Clinical and kinematic evaluation of the H-Man arm robot for post-stroke upper limb rehabilitation: Preliminary findings of a randomised controlled trial

Abstract

The H-Man robot, a table-top, portable, 2D planar, end-effector with virtual reality feedback was designed to deliver self-paced, repetitive reaching arm movements. Preliminary results of a randomized clinical trial of 26/44 strokes with hemiparetic arm weakness are presented. Inclusion criteria included first-stroke, > 4 months duration with Fugl Meyer Assessment Scale (FMA) 20–50/66) without contraindications to robot-aided therapy. Following informed consent, subjects were randomized into 2 groups: H-Man-conventional (HCT) group received 18 sessions over 6 weeks of 60 minutes of H-man training then 30 minutes of conventional therapy (CT), while control group (CG) received a similar intensity of 90 minutes of CT. Blinded outcome assessments at weeks 0 (baseline), 3, 6 (end-training), 12 and 24 (follow-up). The primary outcome measure was FMA change at week 6. Parametric analysis was used and level of significance was P < 0.05. Altogether, data from 26 out of 44 subjects were analyzed. (13 HCT, 13 CG). Mean age was 54.0 years (SD 10.9), 14/26 were male, 15/26 had hemorrhagic strokes, mean stroke duration 227.2 days (SD 207.2), and mean baseline FMA 38.6 (SD 11.1). The HCT group achieved significantly better FMA gains compared to CG (4.15 HCT vs. 1.69 CG, P = 0.03) at week 6 (post-training), and at week 24 (5.77 HCT vs 2.61 CG, P = 0.03). There were no adverse side effects or drop outs. Robotic kinematic measures of line and circle temporal tracing correlated with FMA scores at Week 0. Combinatory arm rehabilitation with H-Man robot was superior to CT and well tolerated.