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 str...

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Main Authors: Franco Molteni, Eleonora Guanziroli, Michela Goffredo, Rocco Salvatore Calabrò, Sanaz Pournajaf, Marina Gaffuri, Giulio Gasperini, Serena Filoni, Silvano Baratta, Daniele Galafate, Domenica Le Pera, Placido Bramanti, Marco Franceschini, on behalf of Italian Eksogait Study Group
Format: Article
Language:English
Published: MDPI AG 2021-01-01
Series:Brain Sciences
Subjects:
Online Access:https://www.mdpi.com/2076-3425/11/1/104
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author Franco Molteni
Eleonora Guanziroli
Michela Goffredo
Rocco Salvatore Calabrò
Sanaz Pournajaf
Marina Gaffuri
Giulio Gasperini
Serena Filoni
Silvano Baratta
Daniele Galafate
Domenica Le Pera
Placido Bramanti
Marco Franceschini
on behalf of Italian Eksogait Study Group
author_facet Franco Molteni
Eleonora Guanziroli
Michela Goffredo
Rocco Salvatore Calabrò
Sanaz Pournajaf
Marina Gaffuri
Giulio Gasperini
Serena Filoni
Silvano Baratta
Daniele Galafate
Domenica Le Pera
Placido Bramanti
Marco Franceschini
on behalf of Italian Eksogait Study Group
author_sort Franco Molteni
collection DOAJ
description 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.
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spelling doaj.art-b3b92a8417204fe7a3ec0dcb285b4cc42023-12-03T13:13:13ZengMDPI AGBrain Sciences2076-34252021-01-0111110410.3390/brainsci11010104Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke SubjectsFranco Molteni0Eleonora Guanziroli1Michela Goffredo2Rocco Salvatore Calabrò3Sanaz Pournajaf4Marina Gaffuri5Giulio Gasperini6Serena Filoni7Silvano Baratta8Daniele Galafate9Domenica Le Pera10Placido Bramanti11Marco Franceschini12on behalf of Italian Eksogait Study GroupVilla Beretta Rehabilitation Center, Valduce Hospital, Costa Masnaga, 23845 Lecco, ItalyVilla Beretta Rehabilitation Center, Valduce Hospital, Costa Masnaga, 23845 Lecco, ItalyNeurorehabilitation Research Laboratory, IRCCS San Raffaele Pisana, 00163 Rome, ItalyNeurorobotic Rehabilitation, IRCCS Centro Neurolesi “Bonino-Pulejo”, 98124 Messina, ItalyNeurorehabilitation Research Laboratory, IRCCS San Raffaele Pisana, 00163 Rome, ItalyVilla Beretta Rehabilitation Center, Valduce Hospital, Costa Masnaga, 23845 Lecco, ItalyVilla Beretta Rehabilitation Center, Valduce Hospital, Costa Masnaga, 23845 Lecco, ItalyFondazione Centri di Riabilitazione Padre Pio Onlus, 71013 Foggia, ItalySCRIN Trevi Dipartimento di Riabilitazione USL Umbria 2, 06039 Perugia, ItalyNeurorehabilitation Research Laboratory, IRCCS San Raffaele Pisana, 00163 Rome, ItalyNeurorehabilitation Research Laboratory, IRCCS San Raffaele Pisana, 00163 Rome, ItalyNeurorobotic Rehabilitation, IRCCS Centro Neurolesi “Bonino-Pulejo”, 98124 Messina, ItalyNeurorehabilitation Research Laboratory, IRCCS San Raffaele Pisana, 00163 Rome, ItalyBackground: 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.https://www.mdpi.com/2076-3425/11/1/104strokerobot-assisted gait trainingexoskeleton deviceneurologic gait disordersrehabilitation
spellingShingle Franco Molteni
Eleonora Guanziroli
Michela Goffredo
Rocco Salvatore Calabrò
Sanaz Pournajaf
Marina Gaffuri
Giulio Gasperini
Serena Filoni
Silvano Baratta
Daniele Galafate
Domenica Le Pera
Placido Bramanti
Marco Franceschini
on behalf of Italian Eksogait Study Group
Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects
Brain Sciences
stroke
robot-assisted gait training
exoskeleton device
neurologic gait disorders
rehabilitation
title Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects
title_full Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects
title_fullStr Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects
title_full_unstemmed Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects
title_short Gait Recovery with an Overground Powered Exoskeleton: A Randomized Controlled Trial on Subacute Stroke Subjects
title_sort gait recovery with an overground powered exoskeleton a randomized controlled trial on subacute stroke subjects
topic stroke
robot-assisted gait training
exoskeleton device
neurologic gait disorders
rehabilitation
url https://www.mdpi.com/2076-3425/11/1/104
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