Dataset Information

Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation.

ABSTRACT:

Introduction

Practicality 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.

Objectives

To determine the feasibility of early, intense supplemental gait training in inpatient stroke rehabilitation, compare functional outcomes and the specific mode of delivery.

Design and setting

Assessor blinded, randomized controlled trial in a tertiary Inpatient Rehabilitation Facility.

Participants

Thirty acute post-stroke patients with unilateral hemiparesis (≥ 18 years of age with a lower limb MAS ≤ 3).

Intervention

Lokomat® or conventional gait training (CGT) in addition to standard mandated therapy time.

Main outcome measures

Number 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).

Results

The 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".

Conclusions

With 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.

SUBMITTER: Talaty M

PROVIDER: S-EPMC10552424 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation.

Talaty Mukul M Esquenazi Alberto A

Journal of neuroengineering and rehabilitation 20231004 1

<h4>Introduction</h4>Practicality 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.<h4>Objectives</h4>To determine the feasibility of early, intense supplemental gait training in inpatient stroke rehabilitation, compare functional outcomes and the specific mode of delivery.<h4>Design and setting</h4>Assessor blinded, randomized controlled trial in a tertiary Inpatient Rehab ...[more]

PMID: 37794474

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Project description:IntroductionElectromechanically-assisted gait training has been introduced in stroke rehabilitation as a means to enable gait training with a large number of reproducible and symmetrical task repetitions, i.e. steps. However, few studies have evaluated its impact on gait pattern functions. This study includes persons with no independent ambulation function at the start of a 4-week neurorehabilitation period in the sub-acute phase after stroke. The primary aim of the study was to evaluate whether the addition of electromechanically-assisted gait training to conventional training resulted in better gait pattern function than conventional training alone. The secondary aim was to identify correlations between overall gait quality and standardized clinical assessments.Participants and methodsSeventeen patients with no independent ambulation function who participated in a Prospective Randomized Open Blinded End-point study in the sub-acute phase after stroke were randomized into two groups; one group (n = 7) to undergo conventional training only (CONV group) and the other group (n = 10) to undergo conventional training with additional electromechanically-assisted gait training (HAL group). All patients were assessed with 3D gait analysis and clinical assessments after the 4-week intervention period. Overall gait quality as per the Gait Profile Score (GPS), as well as kinematic, and kinetic and other spatiotemporal metrics were collected and compared between intervention groups. Correlations between biomechanical and clinical outcomes were evaluated.ResultsBoth the CONV and HAL groups exhibited similar gait patterns with no significant differences between groups in any kinematic, kinetic parameters or other spatiotemporal metrics. The GPS for the paretic limb had a median (IQR) of 12.9° (7.8°) and 13.4° (4.3°) for the CONV and HAL groups, respectively (p = 0.887). Overall gait quality was correlated with independence in walking, walking speed, movement function and balance. We found no added benefit in gait pattern function from the electromechanically-assisted gait training compared to the conventional training alone.DiscussionThis finding raises new questions about how to best design effective and optimal post-stroke rehabilitation programs in patients with moderate to severe gait impairments to achieve both independent walking and optimal gait pattern function, and about which patients should be in focus in further studies on the efficacy of electromechanically-assisted gait training.Clinical trial registrationThe study was retrospectively registered at ClinicalTrials.gov, identifier (NCT02410915) on April 2015.

