Overground robotic-assisted gait training (O-RAGT) has been shown to improve clinical functional outcomes in people living with stroke. The purpose of this study was to identify whether a home-based O-RAGT program, in combination with usual care physiotherapy, would demonstrate improvements in vascular health in individuals with chronic stroke, and, whether any changes in vascular outcomes would be sustained 3 months after completing the program. Thirty-four participants with chronic stroke (between 3 months and 5 years post-stroke) were randomized to either a 10-week O-RAGT program in combination with usual care physiotherapy, or to a usual care physiotherapy only control group. Participants' (n = 31) pulse wave analysis (PWA), and regional [carotid-femoral pulse wave analysis (cfPWV)] and local (carotid) measures of arterial stiffness were assessed at baseline, post-intervention, and 3-month post-intervention. Analysis of covariance demonstrated a significant reduction (improvement) in cfPWV between BL and PI for O-RAGT (8.81 ± 2.51 vs. 7.92 ± 2.17 m/s, respectively), whilst the control group remained unchanged (9.87 ± 2.46 vs. 9.84 ± 1.76 m/s, respectively; p < 0.05; ηp2 = 0.14). The improvement in cfPWV was maintained 3 months after completing the O-RAGT program. There were no significant Condition by Time interactions for all PWA and carotid arterial stiffness measures (p > 0.05). A significant increase in physical activity, as determined by the time spent stepping, was observed for O-RAGT between baseline and post-intervention assessments (3.2 ± 3.0–5.2 ± 3.3%, respectively) but not for CON (p < 0.05). The improvement in cfPWV, in combination with an increase in physical activity whilst wearing the O-RAGT and concomitant reduction in sedentary behavior, are important positive findings when considering the application of this technology for “at home” rehabilitation therapy for stroke survivors. Further research is needed to determine whether implementing “at home” O-RAGT programs should be a part of the stroke treatment pathway.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT03104127.
Objectives: To assess the effect of a home-based over-ground robotic-assisted gait training program using the AlterG Bionic Leg orthosis on clinical functional outcomes in people with chronic stroke. Design: Randomized controlled trial. Setting: Home. Participants: Thirty-four ambulatory chronic stroke patients who recieve usual physiotherapy. Intervention: Usual physiotherapy plus either (1)10-week over-ground robotic-assisted gait training program (n = 16), using the device for ⩾30 minutes per day, or (2) control group (n = 18), 30 minutes of physical activity per day. Measurements: The primary outcome was the Six-Minute Walk Test. Secondary outcomes included: Timed-Up-and-Go, Functional Ambulation Categories, Dynamic Gait Index and Berg Balance Scale. Physical activity and sedentary time were assessed using accelerometry. All measurements were completed at baseline, 10 and 22 weeks after baseline. Results: Significant increases in walking distance were observed for the Six-Minute Walk Test between baseline and 10 weeks for over-ground robotic-assisted gait training (135 ± 81 m vs 158 ± 93 m, respectively; P ⩽ 0.001) but not for control (122 ± 92 m vs 119 ± 84 m, respectively). Findings were similar for Functional Ambulation Categories, Dynamic Gait Index and Berg Balance Scale (all P ⩽ 0.01). For over-ground robotic-assisted gait training, there were increases in time spent stepping, number of steps taken, number of sit-to-stand transitions, and reductions in time spent sitting/supine between baseline and 10 weeks (all P < 0.05). The differences observed in all of the aforementioned outcome measures were maintained at 22 weeks, 12 weeks after completing the intervention (all P > 0.05). Conclusion: Over-ground robotic-assisted gait training combined with physiotherapy in chronic stroke patients led to significant improvements in clinical functional outcomes and physical activity compared to the control group. Improvements were maintained at 22 weeks.
Stroke is a major global health problem whereby many survivors have unmet needs concerning mobility during recovery. As such, the use of robotic-assisted devices (i.e., a bionic leg) within a community setting may be an important adjunct to normal physiotherapy in chronic stroke survivors. This study will be a dual-center, randomized, parallel group clinical trial to investigate the impact of a community-based training program using a bionic leg on biomechanical, cardiovascular, and functional outcomes in stroke survivors. Following a baseline assessment that will assess gait, postural sway, vascular health (blood pressure, arterial stiffness), and functional outcomes (6-minute walk), participants will be randomized to a 10-week program group, incorporating (1) a physiotherapy plus community-based bionic leg training program; (2) physiotherapy only; or (3) usual care control. The training program will involve participants engaging in a minimum of 1 hour per day of bionic leg activities at home. Follow-up assessments, identical to baseline, will occur after 10 weeks, and 3 and 12 months postintervention. Given the practical implications of the study, the clinical significance of using the bionic leg will be assessed for each outcome variable. The potential improvements in gait, balance, vascular health, and functional status may have a meaningful impact on patients' quality of life. The integration of robotic devices within home-based rehabilitation programs may prove to be a cost-effective, practical, and beneficial resource for stroke survivors.
Robotic-assisted gait training is becoming an important component of the rehabilitation strategy when working with patients diagnosed with a stroke. To date, research has largely focused on the effect of using robotic-assisted devices on lower limb function through the assessment of gait and balance parameters in sub-acute and chronic stroke patients, in a clinical setting. However, there may be significant benefit of implementing robotic-assisted gait training devices in the acute hospital setting soon after stroke diagnosis, but also with chronic stroke patients as a home-based rehabilitation tool. This article concludes that further research is needed when considering the influence of robotic-assisted technology on the early mobilisation (i.e., ability to stand and walk with and/or without the support from a therapist) of stroke patients in the hospital setting, their implementation in a home-based environment, and the need to incorporate more robust, quantifiable and scientific techniques to evaluate stroke patient progress through a variety of biomechanical assessment parameters.