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| Randomized controlled trial of robot-assisted gait training with dorsiflexion assistance on chronic stroke patients wearing ankle-foot-orthosis |
| Yeung L-F, Ockenfeld C, Pang M-K, Wai H-W, Soo O-Y, Li S-W, Tong K-Y |
| Journal of NeuroEngineering & Rehabilitation 2018 Jun 19;15(51):Epub |
| clinical trial |
| 5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: Robot-assisted ankle-foot-orthosis (AFO) can provide immediate powered ankle assistance in post-stroke 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. Repeated-measures 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 touch-down at initial contact (foot tilting +1.91 degrees). Sham group reported reduction in affected leg range of motion (ankle dorsiflexion -2.36 degrees and knee flexion -8.48 degrees) 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.
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