Dataset Information

Robotic versus Conventional Overground Gait Training in Subacute Stroke Survivors: A Multicenter Controlled Clinical Trial.

ABSTRACT:

Background

Although stroke survivors can benefit from robotic gait rehabilitation, stationary robot-assisted gait training needs further investigation. In this paper, we investigated the efficacy of this approach (with an exoskeleton or an end-effector robot) in comparison to the conventional overground gait training in subacute stroke survivors.

Methods

In a multicenter controlled clinical trial, 89 subacute stroke survivors conducted twenty sessions of robot-assisted gait training (Robotic Group) or overground gait training (Control Group) in addition to the standard daily therapy. The robotic training was performed with an exoskeleton (RobotEXO-group) or an end-effector (RobotEND-group). Clinical outcomes were assessed before (T0) and after (T1) the treatment. The walking speed during the 10-Meter Walk Test (10 MWT) was the primary outcome of this study, and secondary outcomes were the 6-Minute Walk Test (6 MWT), Timed Up and Go test (TUG), and the modified Barthel Index (mBI).

Results

The main characteristics assessed in the Robotic and Control groups did not differ at baseline. A significant benefit was detected from the 10 MWT in the Robotic Group at the end of the study period (primary endpoint). A benefit was also observed from the following parameters: 6 MWT, TUG, and mBI. Moreover, patients belonging to the Robot Group outperformed the Control Group in gait speed, endurance, balance, and ADL. The RobotEND-group improved their walking speed more than the RobotEXO-group.

Conclusion

The stationary robot-assisted training improved walking ability better than the conventional training in subacute stroke survivors. These results suggest that people with subacute stroke may benefit from Robot-Assisted training in potentiating gait speed and endurance. Our results also support that end-effector robots would be superior to exoskeleton robots for improving gait speed enhancement.

SUBMITTER: Pournajaf S

PROVIDER: S-EPMC9861649 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Robotic versus Conventional Overground Gait Training in Subacute Stroke Survivors: A Multicenter Controlled Clinical Trial.

Pournajaf Sanaz S Calabrò Rocco Salvatore RS Naro Antonino A Goffredo Michela M Aprile Irene I Tamburella Federica F Filoni Serena S Waldner Andreas A Mazzoleni Stefano S Focacci Antonella A Ferraro Francesco F Bonaiuti Donatella D Franceschini Marco M TreadStroke Group

Journal of clinical medicine 20230105 2

<h4>Background</h4>Although stroke survivors can benefit from robotic gait rehabilitation, stationary robot-assisted gait training needs further investigation. In this paper, we investigated the efficacy of this approach (with an exoskeleton or an end-effector robot) in comparison to the conventional overground gait training in subacute stroke survivors.<h4>Methods</h4>In a multicenter controlled clinical trial, 89 subacute stroke survivors conducted twenty sessions of robot-assisted gait traini ...[more]

PMID: 36675371

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Project description:Background: The limitation to the use of ElectroMyoGraphy (sEMG) in rehabilitation services is in contrast with its potential diagnostic capacity for rational planning and monitoring of the rehabilitation treatments, especially the overground Robot-Assisted Gait Training (o-RAGT). Objective: To assess the barriers to the implementation of a sEMG-based assessment protocol in a clinical context for evaluating the effects of o-RAGT in subacute stroke patients. Methods: An observational study was conducted in a rehabilitation hospital. The primary outcome was the success rate of the implementation of the sEMG-based assessment. The number of dropouts and the motivations have been registered. A detailed report on difficulties in implementing the sEMG protocol has been edited for each patient. The educational level and the working status of the staff have been registered. Each member of staff completed a brief survey indicating their level of knowledge of sEMG, using a five-point Likert scale. Results: The sEMG protocol was carried out by a multidisciplinary team composed of Physical Therapists (PTs) and Biomedical Engineers (BEs). Indeed, the educational level and the expertise of the members of staff influenced the fulfillment of the implementation of the study. The PTs involved in the study did not receive any formal education on sEMG during their course of study. The low success rate (22.7%) of the protocol was caused by several factors which could be grouped in: patient-related barriers; cultural barriers; technical barriers; and administrative barriers. Conclusions: Since a series of barriers limited the use of sEMG in the clinical rehabilitative environment, concrete actions are needed for disseminating sEMG in rehabilitation services. The sEMG assessment should be included in health systems regulations and specific education should be part of the rehabilitation professionals' curriculum. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03395717.

