A Self-Empowered Upper Limb Repetitive Engagement Program to Improve Upper Limb Recovery Early Post-Stroke: Phase II Pilot Randomized Controlled Trial

Abstract

Background. Time outside therapy provides an opportunity to increase upper limb (UL) use during post-stroke hospitalization. Objective. To determine if a self-directed UL program outside therapy (Self-Empowered UL Repetitive Engagement, SURE) was feasible and to explore the potential effect of the SURE program on UL use and recovery. Methods. Twenty-three patients from an inpatient rehabilitation center who were ≤21 days post-stroke and had a Fugl Meyer UL (FMUL) score ≤50 and a positive motor evoked potential (MEP+) response were randomized (stratified by impairment) to either experimental group (SURE: individualized, UL self-exercise and use outside therapy for 6 hours/week for 4 weeks) or control group (education booklet). Feasibility was evaluated by program adherence, dropout rate, adverse events, and satisfaction. Potential effect was measured by paretic UL use via accelerometry weekly during the intervention, FMUL and Action Research Arm Test (ARAT) at baseline (Week 0), post-intervention (Week 4), and follow-up (Week 8 and Week 16). Results. Adherence to SURE was high: 87% program completion (mean 313±75 repetitions/day). There were no dropouts, no adverse events related to SURE, and patient satisfaction averaged 7.8/10. Experimental participants achieved an additional hour of UL use daily (range: .3–1.2 hours/day) compared to control. Significant improvements in FMUL and ARAT were observed in both groups from Week 0 to Week 4 and to Week 8 ( P ≤ .002), which were maintained to Week 16. There were no differences between groups ( P ≥ .119). Conclusions. SURE was a feasible self-directed program that increased UL use in MEP+ individuals with moderate-severe impairment early post-stroke. Further studies with larger sample sizes and potentially higher dose are required to determine efficacy.