Randomized controlled trial of robot-assisted gait training with dorsiflexion assistance on chronic stroke patients wear
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RESEARCH
Open Access
Randomized controlled trial of robotassisted gait training with dorsiflexion assistance on chronic stroke patients wearing ankle-foot-orthosis Ling-Fung Yeung1, Corinna Ockenfeld2, Man-Kit Pang3, Hon-Wah Wai3, Oi-Yan Soo4, Sheung-Wai Li5 and Kai-Yu Tong1*
Abstract Background: Robot-assisted ankle-foot-orthosis (AFO) can provide immediate powered ankle assistance in poststroke gait training. Our research team has developed a novel lightweight portable robot-assisted AFO which is capable of detecting walking intentions using sensor feedback of wearer’s gait pattern. This study aims to investigate the therapeutic effects of robot-assisted gait training with ankle dorsiflexion assistance. Methods: This was a double-blinded randomized controlled trial. Nineteen chronic stroke patients with motor impairment at ankle participated in 20-session robot-assisted gait training for about five weeks, with 30-min over-ground walking and stair ambulation practices. Robot-assisted AFO either provided active powered ankle assistance during swing phase in Robotic Group (n = 9), or torque impedance at ankle joint as passive AFO in Sham Group (n = 10). Functional assessments were performed before and after the 20-session gait training with 3-month Follow-up. Primary outcome measure was gait independency assessed by Functional Ambulatory Category (FAC). Secondary outcome measures were clinical scores including Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), Berg Balance Scale (BBS), Timed 10-Meter Walk Test (10MWT), Six-minute Walk Test (SMWT), supplemented by gait analysis. All outcome measures were performed in unassisted gait after patients had taken off the robot-assisted AFO. Repeatedmeasures analysis of covariance was conducted to test the group differences referenced to clinical scores before training. Results: After 20-session robot-assisted gait training with ankle dorsiflexion assistance, the active ankle assistance in Robotic Group induced changes in gait pattern with improved gait independency (all patients FAC ≥ 5 post-training and 3-month follow-up), motor recovery, walking speed, and greater confidence in affected side loading response (vertical ground reaction force + 1.49 N/kg, peak braking force + 0.24 N/kg) with heel strike instead of flat foot touchdown at initial contact (foot tilting + 1.91°). Sham Group reported reduction in affected leg range of motion (ankle dorsiflexion − 2.36° and knee flexion − 8.48°) during swing. Conclusions: Robot-assisted gait training with ankle dorsiflexion assistance could improve gait independency and help stroke patients developing confidence in weight acceptance, but future development of robot-assisted AFO should consider more lightweight and custom-fit design. Trial registration: ClinicalTrials.gov NCT02471248. Registered 15 June 2015 retrospectively registered. Keywords: Stroke, Robotics, Exoskeletons, Ankle foot orthosis, Gait training
* Correspondence: [email protected] 1 Department of Biomedical Engineering, The Chinese University of Hong
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