Dataset Information

Robotic-Assisted Gait Training (RAGT) in Stroke Rehabilitation: A Pilot Study.

ABSTRACT:

Objective

To compare the effects of 2 types of robotic-assisted gait training (RAGT) devices that have been used in stroke rehabilitation.

Design

Retrospective cohort.

Setting

Rehabilitation hospital.

Participants

24 community dwelling people with stroke (N=24).

Interventions

RAGT with either an exoskeleton (Lokomat) (mean age=53.8 years; 30% men; mean duration of stroke =17.8 months) or an end-effector (G-EO) (mean age=50.5 years; 77.8% men; mean duration of stroke =13.11) delivered 3 times per week (36 sessions total).

Main outcome measures

The following tests/scales were employed before and after RAGT: Functional Ambulation Categories (FACs), timed Up and Go (TUG), 10-Meter Walk Test (10MWT), 6-Minute Walk Test (6MWT), Trunk Impairment Scale, Dynamic Gait Index (DGI), Berg Balance Scale (BBS), and ability to climb stairs (time to climb 6 steps of 15 cm each; ability to climb stairs).

Results

There were 5 dropouts, all from the G-EO group. At the end, 10 participants in the Lokomat and 9 in the G-EO group completed the intervention. From pre- to post-RAGT, G-EO patients improved on all functional tests/scales, whereas Lokomat patients improved only on the TUG, DGI, and BBS. Most patients showed improvements above the relative smallest real difference in the TUG, 10MWT, and 6MWT.

Conclusions

Both end-effectors and exoskeletons may improve clinically relevant aspects of walking function. However, this study had a small sample, was retrospective, non-randomized, and had a significant number of drop-outs, therefore its findings should be interpreted carefully. Future studies are needed for investigating potential differences in clinical results, side effects, contraindications, and cost effectiveness between these 2 different types of RAGT.

SUBMITTER: Neves MVM

PROVIDER: S-EPMC10036220 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Robotic-Assisted Gait Training (RAGT) in Stroke Rehabilitation: A Pilot Study.

Neves Mariana Vita Milazzotto MVM Furlan Leonardo L Fregni Felipe F Battistella Linamara Rizzo LR Simis Marcel M

Archives of rehabilitation research and clinical translation 20230122 1

<h4>Objective</h4>To compare the effects of 2 types of robotic-assisted gait training (RAGT) devices that have been used in stroke rehabilitation.<h4>Design</h4>Retrospective cohort.<h4>Setting</h4>Rehabilitation hospital.<h4>Participants</h4>24 community dwelling people with stroke (N=24).<h4>Interventions</h4>RAGT with either an <i>exoskeleton</i> (<i>Lokomat</i>) (mean age=53.8 years; 30% men; mean duration of stroke =17.8 months) or an <i>end-effector</i> (<i>G-EO</i>) (mean age=50.5 years; ...[more]

PMID: 36968170

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Project description:BackgroundStroke is a leading cause of serious gait impairments and restoring walking ability is a major goal of physical therapy interventions. Soft robotic exosuits are portable, lightweight, and unobtrusive assistive devices designed to improve the mobility of post-stroke individuals through facilitation of more natural paretic limb function during walking training. However, it is unknown whether long-term gait training using soft robotic exosuits will clinically impact gait function and quality of movement post-stroke.ObjectiveThe objective of this pilot study was to examine the therapeutic effects of soft robotic exosuit-augmented gait training on clinical and biomechanical gait outcomes in chronic post-stroke individuals.MethodsFive post-stroke individuals received high intensity gait training augmented with a soft robotic exosuit, delivered in 18 sessions over 6-8 weeks. Performance based clinical outcomes and biomechanical gait quality parameters were measured at baseline, midpoint, and completion.ResultsClinically meaningful improvements were observed in walking speed ([Formula: see text] < 0.05) and endurance ([Formula: see text] < 0.01) together with other traditional gait related outcomes. The gait quality measures including hip ([Formula: see text] < 0.01) and knee ([Formula: see text] < 0.05) flexion/extension exhibited an increase in range of motion in a symmetric manner ([Formula: see text] < 0.05). We also observed an increase in bilateral ankle angular velocities ([Formula: see text] < 0.05), suggesting biomechanical improvements in walking function.ConclusionsThe results in this study offer preliminary evidence that a soft robotic exosuit can be a useful tool to augment high intensity gait training in a clinical setting. This study justifies more expanded research on soft exosuit technology with a larger post-stroke population for more reliable generalization. Trial registration This study is registered with ClinicalTrials.gov (ID: NCT04251091).

