So, you incompetently didn't create a protocol on this for survivors to find and use? I'd have your mentors and senior researchers fired! Doesn't anyone in stroke realize that the whole point of stroke research is to get survivors recovered? This doesn't do that!
Overground robotic exoskeleton vs conventional therapy in inpatient stroke rehabilitation: results from a pragmatic, multicentre implementation programme
Journal of NeuroEngineering and Rehabilitation volume 22, Article number: 3 (2025)
Abstract
Background
Despite the reported efficacy of overground robotic exoskeleton (ORE) for rehabilitation of mobility post-stroke, its effectiveness in real-world practice is still debated. We analysed prospectively collected data from Improving Mobility Via Exoskeleton (IMOVE), a multicentre clinical implementation programme of ORE enrolling participants with various neurological conditions and were given options to choose between 12 sessions of ORE or conventional therapy (control).
Methods
This is analysis of participants under IMOVE who fulfilled the following criteria (i) primary diagnosis was stroke (ischemic, hemorrhagic; first or recurrent), (ii) onset of stroke was within 9 months and (iii) the intervention was during inpatient stay. They should also fulfill the general IMOVE inclusion and exclusion criteria which were resembling general clinical and manufacturing criteria of ORE. Outcome measures included Functional Ambulatory Category (FAC), Rivermead Mobility Index (RMI), Functional Independence Measure (FIM) and Clinical Outcome Variable Scale (COVS), measured immediately before and after the 12 sessions of therapy, and mean distance walked per session.
Results
Of 149 participants (105 OREs and 44 controls), both groups improved significantly in motor outcomes with no significant between-group differences. Participants with baseline FAC 1 had significantly greater improvement in motor sub-score of FIM (FIM-motor) compared to controls (mean difference 8.4, 95% CI 0.65–16.07, ηp2 = 0.136, p = 0.034). The mean distance walked per session for ORE group was almost three times that of control for those with baseline FAC 0 (121.5 [SD 31.1]m vs 35.0 [SD 41.0]m, 95% CI 62.2–110.9, d = 2.54 p < 0.001) and FAC 1 (145.8 [SD 31.6]m vs 52.2 [SD 42.5]m, 95% CI 61.8–125.2, d = 2.71, p < 0.001). The difference was not observed for FAC 2 to 3 (162.9 [SD 29.2]m vs 134.2 [SD 87.5]m, 95% CI −22.2 to 79.7, d = 0.41, p = 0.252).
Conclusion
In a pragmatic setting, use of ORE for gait training enabled patients with lower ambulatory capacity to walk longer distances during therapy sessions. Patients who required continuous assistance during ambulation (FAC 1) had significantly better gains in FIM-motor compared to conventional therapy, suggesting possible benefit of ORE for this group.
Trial Registration
The trial was registered with clinicaltrials.gov (NCT05659121) on April 14, 2022.
Background
Studies from across Europe, America and Asia have found that at least 60% of patients have difficulty in ambulation after a stroke [1,2,3]. Retraining the ability to walk is a priority in post-stroke rehabilitation. Intensity, task-specificity and amount of walking practice is crucial in the rehabilitation of ambulatory function [4] and different types of robotic gait training devices have been developed to augment the intensity and dosage of gait-related training, including exoskeletons and end-effectors [5]. Overground robotic exoskeletons (ORE) have gained popularity in recent years, with advantages of allowing greater interaction with the environment, full weight-bearing, more appropriate sensorimotor integration, more degrees of freedom of movement, greater variability in gait parameters and mobility tasks that can be trained, compared to platform-tethered, body weight-supported robotic devices[6].
Despite multiple studies examining the efficacy of robotic gait training, the role of ORE in real world post-stroke rehabilitation is unclear. A Cochrane review including all electromechanical gait training devices concluded that robotic gait training in combination with physiotherapy increased the odds of independent walking after stroke, with greater benefit in the early phase of stroke [7]. While some studies suggest the benefits of various OREs to improve walking capacity and speed [6], others have reported mixed results[8,9,10,11,12]. Meta-analyses comparing ORE use with conventional therapy post-stroke, which included a heterogenous collection of single- and multi-joint devices, found greater improvement in walking speed, balance, longer-term mobility, with equivocal benefits reported for endurance [13, 14]. However, as data were mostly derived from randomised clinical trials (RCTs), patient selection criteria are typically more stringent, the intensity of therapy, including duration and step count per session and total number of sessions, are typically higher than usual clinical practice, and parameter settings of the device and control interventions are also more strictly controlled. RCTs therefore might provide an inadequate estimate of the actual effectiveness of robotic device in real-world clinical settings [15]. Patients who are typically excluded in RCTs, such as those with recurrent stroke or co-morbidities, may not have the same response rates and magnitude as those reported in RCTs [16].
The aim of this study was to evaluate the effectiveness of ORE in real-world clinical settings by analysing prospectively collected data from a cohort with pragmatic selection criteria and treatment protocol. The “Improving Mobility Via Exoskeleton” (IMOVE) programme, a philanthropy-funded multicentre ORE clinical programme in Singapore which sought to implement the use of EksoGT® ORE at various rehabilitation settings (inpatient and outpatient tertiary, community hospital settings and community day rehabilitation centres) from the acute to chronic phases of rehabilitation. IMOVE patient recruitment, treatment group allocation, treatment dosage, progression and duration of intervention reflected real-world practices, so as to inform clinical practices related to ORE application.
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