TECHNOLOGY-SUPPORTED SITTING BALANCE THERAPY VERSUS USUAL CARE IN THE CHRONIC STAGE AFTER STROKE: A PILOT RANDOMIZED CONTROLLED TRIAL (ID 769)

Abstract

Background And Aims

Insights in evidence on sitting balance and trunk rehabilitation have not resulted in specific device development. We developed a novel rehabilitation prototype, specifically aimed at providing sitting balance therapy. In this study, we investigated if 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 participants into two groups. The experimental group received additional therapy supported by rehabilitation technology consisting of 12 sessions of 50 minutes of therapy in four weeks. Feasibility and safety were descriptively analysed. Between-group analysis evaluated the differences in changes in motor and functional outcomes.

Results

Twenty-Nine of 30 completed the trial (experimental group, n=14; control group, n=15). There were no between-group differences at baseline. Therapy was evaluated feasible. 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 training after stroke is feasible and safe and suggests beneficial effects for trunk function, maximum gait speed and functional balance.

Trial Registration Number

ClinicalTrials.gov identifier: NCT04467554

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