Project description:BackgroundStroke rehabilitation often uses the motor relearning concept that require patients to perform active practice of skill-specific training and to receive feedback. Treadmill training augmented with real-time visualisation feedback and functional electrical stimulation may have a beneficial synergistic effect on motor recovery. This study aims to determine the feasibility of this kind of enhanced treadmill training for gait rehabilitation among patients after stroke. A system for dynamic visualisation of lower-limb movement based on 3-dimentional motion capture and a computer timed functional electrical stimulation system was developed. Participants received up to 20-min enhanced treadmill training instead of their over-ground gait training once or twice a week for 6 weeks at Coathill hospital, Lanarkshire, United Kingdom. Number of training sessions attended, and training duration were used to assess feasibility. Ankle kinematics in the sagittal plane of walking with and without functional electrical stimulation support of the pre-tibial muscles were also compared and used to confirm the functional electrical stimulation was triggered at the targeted time.ResultsSix patients after stroke participated in the study. The majority of participants were male (5/6) with a age range from 30 to 84 years and 4/6 had left hemiplegia. All participants suffered from brain infarction and were at least 3 months after stroke. Number of training sessions attended ranged from 5 to 12. The duration of training sessions ranged from 11 to 20 min. No serious adverse events were reported. The computerised functional electrical stimulation to the pre-tibial muscles was able to reduce plantarflexion angle during the swing phase with statistical significance (p = 0.015 at 80%; p = 0.008 at 90 and 100% of the gait cycle).ConclusionsIt is safe and feasible to use treadmill gait training augmented with real-time visual feedback and computer-controlled functional electrical stimulation with patients after stroke in routine clinical practice.Trial registrationNCT03348215. Registered 20 November 2017.

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 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:BackgroundRegaining gait capacity is an important rehabilitation goal post stroke. Compared to clinically available robotic gait trainers, robots with an assist-as-needed approach and multiple degrees of freedom (AANmDOF) are expected to support motor learning, and might improve the post-stroke gait pattern. However, their benefits compared to conventional gait training have not yet been shown in a randomized controlled trial (RCT). The aim of this two-center, assessor-blinded, RCT was to compare the effect of AANmDOF robotic to conventional training on the gait pattern and functional gait tasks during post-stroke inpatient rehabilitation.MethodsThirty-four participants with unilateral, supratentorial stroke were enrolled (< 10 weeks post onset, Functional Ambulation Categories 3-5) and randomly assigned to six weeks of AANmDOF robotic (combination of training in LOPES-II and conventional gait training) or conventional gait training (30 min, 3-5 times a week), focused on pre-defined training goals. Randomization and allocation to training group were carried out by an independent researcher. External mechanical work (WEXT), spatiotemporal gait parameters, gait kinematics related to pre-defined training goals, and functional gait tasks were assessed before training (T0), after training (T1), and at 4-months follow-up (T2).ResultsTwo participants, one in each group, were excluded from analysis because of discontinued participation after T0, leaving 32 participants (AANmDOF robotic n = 17; conventional n = 15) for intention-to-treat analysis. In both groups, WEXT had decreased at T1 and had become similar to baseline at T2, while gait speed had increased at both assessments. In both groups, most spatiotemporal gait parameters and functional gait tasks had improved at T1 and T2. Except for step width (T0-T1) and paretic step length (T0-T2), there were no significant group differences at T1 or T2 compared to T0. In participants with a pre-defined goal aimed at foot clearance, paretic knee flexion improved more in the AANmDOF robotic group compared to the conventional group (T0-T2).ConclusionsGenerally, AANmDOF robotic training was not superior to conventional training for improving gait pattern in subacute stroke survivors. Both groups improved their mechanical gait efficiency. Yet, AANmDOF robotic training might be more effective to improve specific post-stroke gait abnormalities such as reduced knee flexion during swing. Trial registration Registry number Netherlands Trial Register ( www.trialregister.nl ): NTR5060. Registered 13 February 2015.

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:BackgroundAtypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation.MethodsA multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds with and without the device was conducted prior to and following the five training visits.ResultsAll 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P's < 0.05).ConclusionsWhen used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking.Trial registrationNCT03499210. Prospectively registered on March 28, 2018.

Dataset Information

Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation.

Introduction

Objectives

Design and setting

Participants

Intervention

Main outcome measures

Results

Conclusions

Publications

Feasibility and outcomes of supplemental gait training by robotic and conventional means in acute stroke rehabilitation.

Similar Datasets

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