Technology-supported sitting balance therapy versus usual care in the chronic stage after stroke: A pilot randomized controlled trial

Abstract

Insights in evidence on sitting balance and trunk rehabilitation have not resulted in specific device development. Hence, intensive one-by-one therapist-patient guidance is still required. We developed a novel rehabilitation prototype, specifically aimed at providing sitting balance therapy. In this study, we investigated if technology-supported sitting balance training was feasible and safe in chronic stroke patients and we evaluated whether clinical outcomes improved after a four-week programme when compared with usual care. Methods. In this parallel-group, assessor-blinded, randomized controlled pilot trial, we divided first event chronic stroke participants randomly into two groups. The experimental group received usual care plus additional therapy supported by rehabilitation technology consisting of 12 sessions of 50 minutes of therapy in four weeks. The control group received usual care only. We assessed all participants twice pre-intervention and once post-intervention. Feasibility and safety were descriptively analysed. Between-group analysis evaluated the differences in changes in motor and functional outcomes. Results. In total, 30 participants were recruited and 29 completed the trial (experimental group, n=14; control group, n=15). There were no between-group differences at baseline. Therapy was evaluated feasible by participants and therapist. There were no serious adverse events during sitting balance therapy. Changes in clinical outcomes from pre- to post-intervention demonstrated an increase in the experimental compared to the control group for trunk function; mean (standard deviation [SD]): 7.07 (1.69) versus 0.33 (2.35) points on trunk impairment scale (p<.000), maximum walking speed on 10-meter walk test (0.16 (0.16) m/s in the experimental group versus 0.06 (0.06) m/s in the control group; p=.003), and functional balance measured using Berg balance scale (median [interquartile range] 4.5 (5) points in the experimental group versus 0 (4) points in the control group (p=.014). Conclusions. Technology-supported sitting balance training in persons with chronic stroke is feasible and safe. A four-week, 12-hour programme on top of usual care suggests beneficial effects for trunk function, maximum gait speed and functional balance.Trial Registration: ClinicalTrials.gov identifier: NCT04467554, https://clinicaltrials.gov/ct2/show/NCT04467554, date of Registration: 13 July 2020.