Dataset Information

Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects.

ABSTRACT:

Background

Overground Robot-Assisted Gait Training (o-RAGT) provides intensive gait rehabilitation. This study investigated the efficacy of o-RAGT in subacute stroke subjects, compared to conventional gait training.

Methods

A multicenter randomized controlled trial was conducted on 75 subacute stroke subjects (38 in the Experimental Group (EG) and 37 in the Control Group (CG)). Both groups received 15 sessions of gait training (5 sessions/week for 60 min) and daily conventional rehabilitation. The subjects were assessed at the beginning (T1) and end (T2) of the training period with the primary outcome of a 6 Minutes Walking Test (6MWT), the Modified Ashworth Scale of the Affected lower Limb (MAS-AL), the Motricity Index of the Affected lower Limb (MI-AL), the Trunk Control Test (TCT), Functional Ambulation Classification (FAC), a 10 Meters Walking Test (10MWT), the modified Barthel Index (mBI), and the Walking Handicap Scale (WHS).

Results

The 6MWT increased in both groups, which was confirmed by both frequentist and Bayesian analyses. Similar outcomes were registered in the MI-AL, 10MWT, mBI, and MAS-AL. The FAC and WHS showed a significant number of subjects improving in functional and community ambulation in both groups at T2.

Conclusions

The clinical effects of o-RAGT were similar to conventional gait training in subacute stroke subjects. The results obtained in this study are encouraging and suggest future clinical trials on the topic.

SUBMITTER: Molteni F

PROVIDER: S-EPMC7830339 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects.

Molteni Franco F Guanziroli Eleonora E Goffredo Michela M Calabrò Rocco Salvatore RS Pournajaf Sanaz S Gaffuri Marina M Gasperini Giulio G Filoni Serena S Baratta Silvano S Galafate Daniele D Le Pera Domenica D Bramanti Placido P Franceschini Marco M On Behalf Of Italian Eksogait Study Group

Brain sciences 20210114 1

<h4>Background</h4>Overground Robot-Assisted Gait Training (o-RAGT) provides intensive gait rehabilitation. This study investigated the efficacy of o-RAGT in subacute stroke subjects, compared to conventional gait training.<h4>Methods</h4>A multicenter randomized controlled trial was conducted on 75 subacute stroke subjects (38 in the Experimental Group (EG) and 37 in the Control Group (CG)). Both groups received 15 sessions of gait training (5 sessions/week for 60 min) and daily conventional re ...[more]

PMID: 33466749

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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: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:BackgroundOverground 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.MethodsAn 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.ConclusionsThere 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.ResultsEight 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.

Project description:BackgroundIndividuals requiring greater physical assistance to practice walking complete fewer steps in physical therapy during subacute stroke rehabilitation. Powered exoskeletons have been developed to allow repetitious overground gait training for individuals with lower limb weakness. The objective of this study was to determine the efficacy of exoskeleton-based physical therapy training during subacute rehabilitation for walking recovery in non-ambulatory patients with stroke.MethodsAn assessor-blinded randomized controlled trial was conducted at 3 inpatient rehabilitation hospitals. Patients with subacute stroke (< 3 months) who were unable to walk without substantial assistance (Functional Ambulation Category rating of 0 or 1) were randomly assigned to receive exoskeleton-based or standard physical therapy during rehabilitation, until discharge or a maximum of 8 weeks. The experimental protocol replaced 75% of standard physical therapy sessions with individualized exoskeleton-based sessions to increase standing and stepping repetition, with the possibility of weaning off the device. The primary outcome was walking ability, measured using the Functional Ambulation Category. Secondary outcomes were gait speed, distance walked on the 6-Minute Walk Test, days to achieve unassisted gait, lower extremity motor function (Fugl-Meyer Assessment), Berg Balance Scale, Patient Health Questionnaire, Montreal Cognitive Assessment, and 36-Item Short Form Survey, measured post-intervention and after 6 months.ResultsThirty-six patients with stroke (mean 39 days post-stroke) were randomized (Exoskeleton = 19, Usual Care = 17). On intention-to-treat analysis, no significant between-group differences were found in the primary or secondary outcomes at post-intervention or after 6 months. Five participants randomized to the Exoskeleton group did not receive the protocol as planned and thus exploratory as-treated and per-protocol analyses were undertaken. The as-treated analysis found that those adhering to exoskeleton-based physical therapy regained independent walking earlier (p = 0.03) and had greater gait speed (p = 0.04) and 6MWT (p = 0.03) at 6 months; however, these differences were not significant in the per-protocol analysis. No serious adverse events were reported.ConclusionsThis study found that exoskeleton-based physical therapy does not result in greater improvements in walking independence than standard care but can be safely administered at no detriment to patient outcomes. Clinical Trial Registration The Exoskeleton for post-Stroke Recovery of Ambulation (ExStRA) trial was registered at ClinicalTrials.gov (NCT02995265, first registered: December 16, 2016).

Dataset Information

Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects.

Background

Methods

Results

Conclusions

Publications

Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects.

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