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A community-based, bionic leg rehabilitation program for patients with chronic stroke: clinical trial protocolWright, Amy; Stone, Keeron; Lambrick, Danielle; Fryer, Simon; Stoner, Lee; Tasker, Edward; Jobson, Simon; Smith, Grace; Batten, John; Batey, Jo; et al. (Elsevier, 2017-10-30)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-centre, 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 which 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 either: i) physiotherapy plus community-based bionic leg training program, ii) physiotherapy only, or iii) 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 assessment, identical to baseline, will occur after 10-weeks, 3 and 12 months post intervention. 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.
Effect of combined home-based, overground robotic-assisted gait training and usual physiotherapy on clinical functional outcomes in people with chronic stroke: a randomized controlled trialWright, Amy; Stone, Keeron; Martinelli, Louis; Fryer, Simon; Smith, Grace; Lambrick, Danielle; Stoner, Lee; Jobson, Simon; Faulkner, James; University of Winchester; University of Gloucestershire; Hobbs Rehabilitation; University of Gloucestershire; University of Chester; University of Southampton; University of North Carolina; University of Winchester; University of Winchester (SAGE, 2020-12-27)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±81m vs. 158±93m, respectively; P0.001) but not for control (122±92m vs. 119±84m, respectively). Findings were similar for Functional Ambulation Categories, Dynamic Gait Index and Berg Balance Scale (all P0.01). 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<.05). The differences observed in all of the aforementioned outcome measures were maintained at 22-weeks, 12 weeks after completing the intervention (all P >.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.