Correia A1,2, Pimenta C1,2, Alves M3, Virella D3
1Centro Hospitalar Universitário Lisboa Central, Physiotherapy Department, Hospital Curry Cabral, Lisboa, Portugal, 2Escola Superior de Tecnologia da Saúde de Lisboa, Instituto Politécnico de Lisboa, Department of Rehabilitation Science and Technology, Lisboa, Portugal, 3Centro Hospitalar Universitário Lisboa Central, Epidemiology and Statistics Office of the Research Unit, Lisboa, 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 > 3m. 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 0.001) and that females had 4.75 fold higher odds for decrease than males (aOR 4.75; 95%CI 1.11 - 20.25; p=0.035).
Conclusion(s): The trial did not reach power to assess the efficacy of the intervention as actually preventing falls, although evidence was obtained that complementary oculomotor and gaze stability exercises decrease the estimated risk for falls and that this decrease is larger in females.
Implications: Domiciliary oculomotor and gaze stability exercises are a promising approach as a complement in the physiotherapy intervention after stroke, whenever balance impairment is present. Given the high incidence of falls in these patients and their social and economic impact, this can be an efficient strategy to improve balance and reduce the risk for falls.
Keywords: fall risk, stroke, clinical trial
Funding acknowledgements: No external funding was granted to this study
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 > 3m. 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 0.001) and that females had 4.75 fold higher odds for decrease than males (aOR 4.75; 95%CI 1.11 - 20.25; p=0.035).
Conclusion(s): The trial did not reach power to assess the efficacy of the intervention as actually preventing falls, although evidence was obtained that complementary oculomotor and gaze stability exercises decrease the estimated risk for falls and that this decrease is larger in females.
Implications: Domiciliary oculomotor and gaze stability exercises are a promising approach as a complement in the physiotherapy intervention after stroke, whenever balance impairment is present. Given the high incidence of falls in these patients and their social and economic impact, this can be an efficient strategy to improve balance and reduce the risk for falls.
Keywords: fall risk, stroke, clinical trial
Funding acknowledgements: No external funding was granted to this study
Topic: Neurology: stroke
Ethics approval required: Yes
Institution: Centro Hospitalar Lisboa Central
Ethics committee: Comissão de ética para a saúde CHLC
Ethics number: Proc 140/2012
All authors, affiliations and abstracts have been published as submitted.
