Supplemental therapeutic conventional vs. robotic upper limb exercise in acute stroke rehabilitation a randomized: Assessor blinded study

Objectives: To compare and determine improvements on upper limb functional abilities recovery through intense ULE early after stroke using two interventions, the robotic device Armeo-Spring® (ARMEO) vs. therapist supervised Table Top (TT) exercises. Methods: Setting - Tertiary rehabilitation hospital, acute stroke inpatient rehabilitation program (IRF). Design - Blinded, randomized, pilot study. Participants - Acute stroke patients with unilateral hemiparesis ≥ 18 years of age with a minimum Fugl-Meyer Assessment (FMA) score of 8/66 or Modified Ashworth Scale (MAS) score of <;3. Intervention - Participants were randomized to TT or AREMO ULE groups in addition to usual required 3 hours of inpatient therapy. Main Outcome Measures - Number of completed treatment sessions; withdrawals; serious/adverse events; FuglMeyer Assessment (FMA), Functional Independence Measure (FIM); FIM efficiency; Modified Borg Rating of Perceived Exertion Scale (RPE) for the therapist. Results: Thirty-five participants enrolled in the study thus far (ARMEO=18 TT=17). Four participants withdrew from the study: one due to fatigue; one “did not want to participate any longer” (n=2) and medical complications. ARMEO participants on average had more training days (6.6) than TT (5.8), but did not report statistical significance (p =.65). FIM efficiency was not significant, however, was higher for the TT group (1.6 ± .70) than the ARMEO group (1.4 ± .54), a mean difference of -.16 (95% CI, -.65 to 0.32), p = .49. There was not a statistically significant median decrease in Borg when trained in either the ARMEO 0r TT group, p = .25, p = .56, respectively. Five ARMEO participants reported adverse events (AEs) (n=3, stomach issues; n=3, pain; n=2, fatigue; n=1, ARMEO malfunction. Eight TT participants reported AEs (n=2, stomach issues; n=2, fatigue; n=2, pain; n=1, fall; n=2, hypertension; n=2, scheduling issue). No serious adverse events (SAEs) were reported. Conclusions: This ongoing, blinded, randomized study depicts an acute post-stroke population that received standard IRF and an additional upper extremity exercise program. Based on these preliminary data, it is feasible to provide a supplemental functional exercise program in an IRF without SAEs or loss of compliance with regulations. Further data collection will determine the longterm functional impact of acute, post-stroke additional high intensity exercise and the use of robotic devices beyond to gain efficiency in rehabilitation care.