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Effect of innovative versus usual care physical therapy in subacute rehabilitation after stroke. A multicenter randomized controlled trial
Sivertsen M, Arntzen EC, Alstadhaug KB, Normann B
Frontiers in Rehabilitation Sciences 2022 Sep 19;3(987601):Epub
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: 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, versus usual care on postural control, balance, physical activity, gait and health related quality of life during the first 12 weeks post-stroke. METHODS: This prospective, assessor-masked randomized controlled trial included 60 participants from two stroke units in Norway. Participants, who were randomized to I-CoreDIST (n = 29) or usual care physical therapy (n = 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. RESULTS: 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 (p = 0.857); daily average minutes of sedative (p = 0.662), light (p = 0.544) or moderate activity (p = 0.239) and steps (p = 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. CONCLUSIONS: 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.

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