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

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, 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

Abstract

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.

Keywords: exoskeleton device; neurologic gait disorders; rehabilitation; robot-assisted gait training; stroke.

Conflict of interest statement

The authors certify that there is no conflict of interest with any financial organization or with the Ekso Bionics regarding the material discussed in the manuscript.

Figures

Figure 1
Figure 1
Flowchart.
Figure 2
Figure 2
6MWT distance comparison of the scores at T1 and T2. The p-value and the Bayes Factor (BF) of the intragroup effects are shown.
Figure 3
Figure 3
Motricity Index of the affected lower Limb (MI-AL) comparison of the scores at T1 and T2. The p-value and the BF of the intragroup effects are shown.
Figure 4
Figure 4
Trunk Control Test (TCT) comparison of the scores at T1 and T2. The p-value and the BF of the intragroup effects are shown.
Figure 5
Figure 5
10MWT velocity comparison of the scores at T1 and T2. The p-value and the BF of the intragroup effects are shown.
Figure 6
Figure 6
Modified Barthel Index (mBI) comparison of the scores at T1 and T2. The p-value and the BF of the intragroup effects are shown.
Figure 7
Figure 7
Percentage of subjects in each FAC category (0 = subject cannot walk; 1 = subject requires physical assistance from one person and contacts are continuous; 2 = subject requires physical assistance as in the previous category, but contact is intermittent or light; 3 = subject requires verbal supervision or standby help from one person without physical contact; 4 = subject can walk independently on level ground but requires help on stairs, slopes, or uneven surfaces; 5 = subject can walk independently anywhere) in both the EG and the CG at T1 and T2.
Figure 8
Figure 8
Percentage of subjects in each WHS category (1 = physiological gait; 2 = indoor gait with limitations; 3 = indoor gait without limitations; 4 = community ambulation with major limitations; 5 = community ambulation with some limitations; 6 = community ambulation without limitations) in both the EG and the CG at T1 and T2.

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