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The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study.

ABSTRACT: Stroke 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.H2 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.Three 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.The 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.This study was registered at ClinicalTrials.gov ( https://clinicaltrials.gov/show/NCT02114450 ).

SUBMITTER: Bortole M

PROVIDER: S-EPMC4469252 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Project description:Robotic-assisted gait training (RAGT) devices allow intensive high repetition of the gait cycle in individuals with locomotor disability, with reduced therapist effort. In addition to usual rehabilitation, RAGT post-stroke improves the likelihood of regaining independent walking, with maximum efficacy identified in the acute and subacute phases of stroke. This study explores the usability and acceptance of RAGT among persons with stroke in an acute hospital setting and examines users' perceptions of two different modes of robotic assistance provided during rehabilitation. A mixed-methods approach comprised semi-structed interviews of end-user perspectives of RAGT in an acute hospital setting following stroke and two 10-point Likert scales rating how comfortable and how natural robotic gait felt using different assistance modes. Content analysis of qualitative data was undertaken with results synthesised by common meaning units. Quantitative data were reported using summary statistics, with Spearmann's correlation co-efficient examining the relationship between Likert scale ratings and measures of participants' stroke related disability. Ten individuals (6 men; 4 women; mean age of 64.5. ± 13 years) were recruited in an acute hospital setting following admission with a stroke diagnosis. Content analysis of interview transcripts identified discussion units centring around positive aspects of how helpful the device was, negative aspects related to set-up time, weight of the device and multiple instructions delivered during use. Initially participants identified that the device could look intimidating, and they feared falling in the device but they subsequently identified the correct mindset for using the device is to trust the technology and not be afraid. Mean ratings for device comfort (7.94 ± 1.4) and how natural walking felt (7.05 ± 1.9) were favourable. Interestingly, a strong relationship was identified, whereby the higher the level of disability, the more natural participants rated walking in the device during maximal assistance mode (rho = 0.62; p = 0.138). This study suggests individuals in the early phases of stroke perceive RAGT to be acceptable and helpful in the main, with some associated negative aspects. Walking in the device was rated as comfortable and natural. Those with greater disability rated the assisted walking as more natural.

Project description:BACKGROUND:Wearable powered exoskeletons are a new and emerging technology developed to provide sensory-guided motorized lower limb assistance enabling intensive task specific locomotor training utilizing typical lower limb movement patterns for persons with gait impairments. To ensure that devices meet end-user needs it is important to understand and incorporate end-users perspectives, however research in this area is extremely limited in the post-stroke population. The purpose of this study was to explore in-depth, end-users perspectives, persons with stroke and physiotherapists, following a single-use session with a H2 exoskeleton. METHODS:We used a qualitative interpretive description approach utilizing semi-structured face to face interviews, with persons post-stroke and physiotherapists, following a 1.5?h session with a H2 exoskeleton. RESULTS:Five persons post-stroke and 6 physiotherapists volunteered to participate in the study. Both participant groups provided insightful comments on their experience with the exoskeleton. Four themes were developed from the persons with stroke participant data: (1) Adopting technology; (2) Device concerns; (3) Developing walking ability; and, (4) Integrating exoskeleton use. Five themes were developed from the physiotherapist participant data: (1) Developer-user collaboration; (2) Device specific concerns; (3) Device programming; (4) Patient characteristics requiring consideration; and, (5) Indications for use. CONCLUSIONS:This study provides an interpretive understanding of end-users perspectives, persons with stroke and neurological physiotherapists, following a single-use experience with a H2 exoskeleton. The findings from both stakeholder groups overlap such that four over-arching concepts were identified including: (i) Stakeholder participation; (ii) Augmentation vs. autonomous robot; (iii) Exoskeleton usability; and (iv) Device specific concerns. The end users provided valuable perspectives on the use and design of the H2 exoskeleton, identifying needs specific to post-stroke gait rehabilitation, the need for a robust evidence base, whilst also highlighting that there is significant interest in this technology throughout the continuum of stroke rehabilitation.