Project description:IntroductionPracticality of implementation and dosing of supplemental gait training in an acute stroke inpatient rehabilitation setting are not well studied but can have positive impact on outcomes.ObjectivesTo determine the feasibility of early, intense supplemental gait training in inpatient stroke rehabilitation, compare functional outcomes and the specific mode of delivery.Design and settingAssessor blinded, randomized controlled trial in a tertiary Inpatient Rehabilitation Facility.ParticipantsThirty acute post-stroke patients with unilateral hemiparesis (≥ 18 years of age with a lower limb MAS ≤ 3).InterventionLokomat® or conventional gait training (CGT) in addition to standard mandated therapy time.Main outcome measuresNumber of therapy sessions; adverse events; functional independence measure (FIM motor); functional ambulation category (FAC); passive range of motion (PROM); modified Ashworth scale (MAS); 5 times sit-to-stand (5x-STS); 10-m walk test (10MWT); 2-min walk test (2MWT) were assessed before (pre) and after training (post).ResultsThe desired supplemental therapy was implemented during normal care delivery hours and the patients generally tolerated the sessions well. Both groups improved markedly on several measures; the CGT group obtained nearly 45% more supplemental sessions (12.8) than the Lokomat® group (8.9). Both groups showed greater FIM improvement scores (discharge - admission) than those from a reference group receiving no supplemental therapy. An overarching statistical comparison between methods was skewed towards a differential benefit (but not significant) in the Lokomat® group with medium effect sizes. By observation, the robotic group completed a greater number of steps, on average. These results provide some evidence for Lokomat® being a more efficient tool for gait retraining by providing a more optimal therapy "dose".ConclusionsWith careful planning, supplemental therapy was possible with minimal intrusion to schedules and was well tolerated. Participants showed meaningful functional improvement with relatively little supplemental therapy over a relatively short time in study.

Project description:BackgroundStroke, the incidence of which increases with age, has a negative impact on motor and cognitive performance, quality of life, and the independence of the person and his or her family, leading to a number of direct and indirect costs. Motor recovery is essential, especially in elderly patients, to enable the patient to be independent in activities of daily living and to prevent falls. Several studies have shown how robotic training associated with physical therapy influenced functional and motor outcomes of walking after stroke by improving endurance and walking strategies. Considering data from previous studies and patients' needs in gait and balance control, we hypothesized that robot-assisted balance treatment associated with physical therapy may be more effective than usual therapy performed by a physical therapist in terms of improving static, dynamic balance and gait, on fatigue and cognitive performance.MethodsThis is an interventional, single-blinded, preliminary randomized control trial. Twenty-four patients of both sexes will be recruited, evaluated, and treated at the UOC Rehabilitation and Physical Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome from January to December 2022. Patients will be randomized into two groups: the experimental group will perform specific rehabilitation for balance disorder using the Hunova® robotic platform (Movendo Technology srl, Genoa, IT) for 3 times a week, for 4 weeks (12 total sessions), and for 45 min of treatment, in addition to conventional treatment, while the conventional group (GC) will perform only conventional treatment as per daily routine. All patients will undergo clinical and instrumental evaluation at the beginning and end of the 4 weeks of treatment.ConclusionsThe study aims to evaluate the improvement in balance, fatigue, quality of life, and motor and cognitive performance after combined conventional and robotic balance treatment with Hunova® (Movendo Technology srl, Genoa, IT) compared with conventional therapy alone. Robotic assessment to identify the most appropriate and individualized rehabilitation treatment may allow reducing disability and improving quality of life in the frail population. This would reduce direct and indirect social costs of care and treatment for the National Health Service and caregivers.Trial registrationClinicalTrials.gov NCT05280587. Registered on March 15, 2022.

Project description:In the last decade robotic devices have been applied in rehabilitation to overcome walking disability in neurologic diseases with promising results. Robot assisted gait training (RAGT) using the Lokomat seems not only to improve gait parameters but also the perception of well-being. Data on the psychosocial patient-robot impact are limited, in particular in the real-world of RAGT, in the rehabilitation setting. During rehabilitation training, the Lokomat can be considered an "assistive device for movement". This allowed the use of the Psychosocial Impact of Assistive Device Scale- PIADS to describe patient interaction with the Lokomat. The primary aim of this pilot study was to evaluate the psychosocial impact of the Lokomat in an in-patient rehabilitation setting using the PIADS; secondary aims were to assess whether the psychosocial impact of RAGT is different between pathological sub-groups and if the Lokomat influenced functional variables (Functional Independence Measure scale-FIM and parameters provided by the Lokomat itself). Thirty-nine consecutive patients (69% males, 54.0±18.0 years) eligible for Lokomat training, with etiologically heterogeneous walking disabilities (Parkinson's Disease, n = 10; Spinal Cord Injury, n = 21; Ictus Event, n = 8) were enrolled. Patients were assessed with the FIM before and after rehabilitation with Lokomat, and the PIADS was administered after the rehabilitative period with Lokomat. Overall the PIADS score was positive (35.8±21.6), as well as the three sub-scales, pertaining to "ability", "adaptability" and "self-esteem" (17.2±10.4, 8.9±5.5 and 10.1±6.6 respectively) with no between-group differences. All patients significantly improved in gait measure and motor FIM scale (difference after-before treatment values: 11.7±9.8 and 11.2±10.3 respectively), increased treadmill speed (0.4 ± 0.2m/s), reduced body weight support (-14.0±9.5%) and guidance force (-13.1 ± 10.7%). This pilot study indicates that Lokomat, in a real-world in-patient setting, may have a generalised approval, independent of disease, underlining the importance of the psycho-social framework for patients training with assistive robotic-devices.

