Telerehabilitation using a 2-D planar arm rehabilitation robot for hemiparetic stroke: a feasibility study of clinic-to-home exergaming therapy

BACKGROUND: We evaluated the feasibility, safety, and efficacy of a 2D-planar robot for minimally supervised home-based upper-limb therapy for post-stroke hemiparesis. 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 robotics-assisted therapy (RAT) at home for 30 consecutive days, after 2 therapist-supervised clinic on-boarding sessions. Web-based compliance measures were: accessed sessions of > 20 min/day, training minutes/day and active training hours/30 days. Clinical outcomes 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 Home-RAT 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 h ± 14. 7/30 days, 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 -S144/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. TRIAL REGISTRATION: NCT05212181 (https: //clinicaltrials. gov).