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

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.

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments.

BACKGROUND: Wearable powered exoskeletons provide intensive overground gait training with patient's active participation: these features promote a successful active motor relearning of ambulation in stroke survivors. AIM: The aim of this study was to investigate the feasibility and the clinical effects of an overground exoskeleton-assisted gait training (OEAGT) in subacute stroke patients. DESIGN: Prospective, pilot pre-post, open label, non-randomized experimental study. SETTING: Four Italian neurological rehabilitation centers. POPULATION: Forty-eight subacute stroke patients were enrolled. Two patients dropped out because of medical problems. Data analysis was conducted on 46 subjects (56.84±14.29 years; 27 male; 29 ischemic; 24 left hemiparesis). METHODS: Patients underwent 15±2 sessions (60 min/session, 3-5 times/week) of OEAGT. Clinical and gait assessments were performed at the beginning (T1) and at the end (T2) of the training period: modified Barthel Index (BI), modified Ashworth Scale at Hip (MAS-H), Knee (MAS-K), and Ankle (MAS-A) level, Motricity Index (MI), Trunk Control Test (TCT), Functional Ambulation Classification (FAC), Walking Handicap Scale (WHS), 10-Meter Walking Test (10MWT), 6-Minute Walking Test (6mWT), Timed Up-and-Go test (TUG). The Technology Acceptance Model (TAM) questionnaire evaluated the acceptance of OEAGT by patients. Data stratification was performed using the time post the acute event and the onset of rehabilitation treatment, and the MI at T1. Wilcoxon's test (P<0.05) was used. RESULTS: All clinical scales significantly improved at T2; no statistically significant changes were reported for MAS-H, MAS-K, MAS-A. The 69.57% patients were able to walk at T1; 17.39% were not able to walk at T1 but regained ambulation at T2; and 13.04% were not able to walk at either T1 or T2. The ambulant patients showed a statistical improvement in speed measured during the 10MWT and in the distance covered over a time of 6 minutes (6mWT). The results from the TAM questionnaire showed that all subjects perceived the OEAGT positively. The data stratification analysis suggests that the OEAGT does not have any restriction of use. CONCLUSIONS: The OEAGT improved the clinical and gait outcomes in subacute patients. Randomized studies on larger samples are needed to confirm these data and to assess the efficacy of OEAGT. CLINICAL REHABILITATION IMPACT: Introduce innovative rehabilitation strategies based on customized OEAGT.

Efficiency in stroke management from acute care to rehabilitation: bedside versus telemedicine consultation.

BACKGROUND: Telemedicine has changed over the last years, becoming an integrated service used in various clinical settings such as stroke units or radiological departments, but also as an important tool for home rehabilitation. Assessment of usefulness and efficiency of performing teleconsultations to manage stroke from acute care hospital to tertiary care rehabilitation hospital has not been referred by scientific literature. AIM: This article analyzes the process of discharging stroke patients from acute care to intensive rehabilitation, based on the comparison between conventional bedside patient evaluations and teleconsultation patient evaluations, to assess efficiency and efficacy of two different discharging workflows. DESIGN: Retrospective study. SETTING: Consultations were carried out between the Acute Care Stroke Unit and the Stroke Rehabilitation Unit of Valduce Hospital System. POPULATION: The study included 257 stroke patients who underwent physiatric consultation during 2 years considered in this study and 101 patients were considered eligible for intensive rehabilitation treatment after a physiatric consultation. METHODS: We compared the efficiency and efficacy of the dismission workflow of bedside medical consultation and teleconsultation over a 12 months period. We considered the following outcome measures: time elapsed between consultation and Rehabilitation Unit admission, number of re-admissions to acute care hospital, complications occurred during rehabilitation, length of stay in the rehabilitation hospital and clinical outcomes of rehabilitation process. RESULTS: We observed a significant reduction in waiting time from the acute event to the admission in rehabilitation department, an improvement in efficiency of the admission process itself in the Rehabilitation Unit and a reduction of clinical complications occurred during rehabilitation period, without changes in rehabilitative outcomes. CONCLUSIONS: It has been highlighted that the use of telemedicine to perform medical consultation as a tool to evaluate patients eligible for tertiary care rehabilitation hospital admission from Stroke Care Unit is feasible and more efficient when compared with conventional bedside consultations. CLINICAL REHABILITATION IMPACT: This study reveals teleconsultations as a useful tool to improve efficiency of the stroke management workflow.