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:Understanding the reorganization of the central nervous system after stroke is an important endeavor in order to design new therapies in gait training for stroke patients. Current clinical evaluation scores and gait velocity are insufficient to describe the state of the nervous system, and one aspect where this is lacking is in the quantification of gait symmetry. Previous studies have pointed out that spatiotemporal gait asymmetries are commonly observed in stroke patients with hemiparesis. Such asymmetries are known to cause long-term complications like joint pain and deformation. Recent studies also indicate that spatiotemporal measures showed that gait symmetry worsens after discharge from therapy. This study shows that muscle synergy analysis can be used to quantify gait symmetry and compliment clinical measures. Surface EMG was collected from lower limb muscles of subacute post-stroke patients (with an onset of around 14 days) from two groups, one undergoing robotic-assisted therapy (known as HAL group) and the other undergoing conventional therapy (known as Control group). Muscle synergies from the paretic and non-paretic limb were extracted with Non-Negative Matrix Factorization (NNMF) and compared with each other to obtain a gait symmetry index over therapy sessions. Gait events were tracked with motion tracking (for the HAL group) or foot pressure sensors (for the conventional therapy group). Patients from both groups were assessed over a 3-weeks long gait training program. Results indicated that there were no differences in muscle synergy symmetry for both groups of patients. However, the timing of muscle synergies were observed to be symmetrical in the HAL group, but not for the Control group. Intergroup comparisons of symmetry in muscle synergies and their timings were not significantly different. This could be due to a large variability in recovery in the Control group. Finally, stance time ratio was not observed to improve in both groups after their respective therapies. Interestingly, FIM and FMA scores of both groups were observed to improve after their respective therapies. Analysis of muscle coordination could reveal mechanisms of gait symmetry which could otherwise be difficult to observe with clinical scores.

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:Overground Robot-Assisted Gait Training (o-RAGT) appears to be a promising stroke rehabilitation in terms of clinical outcomes. The literature on surface ElectroMyoGraphy (sEMG) assessment in o-RAGT is limited. This paper aimed to assess muscle activation patterns with sEMG in subjects subacute post stroke after training with o-RAGT and conventional therapy. An observational preliminary study was carried out with subjects subacute post stroke who received 15 sessions of o-RAGT (5 sessions/week; 60 min) in combination with conventional therapy. The subjects were assessed with both clinical and instrumental evaluations. Gait kinematics and sEMG data were acquired before (T1) and after (T2) the period of treatment (during ecological gait), and during the first session of o-RAGT (o-RAGT1). An eight-channel wireless sEMG device acquired in sEMG signals. Significant differences in sEMG outcomes were found in the BS of TA between T1 and T2. There were no other significant correlations between the sEMG outcomes and the clinical results between T1 and T2. There were significant functional gains in gait after complex intensive clinical rehabilitation with o-RAGT and conventional therapy. In addition, there was a significant increase in bilateral symmetry of the Tibialis Anterior muscles. At this stage of the signals from the tibialis anterior (TA), gastrocnemius medialis (GM), rectus femoris (RF), and biceps femoris caput longus (BF) muscles of each lower extremity. sEMG data processing extracted the Bilateral Symmetry (BS), the Co-Contraction (CC), and the Root Mean Square (RMS) coefficients. Eight of 22 subjects in the subacute stage post stroke agreed to participate in this sEMG study. This subsample demonstrated a significant improvement in the motricity index of the affected lower limb and functional ambulation. The heterogeneity of the subjects' characteristics and the small number of subjects was associated with high variability research, functional gait recovery was associated with minimal change in muscle activation patterns.

Dataset Information

Robotic versus Conventional Overground Gait Training in Subacute Stroke Survivors: A Multicenter Controlled Clinical Trial.

Background

Methods

Results

Conclusion

Publications

Robotic versus Conventional Overground Gait Training in Subacute Stroke Survivors: A Multicenter Controlled Clinical Trial.

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