Abstract
Aims: We evaluated the feasibility, safety and efficacy of a 2D-planar robot for minimally-supervised home-based upper-limb therapy for post-stroke hemiparesis.
Materials and Methods: The H-Man, end effector robot, combined with web-based software application for remote tele-monitoring were evaluated at homes of participants. Inclusion criteria were: strokes > 28 days, Fugl-Meyer Motor Assessment (FMA) >10-60/66, presence of a carer and absence of medical contraindications. Participants performed self-directed, minimally-supervised H-Man training for 30 consecutive days at their homes, after 2 therapist-supervised clinic on-boarding sessions. Web-based compliance measures were accessed sessions (>20mins/day), training minutes/day and active training hours/30days. Clinical outcomes obtained at weeks 0, 5 (post-training), 12 and 24 (follow-up) consisted of FMA, Action Research Arm Test (ARAT) and WHO-Stroke Specific Quality Of Life (SSQOL). To estimate immediate economic benefits of the home-based robotic therapy, we performed cost-effectiveness analysis (CEA), followed by budget impact analysis (BIA).
Results: Altogether, all 12 participants completed H-Man at home without adverse events; 9 (75.0%) were males, mean (SD) age, 59.4 years (9.5), median (IQR) stroke duration 38.6 weeks (25.4, 79.6) baseline FMA (0-66) 42.1 ±13.2, ARAT (0-57) 25.4 ±19.5, SSQOL (0-245) 185.3 ±32.8. At week 5 follow-up, mean (SD) accessed days were 26.3 days ±6.4, active training hours of 35.3 hours ±14.7/30days, or ~6 days/week and 77 training minutes ± 20.9/day were observed. Significant gains were observed from baseline across time; ΔFMA 2.4 at week 5 (FMA 44.5, CI 95% 39.7 – 49.3, p < 0.05) and ΔFMA 3.7 at week 24 (FMA 45.8, CI 95% 40.5 – 51, p < 0.05); ΔARAT 2.6 at week 5 (ARAT 28.0, CI 95% 19.3 – 36.7, p < 0.05), and ΔARAT 4.8 at week 24 (ARAT 30.2, CI 95% 21.2 – 39.1, p < 0.05). At week 5 follow-up, 91% of participants rated their overall experience as satisfied or very satisfied. Incremental CEA observed savings of -S$144/per cure over 24 weeks, BIA – potentially 12% impact reduction over five years.
Conclusions: This study demonstrates the feasibility, acceptability, safety, clinical efficacy and cost-effectiveness of a home-based, web-enabled telemonitored carer-supervised robotics-aided therapy.