Project description: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.

Project description:BackgroundStroke significantly affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in stroke survivors. Recent technological developments in powered robotics exoskeletons can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, we present the development and evaluation of a novel lower limb robotic exoskeleton, namely H2 (Technaid S.L., Spain), for gait rehabilitation in stroke survivors.MethodsH2 has six actuated joints and is designed to allow intensive overground gait training. An assistive gait control algorithm was developed to create a force field along a desired trajectory, only applying torque when patients deviate from the prescribed movement pattern. The device was evaluated in 3 hemiparetic stroke patients across 4 weeks of training per individual (approximately 12 sessions). The study was approved by the Institutional Review Board at the University of Houston. The main objective of this initial pre-clinical study was to evaluate the safety and usability of the exoskeleton. A Likert scale was used to measure patient's perception about the easy of use of the device.ResultsThree stroke patients completed the study. The training was well tolerated and no adverse events occurred. Early findings demonstrate that H2 appears to be safe and easy to use in the participants of this study. The overground training environment employed as a means to enhance active patient engagement proved to be challenging and exciting for patients. These results are promising and encourage future rehabilitation training with a larger cohort of patients.ConclusionsThe developed exoskeleton enables longitudinal overground training of walking in hemiparetic patients after stroke. The system is robust and safe when applied to assist a stroke patient performing an overground walking task. Such device opens the opportunity to study means to optimize a rehabilitation treatment that can be customized for individuals.Trial registrationThis study was registered at ClinicalTrials.gov ( https://clinicaltrials.gov/show/NCT02114450 ).

Project description:BackgroundRobotic-Assisted Gait Training (RAGT) may enable high-intensive and task-specific gait training post-stroke. The effect of RAGT on gait movement patterns has however not been comprehensively reviewed. The purpose of this review was to summarize the evidence for potentially superior effects of RAGT on biomechanical measures of gait post-stroke when compared with non-robotic gait training alone.MethodsNine databases were searched using database-specific search terms from their inception until January 2021. We included randomized controlled trials investigating the effects of RAGT (e.g., using exoskeletons or end-effectors) on spatiotemporal, kinematic and kinetic parameters among adults suffering from any stage of stroke. Screening, data extraction and judgement of risk of bias (using the Cochrane Risk of bias 2 tool) were performed by 2-3 independent reviewers. The Grading of Recommendations Assessment Development and Evaluation (GRADE) criteria were used to evaluate the certainty of evidence for the biomechanical gait measures of interest.ResultsThirteen studies including a total of 412 individuals (mean age: 52-69 years; 264 males) met eligibility criteria and were included. RAGT was employed either as monotherapy or in combination with other therapies in a subacute or chronic phase post-stroke. The included studies showed a high risk of bias (n = 6), some concerns (n = 6) or a low risk of bias (n = 1). Meta-analyses using a random-effects model for gait speed, cadence, step length (non-affected side) and spatial asymmetry revealed no significant differences between the RAGT and comparator groups, while stride length (mean difference [MD] 2.86 cm), step length (affected side; MD 2.67 cm) and temporal asymmetry calculated in ratio-values (MD 0.09) improved slightly more in the RAGT groups. There were serious weaknesses with almost all GRADE domains (risk of bias, consistency, directness, or precision of the findings) for the included outcome measures (spatiotemporal and kinematic gait parameters). Kinetic parameters were not reported at all.ConclusionThere were few relevant studies and the review synthesis revealed a very low certainty in current evidence for employing RAGT to improve gait biomechanics post-stroke. Further high-quality, robust clinical trials on RAGT that complement clinical data with biomechanical data are thus warranted to disentangle the potential effects of such interventions on gait biomechanics post-stroke.

Dataset Information

Robotic-Assisted Gait Training (RAGT) in Stroke Rehabilitation: A Pilot Study.

Objective

Design

Setting

Participants

Interventions

Main outcome measures

Results

Conclusions

Publications

Robotic-Assisted Gait Training (RAGT) in Stroke Rehabilitation: A Pilot Study.

Similar Datasets

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