AUTHOR=Sivertsen Marianne , Arntzen Ellen Christin , Alstadhaug Karl Bjørnar , Normann Britt 

TITLE=Effect of innovative vs. usual care physical therapy in subacute rehabilitation after stroke. A multicenter randomized controlled trial

JOURNAL=Frontiers in Rehabilitation Sciences

VOLUME=3

YEAR=2022

URL=https://www.frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2022.987601

DOI=10.3389/fresc.2022.987601

ISSN=2673-6861

ABSTRACT=<sec><title>Background</title><p>Research on stroke rehabilitation often addresses common difficulties such as gait, balance or physical activity separately, a fragmentation contrasting the complexity in clinical practice. Interventions aiming for recovery are needed. The purpose of this study was to investigate effects of a comprehensive low-cost physical therapy intervention, I-CoreDIST, vs. usual care on postural control, balance, physical activity, gait and health related quality of life during the first 12 weeks post-stroke.</p></sec><sec><title>Methods</title><p>This prospective, assessor-masked randomized controlled trial included 60 participants from two stroke units in Norway. Participants, who were randomized to I-CoreDIST (<italic>n</italic> = 29) or usual care physical therapy (<italic>n</italic> = 31), received 5 sessions/week when in-patients or 3 sessions/week as out-patients. Primary outcomes were the Trunk Impairment Scale-modified Norwegian version (TISmodNV) and activity monitoring (ActiGraphsWgt3X-BT). Secondary outcomes were the Postural Assessment Scale for Stroke, MiniBesTEST, 10-meter walk test, 2-minute walk test, force-platform measurements and EQ5D-3L. Stroke specific quality of life scale was administered at 12 weeks. Linear regression and non-parametric tests were used for statistical analysis.</p></sec><sec><title>Results</title><p>Five participants were excluded and seven lost to follow-up, leaving 48 participants in the intention-to-treat analysis. There were no significant between-group effects for primary outcomes: TIS-modNV (<italic>p</italic> = 0,857); daily average minutes of sedative (<italic>p</italic> = 0.662), light (<italic>p</italic> = 0.544) or moderate activity (<italic>p</italic> = 0.239) and steps (<italic>p</italic> = 0.288), or secondary outcomes at 12 weeks except for significant improvements on EQ5D-3L in the usual care group. Within-group changes were significant for all outcomes in both groups except for activity levels that were low, EQ5D-3L favoring the usual care group, and force-platform data favoring the intervention group.</p></sec><sec><title>Conclusions</title><p>Physical therapy treatment with I-CoreDIST improved postural control, balance, physical activity and gait during the first 12 weeks after a stroke but is not superior to usual care.</p></sec>