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European Journal of Physical and Rehabilitation Medicine 2019 December;55(6):710-21

DOI: 10.23736/S1973-9087.19.05574-6

Copyright © 2019 EDIZIONI MINERVA MEDICA

language: English

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

Michela GOFFREDO 1 , Eleonora GUANZIROLI 2, Sanaz POURNAJAF 1, Marina GAFFURI 2, Giulio GASPERINI 2, Serena FILONI 3, Silvano BARATTA 4, Carlo DAMIANI 1, Marco FRANCESCHINI 1, 5, Franco MOLTENI 2, on behalf of Italian EksoGait Study Group 

1 Department of Neurorehabilitation, IRCCS San Raffaele Pisana, Rome, Italy; 2 Villa Beretta Rehabilitation Center, Valduce Hospital, Costa Masnaga, Lecco, Italy; 3 Padre Pio Non-profit Foundation and Rehabilitation Centers, San Giovanni Rotondo, Foggia, Italy; 4 Department of Intensive Neuromotor Rehabilitation, USL Umbria 2, Trevi, Perugia, Italy; 5 San Raffaele University, Rome, Italy



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.


KEY WORDS: Stroke; Gait; Exoskeleton device; Neurologic gait disorders; Rehabilitation

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