Wearable robotic exoskeleton for overground gait training in sub-acute and chronic hemiparetic stroke patients: preliminary results.

BACKGROUND: Recovery of therapeutic or functional ambulatory capacity in post-stroke patients is a primary goal of rehabilitation. Wearable powered exoskeletons allow patients with gait dysfunctions to perform over-ground gait training, even immediately after the acute event. AIM: To investigate the feasibility and the clinical effects of an over-ground walking training with a wearable powered exoskeleton in sub-acute and chronic stroke patients. DESIGN: Prospective, pilot pre-post, open label, non-randomized experimental study. SETTING: A single neurological rehabilitation center for inpatients and outpatients. POPULATION: Twenty-three post-stroke patients were enrolled: 12 sub-acute (mean age: 43.8±13.3 years, 5 male and 7 female, 7 right hemiparesis and 5 left hemiparesis) and 11 chronic (mean age: 55.5±15.9 years, 7 male and 4 female, 4 right hemiparesis and 7 left hemiparesis) patients. METHODS: Patients underwent 12 sessions (60 min/session, 3 times/week) of walking rehabilitation training using Ekso™, a wearable bionic suit that enables individuals with lower extremity disabilities and minimal forearm strength to stand up, sit down and walk over a flat hard surface with a full weight-bearing reciprocal gait. Clinical evaluations were performed at the beginning of the training period (t0), after 6 sessions (t1) and after 12 sessions (t2) and were based on the Ashworth scale, Motricity Index, Trunk Control Test, Functional Ambulation Scale, 10-Meter Walking Test, 6-Minute Walking Test, and Walking Handicap Scale. Wilcoxon's test (P<0.05) was used to detect significant changes. RESULTS: Statistically significant improvements were observed at the three assessment periods for both groups in Motricity Index, Functional Ambulation Scale, 10-meter walking test, and 6-minute walking test. Sub-acute patients achieved statistically significant improvement in Trunk Control Test and Walking Handicap Scale at t0-t2. Sub-acute and chronic patient did not achieve significant improvement in Ashworth scale at t0-t2. CONCLUSIONS: Twelve sessions of over-ground gait training using a powered wearable robotic exoskeleton improved ambulatory functions in sub-acute and chronic post-stroke patients. Large, randomized multicenter studies are needed to confirm these preliminary data. CLINICAL REHABILITATION IMPACT: To plan a completely new individual tailored robotic rehabilitation strategy after stroke, including task-oriented over-ground gait training.

A myocontrolled neuroprosthesis integrated with a passive exoskeleton to support upper limb activities.

This work aimed at designing a myocontrolled arm neuroprosthesis for both assistive and rehabilitative purposes. The performance of an adaptive linear prediction filter and a high-pass filter to estimate the volitional EMG was evaluated on healthy subjects (N=10) and neurological patients (N=8) during dynamic hybrid biceps contractions. A significant effect of filter (p=0.017 for healthy; p<0.001 for patients) was obtained. The post hoc analysis revealed that for both groups only the adaptive filter was able to reliably detect the presence of a small volitional contribution. An on/off non-linear controller integrated with an exoskeleton for weight support was developed. The controller allowed the patient to activate/deactivate the stimulation intensity based on the residual EMG estimated by the adaptive filter. Two healthy subjects and 3 people with Spinal Cord Injury were asked to flex the elbow while tracking a trapezoidal target with and without myocontrolled-NMES support. Both healthy subjects and patients easily understood how to use the controller in a single session. Two patients reduced their tracking error by more than 60% with NMES support, while the last patient obtained a tracking error always comparable to the healthy subjects performance (<4°). This study proposes a reliable and feasible solution to combine NMES with voluntary effort.