Overground walking training with the i-Walker, a robotic servo-assistive device, enhances balance in patients with subacute stroke: a randomized controlled trial

Abstract

Background: Patients affected by mild stroke benefit more from physiological overground walking training than walking-like training performed in place using specific devices. The aim of the study was to evaluate the effects of overground robotic walking training performed with the servo-assistive robotic rollator (i-Walker) on walking, balance, gait stability and falls in a community setting in patients with mild subacute stroke.

Methods: Forty-four patients were randomly assigned to two different groups that received the same therapy in two daily 40-min sessions 5 days a week for 4 weeks. Twenty sessions of standard therapy were performed by both groups. In the other 20 sessions the subjects enrolled in the i-Walker-Group (iWG) performed with the i-Walker and the Control-Group patients (CG) performed the same amount of conventional walking oriented therapy. Clinical and instrumented gait assessments were made pre- and post-treatment. The follow-up observation consisted of recording the number of fallers in the community setting after 6 months.

Results: Treatment effectiveness was higher in the iWG group in terms of balance improvement (Tinetti: 68.4 ± 27.6 % vs. 48.1 ± 33.9 %, p = 0.033) and 10-m and 6-min timed walking tests (significant interaction between group and time: F(1,40) = 14.252, p = 0.001; and F(1,40) = 7.883, p = 0.008, respectively). When measured, latero-lateral upper body accelerations were reduced in iWG (F = 4.727, p = 0.036), suggesting increased gait stability, which was supported by a reduced number of falls at home.

Conclusions: A robotic servo-assisted i-Walker improved walking performance and balance in patients affected by mild/moderate stroke, leading to increased gait stability and reduced falls in the community.

Trial registration: This study was registered on anzctr.org.au (July 1, 2015; ACTRN12615000681550 ).

Keywords: Floor training; Gait; Rehabilitation; Robotic-assisted therapy; i-Walker.

Fig. 1

The i-Walker (Signed informed consent was provided by the patient for publication of this picture)

Fig. 2

CONSORT Flow chart

Fig. 3

a Mean and standard deviation for the percentage improvements (walking time reduction for 10-m walking test, 10MWT and walking distance improvement for 6-min walking test, 6MWT) in i-Walker group (iWG, dotted columns) and control group (CG, grey columns). b Box-plot of clinical scores for control group (CG, in the left of plots) and iWalker group (iWG, in the right of plots), pre (T0, grey boxes) and post (T1, white boxes) rehabilitation. The boxes show the lower quartile, median (bold line) and upper quartile values, the whiskers represent the most extreme values within 1.5 times the interquartile range from the ends of the box, the circles represent the outliers (data with values beyond the ends of the whiskers). c The percentage of patients divided by FAC-level at T0 (white bars) and T1 (black bars) for iWG (on the left) and CG (on the right). d Upright gait stability. Normalized adimensional values of anteroposterior and laterolateral acceleration RMS pre-rehabilitation (T0, grey bars) and post-rehabilitation (T1, white bars) for control group (CG) and i-Walker group (iWG). Stars indicate a statistically significant difference (p < 0.006)