for falls revealed that the intervention lead to a 21.4 fold increase on the odds (aOR 21.43; 95%CI 4.75 – 96.66; p