Project description:BackgroundA novel electromechanical robotic-exoskeleton was designed in-house for the rehabilitation of wrist joint and Metacarpophalangeal (MCP) joint.ObjectiveThe objective was to compare the rehabilitation effectiveness (clinical-scales and neurophysiological-measures) of robotic-therapy training sessions with dose-matched conventional therapy in patients with stroke.MethodsA pilot prospective parallel randomized controlled study at clinical settings was designed for patients with stroke within 2 years of chronicity. Patients were randomly assigned to receive an intervention of 20 sessions of 45 min each, five days a week for four weeks, in Robotic-therapy Group (RG) (n = 12) and conventional upper-limb rehabilitation in Control-Group (CG) (n = 11). We intended to evaluate the effects of a novel exoskeleton based therapy on the functional rehabilitation outcomes of upper-limb and cortical-excitability in patients with stroke as compared to the conventional-rehabilitation. Clinical-scales- Modified Ashworth Scale, Active Range of Motion, Barthel-Index, Brunnstrom-stage and Fugl-Meyer (FM) scale and neurophysiological measures of cortical-excitability (using Transcranial Magnetic Stimulation) -Motor Evoked Potential and Resting Motor threshold, were acquired pre- and post-therapy.ResultsNo side effects were noticed in any of the patients. Both RG and CG showed significant (p < 0.05) improvement in all clinical motor-outcomes except Modified Ashworth Scale in CG. RG showed significantly (p < 0.05) higher improvement over CG in Modified Ashworth Scale, Active Range of Motion and Fugl-Meyer scale and FM Wrist-/Hand component. An increase in cortical-excitability in ipsilesional-hemisphere was found to be statistically significant (p < 0.05) in RG over CG, as indexed by a decrease in Resting Motor Threshold and increase in the amplitude of Motor Evoked Potential. No significant changes were shown by the contralesional-hemisphere. Interhemispheric RMT-asymmetry evidenced significant (p < 0.05) changes in RG over CG indicating increased cortical-excitability in ipsilesional-hemisphere along with interhemispheric changes.ConclusionRobotic-exoskeleton training showed improvement in motor outcomes and cortical-excitability in patients with stroke. Neurophysiological changes in RG could most likely be a consequence of plastic reorganization and use-dependent plasticity. Trial registry number: ISRCTN95291802.

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:BackgroundAlthough robotics assisted rehabilitation has proven to be effective in stroke rehabilitation, a limited functional improvements in Activities of Daily Life has been also observed after the administration of robotic training. To this aim in this study we compare the efficacy in terms of both clinical and functional outcomes of a robotic training performed with a multi-joint functional exoskeleton in goal-oriented exercises compared to a conventional physical therapy program, equally matched in terms of intensity and time. As a secondary goal of the study, it was assessed the capability of kinesiologic measurements-extracted by the exoskeleton robotic system-of predicting the rehabilitation outcomes using a set of robotic biomarkers collected at the baseline.MethodsA parallel-group randomized clinical trial was conducted within a group of 26 chronic post-stroke patients. Patients were randomly assigned to two groups receiving robotic or manual therapy. The primary outcome was the change in score on the upper extremity section of the Fugl-Meyer Assessment (FMA) scale. As secondary outcome a specifically designed bimanual functional scale, Bimanual Activity Test (BAT), was used for upper limb functional evaluation. Two robotic performance indices were extracted with the purpose of monitoring the recovery process and investigating the interrelationship between pre-treatment robotic biomarkers and post-treatment clinical improvement in the robotic group.ResultsA significant clinical and functional improvements in both groups (p < 0.01) was reported. More in detail a significantly higher improvement of the robotic group was observed in the proximal portion of the FMA (p < 0.05) and in the reduction of time needed for accomplishing the tasks of the BAT (p < 0.01). The multilinear-regression analysis pointed out a significant correlation between robotic biomarkers at the baseline and change in FMA score (R2 = 0.91, p < 0.05), suggesting their potential ability of predicting clinical outcomes.ConclusionExoskeleton-based robotic upper limb treatment might lead to better functional outcomes, if compared to manual physical therapy. The extracted robotic performance could represent predictive indices of the recovery of the upper limb. These results are promising for their potential exploitation in implementing personalized robotic therapy. Clinical Trial Registration clinicaltrials.gov, NCT03319992 Unique Protocol ID: RH-UL-LEXOS-10. Registered 20.10.2017, https://clinicaltrials.gov/ct2/show/NCT03319992.

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.

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The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study.

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